Stem Cell Research Issues

China Stops Unapproved Stem Cell Treatments

2012-01-23T08:46:00.000-08:00

published January 10, 2012
Reuters

China has ordered a halt to all unapproved stem cell treatments and clinical trials, state media reported on Tuesday, as Beijing seeks to rein in the largely untested stem cell therapies now on offer across the country.

The Ministry of Health will stop accepting new applications for stem cell programs, a ban that will last until July and comes as China begins a one-year program to regulate the sector better, Xinhua cited a ministry spokesman as saying.

A growing number of hospitals and clinics in large cities in China have been offering stem cell therapies for treatment of diseases ranging from cancer and Alzheimer's to spinal cord injuries, treatments that are backed by little or no scientific evidence and which are considered at best experimental.

Some of these involve large general hospitals where patients pay thousands -- or even tens of thousands -- of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas, sparking what experts say is a dubious type of medical tourism.

According to patients, doctors and relatives of patients who spoke to Reuters earlier, patients have come away with little or no improvement and a number have died. Receipts seen by Reuters indicate that one of these hospitals is run by the Chinese army, or Peoples' Liberation Army (PLA).

The ministry spokesman said health providers could no longer charge money for experimental stem cell applications under the new order, which was jointly issued by China's State Food and Drug Administration (SFDA).

CAN IT BE ENFORCED?

Stem cell scientists and experts on medical ethics welcomed the development but they questioned how the health ministry could enforce the new order and reign in powerful arms of the Chinese government, like the army.

"One thing that is clear about the practice of stem cell medicine in China is that a lot of hospitals are affiliated with government organizations such as the army, the PLA, and the domestic police forces," said Doug Sipp, a researcher into the ethics of stem cell applications at the RIKEN Center for Developmental Biology in Japan.

Sipp said treatments were normally only introduced after they have proven to be effective in clinical trials and obtained approval from regulatory bodies.

"I will be curious to see whether this combination of the Ministry of Health and the SFDA is capable of exercising or enforcing the regulations on hospitals which are affiliated with the Chinese government," Sipp told Reuters by telephone.

Tuesday's announcement is similar to one made in 2009 when China ordered hospitals and clinics offering advanced medical technology to obtain approval or face closure, Sipp said, adding that the order back then did not make much impact.

The proliferation of unapproved stem cell therapies is not confined to China.

Experts have raised the alarm about patients turning up at clinics and hospitals in Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and are not recognized as standard treatment.

Last week, the United States' Food and Drug Administration issued a warning about unproven stem cell claims.

"This is a positive news because there has not been enough regulation, which damaged the reputation of this type of research," said David Siu, a cardiologist and stem cell expert at the University of Hong Kong.

Read more: http://www.foxnews.com/health/2012/01/10/china-stops-unapproved-stem-cell-treatments/#ixzz1kIhj4d54

Martin Luther King celebration recognizes six Braintree residents for contributions to town

2012-01-09T13:26:00.000-08:00

By Jessica Bartlett, Town Correspondent

Six Braintree residents will be recognized by the town of Braintree at the Dr. Martin Luther King, Jr. Annual Peacemaker Celebration this Thursday for embodying the spirit and character that the civil rights activist exhibited throughout his life.

The annual celebration, which the town has been doing since 1992, seeks to point out those in the community that have set an example, and although most other towns just offer the day off, Braintree officials said that continuing this tradition is important.

“It’s an effort to honor people that have embraced MLK’s spirit and example through their efforts on behalf of the community - to recognize what these people have done for the community and how it sets an example we should all aspire to,” said Peter Morin, chief of operations and staff for the town.

Sunny Shaw, a co-chair of the MLK Peacemaker Celebration Committee, agreed that the event, and the tradition, were important.

“It's also a nice way to bring the community together for a joyful celebration and remind people everyone has something they can give to make the community better,” she said.

Previous speakers have included Deval Patrick, before he was governor. The honoree selection committee chose Patrick to speak at the time because of his work as assistant attorney general in charge of civil rights in Washington, DC.

This year, recognition will go to five Braintree residents and one mystery honoree that will be named on Thursday night.

Amongst the honorees will be Ruth Powell, a member of the historical society, a library patron, and a member of the Finance Committee for many years.

According to Shaw, Powell has spent much of her free time volunteering on numerous town boards.

“She has been…a lifelong supporter of Braintree in terms of its history and its intellectual community,” Shaw said.

Gale and Bob Fraser, known for their work volunteering at the Braintree Youth Center, will also be recognized.

In addition to their work at the Youth Center, the Frasers have also volunteered with the Council on Aging and at the Marge Crispin Center, an organization founded in the 1970s to help those in the community struggling with basic needs.

“They are very involved in the community and are generous with their time and resources to help with several generations in Braintree,” Shaw said.

Tom Corcoran, who has served on the Board of Health for 20 years, is also a noted honoree during this year’s awards.

Born in Bedford, Corcoran moved to Braintree after finishing his military service with the US Army. He went to work in the funeral business for many years, until opening up his own advertising firm.

“Tom lends a helping hand whenever he can in the town of Braintree, which is why he’s being recognized,” said Bill Hedlund, co-chair of the MLK Peacemaker Celebration Committee along with Shaw.

A former member of the Forth of July Committee, Corcoran is also a sitting member of the Mayor’s Wellness Committee, and a past president of the town’s Lion’s Club.

Finally, Arthur Dalton will receive recognition for the many years of work on behalf of the town.

A Braintree resident born and raised, Dalton became a firefighter and eventually the Fire Chief. He has also gained much notoriety selling spring water through Dalton Water Company, a company he founded in 1971.

“He has spent most of his time during retirement working with his son at Dalton Water Co., and [has attended] many road races and events held in the town of Braintree,” Hedlund said. “Dalton water bottles were donated graciously by the company [at many of these events]. He’s been a true scout, a true townie that deserves recognition for lending a helping hand.”

The sixth awardee is being kept secret until the event, where he or she will be announced and recognized by the town.

Typically more than 100 people show up for the event, which this year will feature Braintree High School’s Show Choir, welcoming remarks from Mayor Joseph Sullivan, and numerous speeches by town officials on behalf of the honorees.

The event will be held at Braintree Town Hall on Thursday, Jan. 12 with a reception, catered by Fasano’s Catering, lasting from 6 p.m. till 7 p.m. The program is scheduled to begin at 7 p.m.

“The receipts selected this year as well as in past years have that outstanding character quality [of Martin Luther King],” Hedlund said. “They have enhanced the quality of life to the citizens of Braintree and the South Shore, which is why they have been selected as honorees at this event.”

3 arrested on stem cell charges

2012-01-06T13:46:00.000-08:00

Published: Dec. 28, 2011 at 10:47 PM

SAN ANTONIO, Dec. 28 (UPI) -- The FBI said Wednesday it arrested three men for their alleged roles in an operation that made stem cells and sold them to sick people without federal approval.

A fourth suspect remained at large, the FBI said in a release posted on its Web site.

The suspects in custody were identified as Francisco Morales, 52, of Brownsville, Texas; Alberto Ramon, 48, of Del Rio, Texas; and Vincent Dammai, 40, of Mount Pleasant, S.C. Morales was arrested Dec. 22, while Ramon and Dammai were arrested Tuesday.

The FBI said an arrest warrant had been issued for Lawrence Stowe, 58, of Dallas, who remained at large.

"This investigation identified a scheme whereby the suffering and hopes of victims in extreme medical need were used and manipulated for personal profit," FBI Special Agent in Charge Cory Nelson said. "The predatory and opportunistic nature of the crimes alleged in this indictment mirrors images from science fiction."

Federal authorities allege the four conspired to commit mail fraud and unlawfully distributed stem cells derived from umbilical cord blood. Morales and the others are accused of manufacturing, distributing and using stems cells produced from umbilical cord blood to perform procedures not approved by the U.S. Food and Drug Administration, to treat people who have cancer, amytrophic lateral sclerosis, multiple sclerosis and other autoimmune diseases.

FDA approval is required before stem cells can be marketed to the public and used to treat incurable diseases. The FDA has not determined stem cells are safe and effective in treating these diseases.

The indictment alleges that from 2007 to 2010 Morales falsely portrayed himself as a doctor who operated a medical clinic named Rio Valley Medical Clinic in Brownsville. He allegedly would meet patients in the United States and then travel to Mexico to perform the stem cell procedures.

Stowe allegedly marketed, promoted and sold stem cells along with other drug and biological products that don't have FDA approval for the treatment of cancer, ALS, MS and Parkinson's disease. Stowe ran The Stowe Foundation and Stowe Biotherapy Inc.

Ramon, a licensed midwife who operated The Maternity Care Clinic in Del Rio, allegedly obtained umbilical cord blood from birth mothers who were his patients and sold it to Global Laboratories. The Scottsdale, Ariz., company then allegedly sold the tissue to Dammai, a professor of pathology and laboratory medicine in Charleston, who allegedly created stem cells later sold by Global Laboratories.
© 2011 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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Stem cells used to produce blood platelets

2011-12-11T12:28:00.000-08:00

Reuters
By Deena Beasley
12/10/2011

SAN DIEGO (Reuters) - Scientists have for the first time created blood platelet cells by reprogramming stem cells derived from adult cells, offering the potential for a renewable supply of the fragile blood component.

Researchers at the Center for iPS Cell Research and Application at Kyoto University in Japan presented data at a meeting of the American Society of Hematology showing they were able to create the cells in the laboratory and confirm they had the same life span as normal human platelets when infused in mice.

"The next step will be to conduct a trial to determine whether our platelets can function in the human body," said Dr. Koji Eto, professor at the Kyoto center and senior author of the study.

Induced pluripotent stem cells, or iPS cells, are produced by manipulating ordinary human skin or blood cells back to a state in which they are able to differentiate into a number of different cell types.

When they were first discovered in 2006, iPS cells looked like a perfect solution to the ethical debate over the use of embryonic stem cells, but the process of producing non-mutated cells has proved challenging.

The limitation in using stem cells to produce platelets has been the ability to find a method that creates a large number of high-quality, functional platelets.

The Japanese researchers set out to create an immortalized cell line with a large number of high-quality megakaryocytes -- precursor cells that develop into platelets -- from stem cells that can be grown indefinitely and differentiate into a variety of cell types in the body.

They were able to produce a cell line that turned off certain genes to generate functional platelets. They then tested the cultured platelets by infusing them into immunodeficient mouse models and confirmed that they had the same life span as human platelets infused in mice.

"This has the potential of marching us forward to a day when we might to able to eliminate blood platelet shortages," said Dr. Charles Abrams, ASH secretary and associate chief of hematology/oncology at the University of Pennsylvania in Philadelphia.

In normal clotting, platelets stick together and form a plug at the site of an injured blood vessel, allowing the injured site to heal.

Legislator says stem cells helped

2011-12-10T19:05:00.000-08:00

Times Record News
By Alyssa Johnston
Posted December 3, 2011

State Rep. Rick Hardcastle, R-Vernon, participated in a recent round of autologous adult stem cell treatments to help his multiple sclerosis, similar to what Gov. Rick Perry had done in July.

Although the stem cells are not embryonic, doctors in the U.S. are still skeptical of the procedure because it is not yet approved by the Food and Drug Administration.

Adult stem cells are taken from the patient's fat, sent to a lab where they are developed, then reintroduced to the patient via intravenous therapy.

The treatments are used to treat patients with autoimmune diseases such as multiple sclerosis, fibromyalgia, Crohn's disease, Parkinson's and chronic obstructive pulmonary disease.

Hardcastle was diagnosed with MS almost 10 years ago and repeatedly said the treatments worked phenomenally for him.

"I'm walking on water and near bulletproof," Hardcastle said from a casino in Las Vegas, where he was with his wife for the National Finals Rodeo. "Since I had the third treatment, I have fished in the river in Alaska. I have walked up and down stairs without having to hold onto the handrail like a goon. It's just been phenomenal so far."

Hardcastle said just having his balance is an amazing thing because since he was diagnosed, his balance was one of the first things to go. He spoke at length about how easily he was able to walk the stairs at the Las Vegas event.

"Eight years ago, I was having to literally ... stop to step over a concrete barrier on a parking curb. I just walk across it now like I did 20 years ago," he said.

Hardcastle said the treatment is essentially the same that people have sought in Colombia, Costa Rica and Korea for the last 10 years. Some places in the U.S. now offer the treatment, making it more accessible than ever.

The FDA hasn't approved the procedure yet, but the agency hasn't disapproved of it, either.

"Under Texas law and federal law, it's not prohibited now because it's similar to saving your own blood — taking your own blood for reuse during surgery — because it's your own," Hardcastle said. "There are no outside medicines or stem cells included in the treatment."

Autologous stem cell therapy is expensive.

"You're talking about a basic treatment, just a one-time treatment is going to cost you $25,000 total," Hardcastle said.

He said he is trying to figure out how to help people pay for treatments if they are already on disability or don't have the ability to pay for the treatment.

He said payment plans for patients also are in the works.

Being able to tell a patient up front what they're going to have to pay and being able to have the treatments with a payment plan would be improvements.

Hardcastle also is working with insurance companies to get at least part of the treatment approved and paid for by insurance companies.

"I don't know anybody with any type of autoimmune disease that wouldn't spend $25,000 to get better," Hardcastle said. "How do you put a price tag on the fact that I can go look for a real job now as a retiring state rep and work again at 56 years old instead of just sitting around the house feeling sorry for myself?"

Hardcastle said area doctors showed great interest in being able to perform the treatments as alternative therapies in their offices. The plan would be for patients to visit their local neurologist to have fat extracted, shipped to the lab to be grown and enhance the stem cells, then ship the stem cells back to the office to be administered via IV therapy.

"I'm trying not to sound too excited because for one out of every five people, it doesn't work. It doesn't (give) phenomenal results. It'll still have some results, but they won't be phenomenal.

"So it's not a miracle cure by any stretch of the imagination, but it is a treatment that works."

He said, for example, one of the women who received treatments at the same time did not see phenomenal results, but she had some serious complications and believes every little bit she gets will help.

He said another man who took the treatment has Parkinson's disease, and his experience has been even better than his own.

Hardcastle said his hands no longer shake — a blessing that anyone with Parkinson's could never be thankful enough for.

Hardcastle said the more the procedure moved to North Texas, the more the cost can be in line.

"The dollars are sort of irrelevant compared to what we're paying for normal medicine, and compared to the fact that we get to feeling so much better so we can actually go do our jobs," he said.

Hardcastle talked about struggles faced by many people with autoimmune diseases, saying the entire family adapts to help you get through whatever day it is without affecting your disease more.

He said this year, he went through Thanksgiving like a champ, even playing on the floor and outside with his grandchildren.

Hardcastle said having MS for so long, he has built his life around not overexerting himself, so he is still out of shape, but he is exercising regularly and enjoys walking every morning.

"It hasn't made me any better looking, and I haven't grown any hair yet," Hardcastle said jokingly.

He said doctors aren't selling the treatments as a cure for any disease or disorder, but they sell it as a treatment for a wide range of diseases.

"My goal is to make it more available to the everyday person in Texas ... which includes getting insurance companies to decide what they're going to pay and getting doctors available that are willing to do it (since) there is no

controversy in it because it's your own stem cells."

© 2011 Times Record News. All rights reserved.

California stem cell agency needs to study itself

2011-12-06T19:06:00.000-08:00

Los Angeles Times
By Michael Hiltzik
December 7, 2011

The California Institute for Regenerative Medicine has downplayed the recent exit from the stem cell field by Geron, but the fiasco raises questions about how the agency does business and whether its addiction to hype does a disservice to patients and taxpayers.

For years, Geron Corp. had claimed to be in the vanguard among California companies engaged in stem cell research. So it was something of a stunner when it announced Nov. 14 that it was abandoning the stem cell field completely.

Geron's shares fell 20% the next day, but that was probably nothing compared with how far spirits must have fallen at the California stem cell agency, which just a few months earlier had made its highest-profile investment ever by awarding Menlo Park-based Geron a $25-million loan to help fund the first human trial of stem cell-based spinal cord therapy.

Since the announcement, the agency has been doing its darndest to reassure everyone that Geron's decampment isn't a huge embarrassment.

Such unexpected glitches are bound to happen when you're on the cutting edge of science, says the agency, which is known formally as the California Institute for Regenerative Medicine, or CIRM. "There are going to be fits and starts," its chairman, Jonathan Thomas, told me last week. Even so, he maintained, "we remain unwavering in our commitment to pursuing the science."

Agency officials point out that since Geron promptly refunded the $6.42 million it had drawn down from the CIRM loan, plus interest, this is a case of no-blood, no-foul. That's an exceedingly tolerant view of the ramifications, however. CIRM's approval of the loan last May had been preceded by what the agency says was "robust" peer review and proclaimed by the agency's founder and then-chairman, Robert Klein, to be a "landmark step for CIRM." In bailing out of the field, Geron halted a clinical trial that had already enrolled five patients.

So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers.

These questions are only going to become more important in the future, as CIRM prepares to ask California voters for new billions to supplement its original $3-billion bond issue authorized by voters through 2004's Proposition 71, which established the agency.

CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

These two goals have always been ethically and scientifically incompatible, and the Geron case points to why.

To begin with, there's evidence that CIRM, anxious to show progress toward bringing stem cell therapies to market, downplayed legitimate questions about the state of Geron's science and the design of the clinical trial. CIRM's anxiety sprang from the Proposition 71 campaign itself, which snowed California voters with exaggerated promises of cures for conditions such as Alzheimer's, Parkinson's, diabetes and spinal cord paralysis.

The latter was Geron's baby. The company last year won approval from the Food and Drug Administration to start injecting patients with cells derived from stem cells. This trial was a preliminary step toward showing that the process might help regenerate critically injured spinal tissue and end the subjects' paralysis.

But Geron had been criticized in the past for over-promising results. Some researchers questioned the design of its clinical trial and even whether spinal cord injury was the best subject for the first tests of stem cell therapies on humans. Says Joan Samuelson, a Parkinson's patient advocate who cast the sole dissenting vote on the CIRM board against the Geron loan: "I felt at the time that not all my questions had been answered about the readiness of that trial by that company."

None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using "new criteria" and thus the public might not find the result "meaningful." Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant.

It's proper to ask whether Geron was the right partner for CIRM under any circumstances. The company has never recorded an annual profit since its founding in 1990. That's not unusual among early-stage research firms, but Geron was also undergoing management turmoil. Its longtime chief executive, Thomas Okarma, a sedulous promoter of stem cell research, abruptly stepped down in February. The new CEO, John Scarlett, wasn't hired until the end of September, five months after the CIRM loan was approved; six weeks later he pulled the plug on Geron's stem cell efforts, saying that the company would henceforth concentrate on more promising cancer research.

CIRM learned about Geron's move like the rest of the world — from the firm's public announcement on Nov. 14.

Other aspects of the Geron deal should give Californians pause. For example, five of the CIRM board's 28 members had to recuse themselves from the vote because of conflicts of interest. That underscores the structural weakness of the board, which is drawn almost entirely from patient advocacy groups and biomedical research institutions angling for grants.

"These conflicts of interest are built into the governing board" by Proposition 71, observes Marcy Darnovsky of the Oakland-based Center for Genetics and Society, a longtime CIRM critic. But Proposition 71 also makes it almost impossible to restructure the board.

Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: "CIRM is turning stem cells into cures."

Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer.

Michael Hiltzik's column appears Sundays and Wednesdays. His latest book is "The New Deal: A Modern History." Reach him at mhiltzik@latimes.com, read past columns at latimes.com/hiltzik, check out facebook.com/hiltzik and follow @latimeshiltzik on Twitter.

Copyright © 2011, Los Angeles Times

Top-grade stem cells seen boosting research trials

2011-12-06T19:02:00.001-08:00

By Kate Kelland
LONDON | Tue Dec 6, 2011

(Reuters) - British scientists have made the first human embryonic stem cells of a high enough grade to use in patients and deposited them in a public stem cell bank for development in human trials by drug companies and researchers by 2014.

A team from King's College London said on Monday they were submitting two clinical-grade stem cell lines to the UK Stem Cell Bank (UKSBC), which will test and validate them before offering them to researchers.

This could speed the path towards new stem-cell treatments for conditions like blindness, severe injury or heart disease.

"This first batch of cells is the culmination of nearly 10 years of research. This is a significant milestone," said Peter Braude, who led the King's team.

The cells are the first to be grown completely free from animal-derived products, known as "xeno-free," and developed specifically to be of clinical grade and for public use.

The hope is that the cells will be grown and processed by the bank to feed cell stocks for human trials and, beyond that, patient treatments.

The cells have the potential to become the "gold standard" lines for developing new stem cell based therapies for use in regenerative medicine trials in patients, Braude told reporters at a briefing.

It is likely to be many years before treatments are fully developed and licensed, but the cells could be used in human trials of potential therapies by 2014, the team said.

Stem cells are the body's master cells, the source for all other cells. Scientists say they could transform medicine, providing treatments for blindness, spinal cord and other severe injuries, as well as generating cells for damaged organs.

Human embryonic stem (hES) cells can be grown in the laboratory indefinitely while retaining their capacity to develop into specialized cell types, such as nerve or heart muscle cells, which can then be used in clinical trials.

The UK Stem Cell bank already has more than 90 research grade stem cell lines for use in laboratory studies, but as yet has no clinical grade xeno-free lines for use in human trials.

"In the future, patients hoping for the benefit of regenerative medicine for serious medical conditions caused by illness, injury and ageing can expect improved progress on cures or amelioration from hES cell-based therapy," said Dusko Ilic, a senior lecturer in stem cell science at King's.

A few companies, such as Pfizer and Advanced Cell Technology, are already conducting or are about to start human trials using hES cells -- which are harvested from embryos -- to test their potential for repairing spinal cord injuries and eye disorders like macular degeneration.

But the hES cell lines for these early trials were reclassified from "research grade" to "clinical grade" for specific short-term clinical studies in selected disease areas.

Braude said this is not considered appropriate for the future of cell therapy because of the expense of extra testing and reclassification, and the potential risks.

"While it might be reasonable to incur additional risks for these early pioneering studies, it is not reasonable to accept these risks for the long-term future," he said. "Therefore the highest standard of xeno-free lines are urgently needed."

Braude's team's cells were grown from frozen embryos donated by patients who had had in-vitro fertilization (IVF) treatment and no longer wanted to use their remaining stored embryos. The embryos would otherwise have been discarded, Braude said.

Glyn Stacey, head of the UKSCB, said these first clinical grade lines would be an "important resource" and an initial step towards the bank's aim to make available a panel of tested clinical grade lines within the next three years.

"The process of testing will be rigorous and not all cells lines received will make the grade," he said.

(Editing by David Cowell)

Stem Cell Therapy to See Newer, Safer Forms

2011-12-02T21:19:00.000-08:00

Posted by Janis Esch on December 2, 2011
ThirdAge.com

Newer and safer forms of stem cell therapy will likely overtake research into the use of human embryonic stem cells, the scientist whose team cloned Dolly the sheep told his peers at a stem cell conference in La Jolla, California.

Direct "reprogramming" of adult cells into the type needed for therapy is gradually becoming a reality, Ian Wilmut told an audience of several hundred at the Salk Institute at the annual Stem Cell Meeting on the Mesa. Such a feat was once thought impossible, but in recent years it has been demonstrated in at least two publications, he said.

These reprogrammed cells appear likely to provide the anticipated benefits of embryonic stem cells without their risks, such as forming tumors. That risk will make government very reluctant to approve the use of cells derived from embryonic cells when a safer alternative is feasible, said Wilmut, whose team of researchers cloned Dolly the sheep nearly 15 years ago.

With its $3 billion stem cell program, California placed a big bet on the field known as regenerative medicine, hoping for a big payoff in improving health and boosting its large biotech industry. A major goal is to grow replacement tissues or organs for insulin-producing cells that can be transplanted into diabetics. San Diego academic centers play a big part in that effort. They recently opened a new $127 million stem cell research center.

(To read the rest of this article, click on the link in the title above.)

Stem Cell Researchers Engineer T-Cells to Fight Cancer

2011-11-30T17:37:00.000-08:00

ThirdAge.com
Posted by Janis Esch on November 30, 2011

U.S. researchers say they've shown that blood stem cells can be engineered to create cancer-killing T-cells that seek out and attack a human melanoma.

Jerome Zack -- a scientist with the University of California, Los Angeles, Jonsson Comprehensive Cancer Center and the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research -- said the tests, conducted on mice, prove blood stem cells can be genetically altered in a living organism to fight cancer.

"We knew from previous studies that we could generate engineered T-cells, but would they work to fight cancer in a relevant model of human disease, such as melanoma," Zack said Tuesday in a release.

In four of the nine mice studied, the antigen-expressing melanomas were eliminated. In the other five mice, the antigen-expressing melanomas decreased in size.

Researcher Dimitrios Vatakis said the approach turned a few engineered stem cells into an army of T-cells that responded to the presence of the melanoma antigen.

"These cells can exist in the periphery of the blood and if they detect the melanoma antigen, they can replicate to fight the cancer," he said.

The study appeared Monday in the early online edition of the Proceedings of the National Academy of Sciences.

Source: Yellowbrix

Geron Ends Embryonic Stem Cell Research

2011-11-21T22:30:00.000-08:00

Boomer Health and Lifestyle
Posted by Sarah Long on November 21, 2011

Geron Corp. announced Monday it will no longer be using embryonic stem cells in its research.

The biotech company cited financial difficulties in continuing the research, according to the Los Angeles Times. It will cut 66 jobs and halt research into potential cures for spinal cord injuries, diabetes and heart disease.

Geron will focus the rest of its resources on developing cancer drugs, the company said in its statement.

“We’re not doing this because we were souring on the field, or as a result of any problems -- we have not had any safety issues at all,” said Geron Chief Executive Officer John Scarlett Scarlett in a telephone interview with Business Week. “We need to focus our resources on advancing these phase 2 clinical trials of our two cancer drugs.”

Geron has already been conducting an early clinical trial of embryonic stem cell-based therapy for spinal cord injuries, the Los Angles Times reports. Though the four patients already participating will continue to be monitored for the treatment's safety, no new subjects will be added to the study.

Shares for Geron dropped 20 percent to $1.75 at closing, according to Business Week. Its shares have fallen 66 percent this year.

Operation marks another step forward in stem cell research

2011-11-21T22:28:00.000-08:00

By Miriam Falco
CNN
Mon November 21, 2011

Atlanta (CNN) -- A 50-year-old man from Trion, Georgia, is the first person to be injected with stem cells in the upper part of the spinal cord, making him yet another pioneer in the scientific quest to use stem cells to heal.

Richard Grosjean received the treatment Friday. He is part of an ongoing FDA-approved clinical trial that is testing the safety of injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig's disease.

Grosjean's ALS was diagnosed a little over two years ago, his wife, Tracie, told CNN. He can still walk with a cane, but he has a lot of weakness on his left side and has trouble with his speech.

"I'm pretty much his voice for him," Tracie Grosjean said.

Through his wife, Grosjean says "he has 100% confidence in Emory and Dr. (Jonathan) Glass and Dr. (Nicholas) Boulis and the good Lord that good things will come" from the trial.

While the Grosjeans know this procedure is likely to be more helpful to others in the future who have to deal with this "horrible disease," they have hope and faith that some good will come of this for them, too. In addition to praising Emory University, Tracie also praises her husband's employer, Mount Vernon Mills, which she says has "bent over backwards" to keep him employed throughout his illness giving him a sense of purpose.

The cause of ALS is unknown, but the disease is fatal because nerve cells, or neurons, in the brain and spinal cord needed to tell muscles to move, waste away or die. Early in the disease, patients have difficulty speaking and walking, both symptoms Grosjean now has. Eventually, the disease cuts off communication between the brain and chest muscles, so patients can no longer breathe.

Most people die from respiratory failure, according the National Institutes of Health, and most patients die within three to five years of diagnosis.

The team of researchers in this clinical trial is headed by University of Michigan neurologist Dr. Eva Feldman, who designed the trial; neurologist Glass, who is in charge of the clinical trial at Emory University in Atlanta, where patients are getting the injections; and Emory neurosurgeon Boulis, who invented the structure used to safely inject the stem cells into the patient.

In an operation than lasted about four hours, Grosjean received five injections into the cervical, or neck, area of his spinal cord, each delivering 100,000 cells. The cells came from Maryland-based biotech company Neuralstem, which is funding this clinical trial and devised a procedure to grow millions and millions of motor neuron cells from the donated spinal cord tissue of an 8-week-old aborted fetus.

These are not embryonic stem cells, like the ones used by California-based company Geron, which has injected cells grown from human embryonic stem cells into the spines of at least four patients with complete spinal cord injuries.

Embryonic stem cells have the ability to become any type of cell in the body. One week ago, Geron decided to stop its trial because it was too expensive to continue.

The cells in this ALS trial were taken from the spinal cord of the fetus, so they have already gone down the path of becoming nerve cells. Researchers are hoping to show that injecting neural stem cells -- the precursors to nerve cells -- into the spinal cord of ALS patients is safe.

Ultimately, the hope is that by injecting the cells into the neck, above the lungs, where the mostly deadly damage is done by ALS, these neural stem cells will reconnect communication from the brain to the muscles, keeping patients alive longer and maybe, one day, curing them.

But that is not the point of the trial at this time. At this point the goal is still to establish that injecting stem cells is safe for the patient, won't cause more damage to the patient, and won't lead to the patient reject the cells. Early data from the first 12 patients, who had injections in the lower back, shows this procedure is safe.

Injecting anything into the spinal cord is very dangerous because it can cause serious damage. To avoid injuring the spinal cord, which is always moving as the patient breathes, the needle delivering the stem cells has to move along with the body.

Boulis invented an apparatus that resembles a miniature oil rig mounted on to the patient's spine. It moves with every breath and holds a super-fine needle through which to inject the stem cells. To prepare for these surgeries, Boulis and his fellow surgeons practiced mounting the apparatus on pigs, which are close in size to humans.

The first 12 patients in this clinical trial had the "rig" mounted on their lower back, giving surgeons a flatter surface to work with.

But the injection site on Grosjean is on the neck, posing a new challenge for Boulis.

"It didn't fit exactly as I had envisioned it," he said immediately after the surgery. "In fact, I ended up applying it much in the same way that I had applied it in pigs, as opposed to how I had envisioned it in humans, and that gave us nice solid fixation."

Boulis screwed the structure to the spine on one side, but to the skull on the other side.

With the spinal cord exposed after removing part the spine and peeling back layers of muscle and membranes protecting the cord, the injections slowly began. They have to be slow -- injecting the cells too fast alone can damage the cord or the cells can spill out, never having a chance to nestle into the spinal cord.

After the third injection went smoothly, Boulis paused to note what they were accomplishing at this moment. After the surgery he said, "it is a big milestone for us. ... I think the biggest thing about this is that I feel like we finally arrived."

That's because Boulis and his colleagues have come a long way, through trial design; to testing the cells in mice to ensure they don't cause tumors, which sometimes happens with stem cells; to inventing the needle-holding oil-rig-like apparatus; to practicing on many pigs; to perfecting how attach the device to patients.

"Finally we're beginning to inject cells into the segments that control the diaphragm, and to the extent that we are able to do that safely ... this is where we keep people breathing," Boulis said.

And that's ultimately what this clinical trial is about.

Glass described Friday's surgery as being at the beginning of crossing an important threshold. "I think it's a huge step forward. I don't want anyone to think that we have a cure for this disease. We don't. But we now have a whole other way to approach it, and that's really what's exciting and important."

Feldman described the day as the most momentous in their pursuit of using stem cells in the treatment of ALS.

"I have spent over 25 years taking care of patients with ALS, and I feel today I can go back to them and give them hope," she said.

Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, agrees, calling the progress in this clinical trial a "big step forward."

Every clinical trial that can show a stem cell procedure to be safe is important, he said.

"These are tough diseases," Trounson said. He agreed that being able to safely inject stem cells into the cervical area of the spinal cord is an important step forward for patients with ALS and potentially other neurodegenerative diseases such as multiple sclerosis.

Grosjean, Glass and Boulis are quick to point out that they have to replicate this surgery in other patients. Two more patients will receive the same cell dosages in the near future in this part of the clinical trial.

After telling Tracie Grosjean how well the surgery went, Glass was excited and cautiously optimistic.

"We're moving forward," he said. "We don't have a treatment yet, we don't have cure yet and there's no evidence yet even putting these stem cells on the spinal cord is going to either slow the disease or prevent progression or even make it better."

Three days after the surgery, Boulis said the patient was doing well. Neurologically he is where he was before the surgery. His legs and arms are moving, confirming what was monitored throughout the entire surgery. The spinal cord was not damaged.

Tracie Grosjean said her husband is still in pain, which doctors say is expected given the surgery. But she said the doctors tell them he's doing great and they hope be home in time for Thanksgiving.

Criminalize Abortion, Stem Cell Research, and the Birth Control Pill?

2011-11-07T12:59:00.000-08:00

Posted: 11/7/11
Don C. Reed

For a glimpse into a Republican Religious Right wishlist, check out Amendment 26, in Mississippi.

Does Mississippi need more troubles? This is one of the most impoverished states in the nation. Of the 100 poorest counties in America, 14 are in Mississippi. In this Republican-controlled state, dominated by the Religious Right, Mississippi schools have the third lowest test scores in the nation. Infant mortality is tragically high, as is teenage pregnancy -- with all respect to its hard-working citizens, Mississippi might be described a failed state.

Things are about to get worse.

November 8, Mississippi decides if fertilized human eggs are more important than full-grown people.

Here is what voters will confront in the ballot box: Amendment 26 would:

"...amend the Mississippi Constitution to define the word 'person' or 'persons' ... to include every human being from the moment of fertilization..."

Every fertilized egg would become a "person" with full legal rights.

This is nonsense. When a woman has a heavy menstrual flow, that often means she is shedding a fertilized egg -- does that mean a human being just died?

What's next? Are we supposed to have a little funeral for the contents of a tampon?

Sadly, this is no joke. However ridiculous it may seem, the consequences of Amendment 26 may be deadly serious.

Amendment/Initiative 26 is premised on what may at first seem a reasonable goal: to end abortion.

But like Prohibition, which sought to end alcohol use and instead gave us organized crime, unintended consequences may be devastating.

In addition to the back alley abortions which will happen, and which will take women's lives, there will also be financial costs: a flood of lawsuits, both from those seeking to expand the new powers, while seeking to block them. Legal bills must be paid by Mississippi, which can ill afford them.

But lawsuit costs are the least of our worries.

Consider just a few of the problems Mississippi's people will suffer:

First, the law is cruel, allowing for no exceptions. No pregnancy may ever be terminated: not even the incestual rape of a minor.

After this horrendous attack, the woman (or girl) would required by law to bear the child of the rapist; if she chose the "morning-after" pill to end the pregnancy, she would, according to the undeniable consequences of the law, be subject to prosecution for murder.

What about a pregnancy which endangers the life of the mother? Again, no exceptions are listed.

A miscarriage could be investigated like a crime scene, to find out if it was an abortion. Supporters of 26 deny this would happen, but, according to Salon, "in countries with absolute abortion bans, like El Salvador, women are regularly investigated and jailed when found to have induced miscarriages."

Many forms of birth control will be criminalized, including very likely "the pill".

Does this make sense?

What business of big government is it if an adult woman chooses to take birth control pills?

The In Vitro Fertility (IVF) method of assisted childbirth will be cripplingly restricted, if not outright banned. Why? When a childless couple tries the IVF method, mixing sperm and egg in a petri dish, they usually end up with 15-20 blastocysts, from which they choose 2-3 of the strongest to implant. The others are either frozen (child abuse if the biological tissue is considered a human being) or flushed away, which would be "murder".

And the embryonic stem cell research may one day help my paralyzed son stand up from his wheelchair? Out of the question. Stem cells might cure millions are made from IVF blastocysts, biological tissue that would otherwise be discarded.

Amendment 26 would chill the advancement of biomedicine, an industry with good-paying jobs, and a hope for cure for suffering millions.

As the name implies, embryonic stem cells are cells -- not children, cells.

To make a child out of the contents of a petri dish is biologically impossible.

This is the personhood issue, which supporters hope will be a national Constitutional Amendment.

Tomorrow, Tuesday the 8th of November, it will be up to the citizens of Mark Twain's state to decide.

As Mississippian Dr. Randall S. Heines put it:

Amendment 26, if passed, would turn over many issues which had been between patient and doctor, and give them to the courts to decide. Do we really want the government intruding on so many of our private decisions?

For more information go to http://www.votenoon26.org. Give them a buck if you can, the opposition is heavily funded and organized.

There are important ads that could still be funded, with a few dollars from us. For instance, former Governor Haley Barbour, one of the most conservative right-to-life Republicans in the country, says he has "concerns" about Amendment 26.

As should we all.

Follow Don C. Reed on Twitter: www.twitter.com/diverdonreed

Stem Cells Take Aim

2011-10-31T17:22:00.000-07:00

October 31, 2011
Focus - news from Harvard

Programming cells to home to specific tissues may enable more effective cell-based therapies.

Stem cell therapies hold enormous potential to address some of the most tragic illnesses, diseases, and tissue defects world-wide. However, the inability to target cells to tissues of interest poses a significant barrier to effective cell therapy. To address this hurdle, researchers at Brigham and Women’s Hospital (BWH) have developed a platform approach to chemically incorporate homing receptors onto the surface of cells. This simple approach has the potential to improve the efficacy of many types of cell therapies by increasing the concentrations of cells at target locations in the body.

These findings are published online in the journal Blood on October 27, 2011.

For this new platform, researchers engineered the surface of cells to include receptors that act as a homing device. “The central hypothesis of our work is that the ability of cells to home to specific tissues can be enhanced, without otherwise altering cell function,” said Jeffrey M. Karp, HMS assistant professor of medicine and co-director of the Regenerative Therapeutics Center at BWH and “By knowing the ‘zip code’ of the blood vessels in specific tissues, we can program the ‘address’ onto the surface of the cells to potentially target them with high efficiencies.”

While conventional cell therapies that include local administration of cells can be useful, they are typically more invasive with limited potential for multiple doses. “You can imagine, that when the targeted tissue is cardiac muscle, for example to treat heart attacks or heart failure, injecting the cells directly into the heart can be an invasive procedure and typically this approach can only be performed once,” said Dr. Karp, also a principal faculty member of the Harvard Stem Cell Institute and affiliate faculty at Harvard-MIT Division of Health Sciences and Technology.

Adapted from a Brigham and Women’s Hospital news release. For the complete story, please visit the BW newsroom.

Brigham and Women’s Hospital is a teaching affiliate of Harvard Medical School.

Adult Stem Cells: Is the Media Catching On?

2011-10-24T17:34:00.000-07:00

Reflections of a Paralytic
October 21st, 2011

When it comes to stem cell research, adult stem cells (ASC) have been outperforming their unethical, embryonic counterparts for years now. While embryonic stem cell (ESC) research only just last year began its very first trial on humans and is still trying to overcome issues with tumor formation and other harmful, deadly side-effects in animal studies for the past 20 years, adult stem cells have been successfully used in numerous adult studies for years and for many different diseases and conditions. The reaction from the media, as well as many in the scientific community, has been to ignore or belittle the positive results of ASC research while touting the “hope” and “promise” of ESCs. But, I recently came across a few articles that are way out of the norm for both the media and the mainstream scientific community.

ESPN The Magazine has an interesting article this week about how many professional athletes are seeking stem cell treatments for their injuries – adult stem cell treatments. Most recently, Indianapolis Colts quarterback Peyton Manning traveled to Europe for a treatment using his own fat cells to help his ailing neck. Other notable athletes to travel abroad for similar treatments are Pittsburgh Steelers wide receiver Hines Ward, NFL defensive end Jarvis Green and Yankees starter Bartolo Colon.

What is really amazing about the ESPN article is that it does not mention embryonic stem cells. At all. The entire article is focused on the development of treatments with adult stem cells and how progress of this research in the United States is being slowed down by the FDA.

Another interesting, but short, article is this opinion piece in New Scientist “In praise of stem-cell simplicity.” It is a rare acknowledgement by a very ESC research friendly scientific publication acknowledging of the effectiveness of ASC research. What’s more, they do it without a hint of skepticism, though they still maintain that “all avenues” of stem cell research should continue.

I definitely don’t think either of these articles indicates a shift towards a much more ASC friendly media, but they’re refreshing to see, nonetheless.

Stem Cell Therapy: A Process With a Promise

2011-10-10T17:14:00.000-07:00

Drew McUsic 10/10/11
xConomy Seattle

Stem cells hold the promise of ushering in a new era of regenerative medicine, as scientists and engineers have made significant progress in directing these powerful cells towards use in drug screening models and replacements for failing tissues. More recently, scientists have developed even more efficient and alternative methods for reprogramming cells into their desired state.

But as panelists at the recent Washington Biotechnology & Biomedical Association (WBBA) symposium on the “Today and Tomorrow” of stem cells in regenerative medicine emphasized, the stem cell promise is an exciting but risky wager that seems extreme even by biotech standards. It is easy, even for those familiar with the field, to understate the incredible challenges imperiling the transition of stem cell therapies to the clinic. Yet against all odds, two companies have pursued clinical trials and many more are fast at their heels. What gives? And what distinguishes this challenge from the commercialization of more traditional biotech approaches?

First, take the FDA. According to Joseph Gold, the senior director of neurobiology and cell therapies research at Menlo Park, CA-based Geron Corp. (NASDAQ: GERN) and a panelist at the WBBA event, the U.S. regulatory body was not really “conversant” in embryonic stem cell-derived therapies before Geron submitted its 20,000-page proposal for beginning clinical trials among patients with spinal cord injuries. This application to start trials was the largest of its kind ever presented. To date, there has only been one other company to seek FDA clearance to study an embryonic stem cell therapy in humans: Advanced Cell Technology (OTCBB: ACTC). Clearly playing a world role in the oversight of a constantly evolving landscape in biomedical technology, the FDA must understand and demonstrate competence in effectively regulating stem cell treatments for present and future companies to have a prayer of getting them to market. But Joe Gold argues that Geron’s and ACT’s application processes have improved, and in fact given birth to, the FDA’s ability to regulate stem cells as a new type of therapy.

Then comes funding, scaleup and manufacturing: requirements for any biotech but which may in the context of stem cell therapies point to a unique reliance on startups in pushing the field forward. Although preclinical stem cell research is well funded by the National Institutes of Health, federal dollars don’t support the costs of current good manufacturing practice (cGMP) manufacturing and clinical trials. And on the other end of the spectrum, Big Pharma appears hesitant to move forward with internal cell therapy programs because, like venture capitalists, they remain underwhelmingly convinced of the commercialization potential of such an infant scientific development. Pfizer, Bayer, Merck, and others have expressed interest and developed programs for partnering with cell therapy collaborators in academia and early-stage industry, but are not about to go it alone. This parallels the unfavorability of innovation within large pharmaceutical companies increasingly even in the space they know best-pharmaceuticals-where in the modern framework it’s preferable to acquire the next Viagra from what will likely be a small company. The small company environment can catalyze the initial phases of cell therapy translation better than anywhere else, partly because the level of infrastructure is right for tackling the nontrivial scale-up and manufacturing of cGMP cells, a proof-of concept endeavor that is impossible in the university discovery setting, but which, once demonstrated, can be augmented with acquisition by Big Pharma. The current state of affairs suggests, then, that the rate-limiting step for pushing stem cell treatments into mainstream use will be capital investment at the startup phase.

So why, in the midst of an extended recession and with hurdles raised higher on all fronts than those for new pharmaceuticals, is the field (albeit slowly) advancing? Even with a clear translational path, investors in some cases remain reluctant while conditions are favorable enough in others to get the ball rolling. What is happening? One possibility is that we are looking at the cusp of translation, which has happened time and again in biotech and which often gives rise to a similar teeter-tottering of a new wave of medical therapies over the edge into the clinic. John Mendlein, the executive chairman of Fate Therapeutics and also a panelist at the WBBA event, posited an apt reminiscence of the challenges facing the implementation of monoclonal antibodies as pharmaceuticals 20 years ago. Roadblocks stifling the technology, manufacturing, funding, and regulation scared every facet of the industry at the outset. The promise of the field prevailed, and what was a process became a profit. That’s what biotech is all about, and maybe this time is no different.

The Rebirth of Stem Cells

2011-10-03T16:50:00.000-07:00

Seema Singh, 09.26.11
Forbes India

Stephen Minger at GE is betting on cellular therapy to change the industry's thinking.

A decade after George Bush set the clock back for stem cell research, the science is showing signs of regeneration. Stem cells are mother cells that give rise to other cell types in the body. One of the more visible and vocal proponents of human embryonic stem cells (ES), Stephen Minger, says that the number of trials that are currently on suggests that the field is emerging from the shadow of skepticism and experimentation.

"When you see companies like Pfizer, GSK [GlaxoSmithKline], Johnson & Johnson and GE invest in stem cells and regenerative medicine, it suggests a level of maturity. It is still high risk, but it is a calculated risk," he says. Minger, who made the switch from a high-profile academician as director of the Stem Cell Biology Lab at Kings College, London, to the global head of Research & Development (R&D) for cell technologies at GE Healthcare, justifies his move as one for enabling cellular therapy. "I still do what I have done all my life--grow cells."

Indeed he is growing cells, not in a petri dish, but at an industrial scale that could one day supply zillions of stem cells to millions of people to repair diseased organs.

Minger grew up in Europe, studied in the U.S. and returned to the U.K. in 1996 to pursue stem cell research. The field didn't exist for the outside world then, he recalls. In the early 2000s, Minger's group was the first to deposit a human ES cell line into the U.K. stem cell bank. Today, at GE, he has large scale supplies of these cells which are being tested for a variety of applications.

Between 1994 and 2006, 45 and 37% of the drugs withdrawn from the market were due to cardio and liver toxicity respectively. The most recent casualty has been GSK's diabetes drug Avandia, which proved toxic to the heart after it hit the market. Minger suggests that both pharma companies and the U.S. FDA should test drugs on his new stem cell models for more accurate results. With his models, "you can tell early on whether this drug will cause problems in humans," he asserts. Chemists can then keep the parts that have produced the desired result and improve the defective part of the molecule, he points out.

Minger is screening dozens of molecules for a few drug companies including Genentech. Eventually, the industry may realize the value of investing in stem cell models rather than in expensive drug testing that fail at the later stage. But for now, Minger and GE are placing their bets on the encouraging results from studies on cellular therapy. This year, in August alone, two separate studies showed impressive improvements in patients with chemotherapy resistant blood cancer when they were injected with modified T-cells (protective blood cells in the body). In Europe, plans are afoot to undertake the largest ever clinical study on 3,000 cardiac patients.

So far, researchers around the world have used stem cells from different sources (human embryo, bone marrow, fat, skin) and followed different processes and protocols. However, with the European study on cardiac patients, the whole procedure will be standardized. "These are the kind of studies we should be doing for other diseases too," says Minger. And when that happens, not only will the demand for cells go up, their storage, analysis and imaging will also soar. It's no wonder then GE is investing big time in cellular technologies.

In India, Minger is crusading, as he has been in the U.K., for public banking of cord blood. If India and China could bank even 1% of their annual births, it could supply stem cells to the whole world, he says. But aren't India's resources limited? It is; which is why, he says, he is talking to some Indian trusts for support.

"My model is Devi Shetty [cardiac surgeon and promoter of Narayana Hrudalaya Hospitals], providing first world treatment at third world prices," he says. Minger has been visiting India regularly and is aware that "cellular therapy is not new here". "Balu [D. Balasubramanian, director of research at L.V. Prasad Eye Institute in Hyderabad] is my idol. His hospital has treated more than 3 million patients in five years, and mostly free," he says. Initially, though, the cost of cellular technology will be high, "we will bring it down," says Minger.

(For the rest of this article: Page 2

First trial of embryonic stem cell treatment in Europe gets green light

2011-09-27T13:10:00.000-07:00

Ian Sample, science correspondent
guardian.co.uk
Thursday 22 September 2011

Patients in Britain with an eye disease that leads to blindness will take part in Europe's first human embryonic stem cell trial.

British surgeons are to take part in the first trial in patients of a human embryonic stem cell therapy to gain approval from regulators in Europe.

Surgeons at Moorfields Eye Hospital in London will inject cells into the eyes of 12 patients with an incurable eye disease called Stargardt's macular dystrophy, one of the main causes of blindness in young people.

The clinical trial, designed to investigate the safety and tolerance of the groundbreaking therapy, is due to begin in December having received approval from the UK's Medicines and Healthcare products Regulatory Agency on Thursday. It is the first trial in people of a stem cell therapy to receive the go ahead from regulators in any European country.

Medical teams hope to slow, halt or even reverse the effects of the disease by injecting healthy retinal cells into the eye. The trial is controversial because the replacement retinal cells – known as RPE, or retinal pigment epithelial cells – are derived from human embryonic stem cells.

The Massachusetts-based company Advanced Cell Technology (ACT) announced the trial on Thursday. It will run alongside a similar study that began in July at the Jules Stein Eye Institute at the University of California, Los Angeles.

Only one patient has been treated so far in the US trial for Stargardt's disease. The results from both studies are expected next year.

Patients taking part in the UK trial will have between 50,000 and 200,000 cells injected behind the retina through a fine needle in an outpatient operation expected to take up to an hour. Only patients with advanced disease will be admitted to the trial.

Stargardt's disease is an inherited disorder that causes progressive vision loss through the thinning of retinal pigment epithelial cells at the centre of the retina, the region where the eye forms its sharpest images.

The loss of RPE cells usually begins between the ages of 10 and 20 years and leads to light-sensitive rods and cones in the eye dying off. This ultimately causes vision loss and even blindness.

If the treatment works, the replacement RPE cells will grow and eventually restore the retina to a healthy state that can support light-sensitive cells required for sight.

"This is a safety and tolerability study, so we are dealing with patients with advanced stage disease. Where we expect to get the most significant results is in earlier patients, before they have lost their photoreceptors. We're hoping to prevent the onset of blindness altogether in those patients," Robert Lanza, ACT's chief scientific officer, told the Guardian.

"The UK has been at the forefront of stem cell research in the past, but I think this confirms it is the leader in stem cell work in Europe. This is the first time an embryonic stem cell therapy has been approved in Europe," Lanza added.

"There is real potential that people with blinding disorders of the retina, including Stargardt disease and age-related macular degeneration, might benefit in the future from transplantation of retinal cells," said retinal surgeon James Bainbridge at Moorfields and the UCL Institute of Ophthalmology.

"The ability to regenerate retinal cells from stem cells in the laboratory has been a significant advance and the opportunity to help translate such technology into new treatments for patients is hugely exciting. Testing the safety of retinal cell transplantation in this clinical trial will be an important step towards achieving this aim," he said.

Last year, the US company Geron began a long-awaited trial of a stem-cell therapy to repair spinal cord injuries. Doctors hope that injecting stem cells directly into the spine will repair damaged nerve cells enough for paralysed people to regain some movement.

Peyton Manning Underwent Stem Cell Treatment For Neck Injury

2011-09-27T13:07:00.000-07:00

The Huffington Post
First Posted: 9/19/11

Indianapolis Colts quarterback Peyton Manning has reportedly undergone a stem cell treatment in Europe because of a neck injury that is so far this season keeping him off of the field and on the sidelines, according to news reports. Manning is currently suffering from a bulging disk in his neck; he has undergone surgery several times this year to correct the injury.

Manning's treatment is not approved in the United States, and involves using the four-time MVP's own fat cells to regenerate the nerves around his neck, AOL Sporting News reported.

The New York Daily News reported that Manning underwent another neck surgery after undergoing the stem cell treatment.

Athletes are allowed to undergo stem cell therapies "unless a banned substance is used as part of the procedure," an NFL spokesman told The Daily News.

Adult stem cells are able to grow and become a cell for a specific tissue or organ, according to the National Institutes of Health. They are different from embryonic stem cells, which come from fertilized eggs or aborted fetuses. Embryonic stem cells can turn into cells for nearly any tissue in the body.

Popular Science reported that Manning probably underwent a stem cell procedure involving induced pluripotent stem cells, which "can be reprogrammed to become any type of cell."

Manning's treatment is raising the eyebrows of some doctors, who say that the treatment doesn't have any scientific evidence to back it up, ABC News reported. There are also concerns about the message Manning is sending to the public, since people might go on to copy the procedure that might carry extra or unknown risks, according to ABC News.

"There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."

GOP presidential hopeful Rick Perry also recently underwent an experimental stem cell treatment with hopes of relieving a back problem, but doctors were concerned about that procedure as well, saying that the procedure could induce cancer or blood clots.

The Texas governor's procedure was "an unusual choice ... quite controversial because there isn’t good evidence yet, at least in the medical literature, that fat cells work better or even work at all in repairing bones," Cleveland Clinic orthopedic surgeon Dr. George Muschler told the AP.

Stem Cell From Human Tissue Equal To Embryonic Stem Cell

2011-09-19T19:49:00.000-07:00

ThirdAge.com
Posted by Claire Shefchik
September 13, 2011

A stem cell derived from a human embryo and a stem cell derived from adult tissue are virtually identical, a University of Wisconsin study found.

Lead researcher Joshua Coon, an associate professor of chemistry and biomolecular chemistry, told Medical News Today, "In...four embryonic stem cells and four IPS (Induced pluripotent) cells, the proteins turned out to be 99 percent similar. We looked at RNA, at proteins and at structures on the proteins that help regulate their activity and saw substantial similarity between the two stem-cell types."

Both types of stem cells have the ability to transform into any cell in the body and provide potential for cell and tissue replacement therapy for a wide variety of diseases, including diabetes, Parkinson’s and spinal cord injuries.

Induced pluripotent cells (IPS), since they are derived from the patient's own cells, they don't risk immune rejection, or carry the controversial aspect of cells derived from human embryos. However, until recently, scientists weren't sure they had equal traits.

Coon's team used mass spectrometry to analyze 6,000 different proteins in IPS cells, which had been reprogrammed to behave like embryonic cells.

“We applied very cutting-edge proteomic technologies to look at all the proteins or a very large percentage of them (in both types of cells) and we compared many cell lines, and what we found was that the protein levels are very similar in the two cell types,” he told the Wisconsin State Journal."

The study appeared online Sept. 11 in Nature Methods. Read it here: http://www.nature.com/nmeth/journal/vaop/ncurrent/full/nmeth.1699.html

Rick Perry Has Stem Cell Procedure, Then Works to Bring it to Texas

2011-09-14T14:52:00.000-07:00

The New York Tines
August 4, 2011, 7:24 pm
Wednesday, September 14, 2011
By SARAH MASLIN NIR

Gov. Rick Perry of Texas, a potential Republican presidential candidate, has for the past two months been working toward laying the groundwork for the commercialization of adult stem cell therapy, a highly controversial treatment which Mr. Perry underwent a month ago.

According to the story first reported by the Texas Tribune, in the month before Mr. Perry’s procedure, which was performed by Dr. Stanley Jones, a Houston-based orthopedist and a personal friend of the governor, a healthcare bill that authorized the creation of an adult stem cell bank was passed by Texas lawmakers.

And in the weeks since Perry’s stem cell infusion, the Texas Medical Board has held a stakeholder meeting — largely at the governor’s and Jones’ direction — to discuss how to regulate the procedure in Texas.

In addition:

Two days before last week’s Medical Board meeting, Perry sent a letter to the board chair espousing the economic and life-altering potential of adult stem cells and asking members to recognize “the sound science and good work that is already being done” as they consider new regulations.

On July 1, after having undergone the back procedure, Mr. Perry posted on Twitter that it “went as advertised,” the Texas Tribune reported.

But according to the Tribune,

The possible presidential contender didn’t reveal that he’d undergone an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success and can cost upwards of tens of thousands of dollars.

Dr. Jones, the Tribune reported, had never before performed the procedure.

But last year, Dr. Jones and his wife traveled to South Korea and Japan to obtain the same treatment for their own ailments. Dr. Jones told the Tribune his recovery led him to contact Mr. Perry. “I told him, I’m in Korea seeing miracles, and something needs to be done for our fellow Americans.”

The South Korean company that cultured Dr. Jones’ stem cells has since opened an affiliated lab outside of Houston. Mr. Perry’s stem cells were cultured in that Texas-based lab.

Rick Perry is against embryonic stem cell research, but he wants Texas to be center of stem cell advances

2011-09-14T14:49:00.000-07:00

chron.com

(Texas on the Potomac’s Perry Watch provides the most comprehensive coverage on the Internet of Texas Gov. Rick Perry’s presidential efforts. We are pleased to include some of the best content from the Texas Tribune’s Perry coverage, including this piece by Emily Ramshaw.)

Over the last two months, Rick Perry, a state representative with multiple sclerosis and the spine surgeon who performed the governor’s July 1 adult stem cell infusion have been laying the foundation for the commercialization of the controversial procedure in Texas.

In the month before Dr. Stanley Jones injected Perry with his own lab-grown stem cells during a spinal fusion — designed to speed recovery of the possible presidential hopeful’s back injury — lawmakers passed a health care bill that quietly authorized creation of a state adult stem cell bank. That amendment was added, with input from the governor’s office, by Rep. Rick Hardcastle, R-Vernon, who has MS and says he is about to start receiving stem cell infusions from Jones as part of a new human trial.

And in the weeks since Perry’s stem cell infusion, the Texas Medical Board has held a stakeholder meeting — largely at the governor’s and Jones’ direction — to discuss how to regulate the procedure in Texas. It’s pretty clear where Perry stands: Two days before last week’s Medical Board meeting, Perry sent a letter to the board chair espousing the economic and life-altering potential of adult stem cells and asking members to recognize “the sound science and good work that is already being done” as they consider new regulations.

Injecting patients with their own stem cells is a hotly debated practice: While some physicians swear by the procedure’s restorative properties, others argue it has little clinical evidence of success. The procedure has sparked a national debate over where doctors’ medical autonomy ends and FDA regulation begins.

Central to the debate in Texas is Jones, a Houston orthopedic surgeon and personal friend of both Perry’s and Hardcastle’s who believes he was cured of debilitating arthritis by having an infusion of his own stem cells in Japan. Jones is working, along with a Korean company best known for cloning dogs and marketing “stem cell cosmetics,” to launch the adult stem cell business in Texas.

A first step could be a stem cell bank. The amendment Hardcastle stuck onto an omnibus health care bill during June’s special session authorizes the state’s health and human services commissioner to establish an “autologous” adult stem cell bank — meaning a place for patients to store their own stem cells for future use.

Rick Perry wants Texas to lead the nation in stem cell research -- not to be confused with embryonic stem cell research. (AFP photo)

Hardcastle said the governor’s office didn’t ask him to carry it — as the only member of the Legislature with MS, he said, it’s been on his mind for “a long time” — but one of the governor’s staffers did advise him on it. Somewhat involved, Hardcastle said, was Jones, who has already removed some of Hardcastle’s stem cells to prepare them for re-injection.

A spokeswoman with the Health and Human Services Commission said the agency is in the very early stages of considering whether to create the stem cell bank. A few weeks ago, the agency received a letter from Houston Reps. Beverly Woolley, a Republican, and Senfronia Thompson, a Democrat, expressing their “serious concern” with the measure, for fear it might hinder the work of public and private scientists.

Meanwhile, Texas Medical Board spokeswoman Leigh Hopper said the regulatory agency held a stem cell stakeholder meeting last week — “at the governor’s behest, via Dr. Jones” — to start dialogue about adult stem cell treatments in Texas. The question? If Americans are — like Jones — increasingly flying all over the world to get promising stem cell treatments, shouldn’t Texas be a scientific and economic center for it?

Perry wrote as much in a letter he sent to Texas Medical Board president Irvin Zeitler Jr., two days before the stakeholder meeting, and three weeks after his own infusion.

“It is my hope that Texas will become the world’s leader in the research and use of adult stem cells,” he wrote.

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This article originally appeared in The Texas Tribune at http://www.texastribune.org/texas-people/rick-perry/perry-allies-lay-groundwork-tx-stem-cell-industry/.

Most in GOP field would scale back stem cell funding

2011-09-14T14:46:00.000-07:00

boston.com
The Boston Globe
By Tracy Jan
Globe Staff / August 7, 2011

WASHINGTON - Nearly all of the Republican presidential candidates would put the brakes on President Obama’s efforts to broaden federal spending on embryonic stem cell research, a move many scientists feel would jeopardize the future of a promising but controversial field that has been whipsawed by political shifts over the past decade.

The prospect of an about-face in White House policy alarms researchers, who in 2009 hailed Obama’s executive order to lift Bush-era restrictions on taxpayer support for this type of work as the end of the scientific Dark Ages. Last month, a federal judge dismissed a legal challenge to government funding for the experimentation.

Human embryonic stem cells have the ability to become any tissue in the body and might eventually lead to treatments for intractable diseases such as Parkinson’s, Alzheimer’s, and diabetes.

But antiabortion GOP candidates equate the emerging science with abortion because human embryos must be destroyed to extract the stem cells. And like President George W. Bush, who in 2001 barred the National Institutes of Health from supporting most embryonic stem cell research, they vow to restrict future funding for it.

Scientists in Massachusetts, where private philanthropy has enabled Harvard University to craft a majority of the embryonic stem cell lines used in research around the world and where a stem cell center in Shrewsbury is a mainstay of Governor Deval Patrick’s $1 billion life-sciences initiative, are warily eyeing the Republican slate. Researchers are painfully aware that the future of their work is caught up in a political tussle that could cast the field into scientific limbo.

“While many of us in the field end up raising private philanthropy to do the work, it is very important that labs have access to NIH dollars so more research can actually be done,’’ said Dr. Leonard Zon, director of the stem cell program at Children’s Hospital and founding president of the International Society for Stem Cell Research.

Since 2009, the NIH has released more than $300 million for research on human embryonic stem cells, provided the cells are derived from donated embryos that would otherwise be discarded from fertility clinics.

The presidential order has expanded the number of stem cell lines that federally funded scientists could use to 128, compared to the 21 Bush made an exception for because they existed prior to his 2001 ban.

Bush’s compromise drew sharp criticism from some conservatives, who chastised him for allowing any federal support of the research. Now most of the Republican candidates have refused to be pinned down as to just how far they will go in their opposition.

Wary of alienating social conservatives who have become increasingly important to winning in 2012, their campaigns responded to a Globe survey of their positions with vague statements and dodged questions about whether they would endorse Bush’s position of allowing funding for research on a limited number of existing stem cell lines to continue.

(To read the rest of this article click on the link in the title above.)

Rick Perry, prayer and stem cells

2011-09-14T14:25:00.000-07:00

The Economist
Aug 13th 2011 | AUSTIN | from the print edition

Unexpected consequences
Stem-cell research may be coming back onto the political agenda

For Christian conservatives, the biggest event on the summer calendar came on August 6th. Some 30,000 of the faithful gathered in a stadium in Houston for a prayer rally on behalf of the country. Some fasted, though others ate nachos. They were keen to see Rick Perry, the governor of Texas, who seems to be about to announce that he will run for president. The governor duly preached. “His agenda is not a political agenda—His agenda is a salvation agenda,” he said, of God.

The same could not be said of Mr Perry himself. He will enter the Republican race as a powerful prospect, partly because he is on firm footing with the party’s social conservatives. They might like him even more if they knew an obscure but intriguing fact about him: he actually practises what he preaches.
In this section

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Mr Perry, a young-looking 61, is a fitness fiend. Last year he made headlines when he shot a coyote while running in the hills west of Austin, Texas’s state capital. But time takes its toll. Last month Mr Perry had an operation to fix a recurring back problem. While the surgeon was at it, he injected the governor with stem cells, in an experimental procedure meant to speed recovery.

Pro-life conservatives oppose embryonic stem-cell research on the grounds that it destroys life. They are keen, however, on adult stem cells, which they hope may obviate the use of the embryonic kind. The stem cells used in Mr Perry’s procedure were his own. And the governor has been a proponent of adult stem-cell research, for economic reasons as well as ethical ones. If such treatments gain federal approval, and become more popular, Texas could be a centre of that industry.

Mr Perry’s experiment may draw new attention to the issue. Opposition to embryonic stem-cell research has been somewhat subdued since the last presidential election; but it has never gone away. In 2001 George Bush issued a ban on federal funding of research on new embryonic stem-cell lines—a compromise that meant that scientists could only work with cells from the batches they already had. When Barack Obama took office he promptly overturned the ban. Funding has rushed back to such research, and the United States now has 128 stem-cell lines, up from just 21 in 2009.

Critics have continued to complain about this use of federal money; on July 27th a judge dismissed another lawsuit on the subject. They may find more sympathy as the election heats up. None of the Republican front-runners supports expanded funding for embryonic stem-cell research. Mitt Romney was broadly in favour of it when he was the governor of Massachusetts, where much stem-cell research is done, but he changed his mind (again).

It would be a shame if federal funding were to be withdrawn. In March, for example, researchers at Northwestern University in Illinois announced that they had turned a stem cell into a neurone—one of the types that are affected by the progression of Alzheimer’s disease.

from the print edition | United States

Scientists discover an answer to stem cell therapy’s lethal side effects

2011-09-14T14:22:00.000-07:00

io9

In the emerging field of regenerative medicine, some of the most promising developments revolve around so called "pluripotent cells" — cells like embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSC) that can develop into just about any type of cell in your body.

Unfortunately, the differentiating potential that makes pluripotent cells like these so promising can also render them lethal. Now a team of research scientists has found a way to keep the potentially deadly side effects of stem cell therapy in check.

Pluripotent cells, when placed in the right environment, can be "told" by scientists to differentiate into any number of tissues. Why is this useful? Let's say a burn victim is in need of a skin graft, but the burn is so serious that he lacks the donor tissue necessary for such a procedure. Stem cells can be coaxed into developing into skin cells that can be transplanted to treat the victim's burns. But there is also an inherent risk to this procedure.

If any of the stem cells remain undifferentiated — i.e. any of the stem cells fail to develop into skin cells prior to transplantation — they can turn into dangerous tumors known as teratomas instead.

"Commonly used differentiation protocols for embryonic stem and iPS cells often give rise to mixed cultures of cells," said Dr. Micha Drukker, senior author of the research team's paper, published in this week's issue of Nature. "Because even a single undifferentiated cell harbors the ability to become a teratoma, we sought to develop a way to remove these cells before transplantation."

Until recently, there was little that could be done to identify these undifferentiated stem cells prior to transplantation, but now Drukker's team of Stanford researchers has developed an antibody that is capable of doing just that.

As a cell differentiates, the landscape of its surface changes with it. When an embryonic stem cell develops into another cell type, for example, specific "landmarks" on its exterior will emerge, while other landmarks will cease to exist. By growing a number of antibodies targeted against undifferentiated stem cells, the researchers were able to identify not just which antibodies were the best at seeking out the undifferentiated stem cells, but which of the cells' "landmarks" the antibodies were actually being attracted to. The researchers called these stem cell—specific landmarks "pluripotency surface markers," or PSMs.

One of the antibodies produced allowed the researchers to identify a PSM that they named the "H type-1 glycan." The glycan was found on the majority of stem cells investigated, but only those that had yet to differentiate. The researchers named the antibody that was attracted to the glycan PSM "anti-stage-specific embryonic antigen 5," or anti-SSEA-5, for short.

While other PSMs and their corresponding antibodies were also identified, none were as effective at identifying undifferentiated stem cells as anti-SSEA-5. However, by targeting the stem cells with anti-SSEA-5 along with two other anti-PSMs, the researchers were able to completely separate the undifferentiated cells from the differentiated ones.

In other words, scientists would now appear to have the ability to not only identify but eliminate all non-differentiated (and therefore dangerous) stem cells from a batch of otherwise very useful cells. In doing so, they've overcome one of stem cell therapy's biggest hurdles, and paved the way for the future implementation of groundbreaking stem cell treatments.

Via Nature

New stem cell study a first

2011-09-12T13:36:00.000-07:00

SAMARA KALK DERBY | skalk@madison.com derby

A study released Sunday shows embryonic stem cells and induced pluripotent stem cells are almost identical.

Since human IPS cells were first produced from mouse cells in 2006 and from human cells in 2007, it has been thought they were equivalent to embryonic stem cells, which are controversial because they are derived from human embryos.

But new research, directed by Josh Coon, a UW-Madison associate professor of chemistry and biomolecular chemistry, shows the proteins in the two types of cells are almost identical.

Stem cells have the ability to develop into any of the different types of cells in the body. In many tissues they serve as a sort of internal repair system, dividing to replenish other cells.

Research into stem cells is considered critical to finding cures for many diseases, including diabetes, Parkinson’s and spinal cord injuries.

UW-Madison stem cell researcher Jamie Thomson became the first person to isolate human embryonic stem cells in 1998.

Coon’s study, published online in Nature Methods, aimed to compare most of the proteins present in the embryonic stem cells and the IPS cells, which have been reprogrammed to function like embryonic stem cells.

New technologies have allowed studies in the past couple of years to show the two types of stem cells to be similar, but nobody has had the ability to look at the proteins, the molecules that do most of the biological functions, Coon said.

“In this study, we applied very cutting edge proteomic technologies to look at all the proteins or a very large percentage of them (in both types of cells) and we compared many cell lines, and what we found was that the protein levels are very similar in the two cell types,” he said.

Coon, whose lab did the research in collaboration with Thompson’s lab, said there is less than a 1 percent difference in the proteins between one cell type and the other.

His study is the first to show that at the protein level.

Copyright 2011 madison.com. All rights reserved.

Slaughter-Free Stem Cell Meat Sausage Coming Soon

2011-09-05T16:08:00.000-07:00

Published September 01, 2011
Fox News | NewsCore

MAASTRICHT, The Netherlands -- Scientists are on the verge of growing artificial meat in laboratories without the need for animal slaughter, according to a report cited Thursday by The Herald Sun -- with one expert predicting a stem cell sausage might be just six months away.

Researchers say the advent of "pain-free" meat produced from stem cells could save millions of animals from the abattoir and help the environment through substantially reduced energy, land and water use.

Dutch researcher Dr. Mark Post, of Maastricht University, predicts the first synthetic sausage could be just six months away.

"I'm hopeful we can have a hamburger in a year," he told New Scientist.

But a major stumbling block will be turning cultured meat into a tasty, textured and nutritious option that could make mouths water in supermarkets and restaurants. The time and cost involved are also major hurdles.

Post said the meat -- pig cells fed with horse fetal serum -- he had grown did not look appetizing because it was white.

"It's white because there's no blood in it, and very little myoglobin, the iron-bearing protein," he said. "We are looking at ways to build up the myoglobin content to give it color."

Farmers do not feel threatened by the new technology, according to the Herald Sun. A Cattle Council of Australia spokesman said the development would not threaten farmers given the difficulty in creating a protein-rich substance, and the sheer amount that would need to be produced.

(For the rest of this article please click on the link in the title above.)

Study about U.S. attitudes toward human embryonic stem cell research

2011-06-30T09:30:00.000-07:00

Most Americans trust their own judgment on the subject more than their churches or other authorities

While research using human embryonic stem cells has roused political controversy for almost two decades, little has been done to scientifically assess American attitudes on the subject. New research from the University of Nevada, Reno provides decision-makers with a much clearer picture of how their constituents truly feel about the subject.

The study, "U.S. attitudes toward human embryonic stem cell research," published this month in the journal, Nature Biotechnology, was conducted by University of Nevada, Reno faculty members Mariah Evans (lead author) and Jonathan Kelley, who surveyed a large, representative national sample of 2,295 respondents in 2009. Their most significant findings include:

More than two-thirds of respondents approved of using therapeutic cloning (nuclear transfer of the patient's own genes) and stem cells from in vitro fertilized embryos to cure cancer or treat heart attacks, while only about one in six respondents did not approve. Therapeutic cloning remains banned in the United States today. About one in six respondents had mixed feelings or was undecided.

Over two-thirds of respondents also approved of a newer, less-researched method - using modified adult cells as an alternative to using cells from in vitro fertilized embryos - if the use could cure cancer or treat heart attacks. Less than 15 percent did not approve. About one in five had mixed feelings or was undecided.

Almost half (43 to 47 percent) of respondents also approve of use of therapeutic cloning, stem cells from in vitro fertilized embryos and stem cells from an adult to treat allergies, but slightly over one in four do not. And, 28 to 29 percent have mixed feelings or undecided in this regard. These findings indicate that while more respondents approve of the use of these methods for treatment of less-serious conditions than disapprove of it, the approval is not as strong as it is for using these methods to treat more serious conditions and diseases, such as cancer or heart attacks.

Respondents were not as approving of use of these methods for cosmetic purposes, such as creating new skin to restore someone's youthful appearance. Almost one-half (45 to 50 percent) disapproved of this use, while only slightly more than one-quarter (25 to 29 percent) approved of this use. About one-quarter had mixed feelings or were undecided.

Respondents did not support human reproductive cloning, neither of themselves nor of a child who died, with almost three-quarters (71 to 73 percent) disapproving and only about one in 10 approving. About one in five had mixed feelings or was undecided.

Respondents were quite evenly divided in their thoughts on animal cloning with slightly over a third approving, slightly over a third disapproving, and about one-quarter having mixed feelings or being undecided.

Evans, a sociologist, also found it interesting that the majority of respondents trusted their own judgment most when deciding on their approval or disapproval on stem cell research issues, rather than looking to their church or other authorities, such as governmental ethics committees.

"The vast majority, over two-thirds, said that in deciding whether it is right to allow these treatments, they would follow their own judgment," she said. "Only 4 percent gave greater moral weight to the Catholic Church than to themselves, and even among committed church-going Catholics, only about one in five defer to the church on these matters."

The study also revealed that despite the Catholic Church's firm opposition, support for the use of stem cell research for the cure or treatment of serious diseases was almost as strong among Catholic laity as among Protestants. Even those in the most disapproving demographic group, churchgoing fundamentalist women, were still more in favor than opposed.

Source: University of Nevada, Reno

Arch Biopartners Enters Agreement to Develop Prototype Diagnostic Imaging Agents for Brain Tumor Stem Cells

2011-06-27T09:58:00.000-07:00

TORONTO, ONTARIO--(Marketwire - June 27, 2011) - Arch Biopartners Inc ("Arch" or the "Company") (CNSX:ACH)(OTC:FOIFF) and its subsidiary Arch Cancer Therapeutics ("ACT") today announced ACT has entered into an Agreement for Research Services (the "Agreement") with the National Research Council of Canada (NRC). Under the agreement, the NRC will combine ACT's brain tumor initiating cell (BTIC)-targeting peptide technology with paramagnetic nanoparticles to develop prototype BTIC diagnostic imaging agents for use in magnetic resonance imaging ("MRI").

BTICs are a cancer stem cell population that represent a significant disease reservoir believed to play an important role in the formation and recurrence of malignant glioma in humans. BTICs are not detected by current medical diagnostic imaging technologies.

Paramagnetic nanoparticles are small injectable particles used for molecular imaging and can be visualized by MRI. It is anticipated the combination of ACT's BTIC targeting peptides and paramagnetic nanoparticles will for the first time make BTICs visible.

It is expected that this development contract, including animal in vivo testing, will be completed within nine months, and if successful, will further validate ACT's BTIC-targeting technology as a potential diagnostic tool for human malignant glioma.

About Arch Cancer Therapeutics

ACT is an Alberta corporation wholly owned by Arch Biopartners. ACT's objective is to develop non-invasive diagnostic and therapeutic molecules for brain cancer utilizing new and innovative approaches.

Despite intensive research over the past 30 years, clinical outcomes for patients with malignant glioma have not changed substantially with average survival rates remaining at a dismal 12-15 months. ACT's proprietary molecules are specialized peptides that identify and target brain tumor initiating cells ("BTIC") and invasive brain cancer cells, two disease reservoirs that are not normally seen using current state of the art diagnostic imaging techniques.

About Arch Biopartners

Arch Biopartners is a portfolio based biotechnology company established to developing early stage proprietary technology for sale to pharmaceutical and industrial companies.

The Company's website address is: www.archbiopartners.com.

For more information on the Company, please consult the other public documents filed on SEDAR at www.sedar.com.

Forward-Looking Statements

All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management's estimates or opinions change.

The CNSX has not reviewed and does not accept responsibility for the adequacy of this release.

Embryonic Stem-Cell Funding Challenge Should Be Dismissed, U.S. Says

2011-06-26T19:32:00.001-07:00

By Tom Schoenberg - Jun 24, 2011 3:06 PM PT

A challenge to funding of human embryonic stem-cell studies should be dismissed after an appeals court found the government-backed research to be lawful, the Obama administration said.

The Justice Department in a filing today urged U.S. District Judge Royce Lamberth to end a lawsuit that seeks to block the U.S. Health and Human Services Department and the National Institutes of Health from spending federal funds on researching human embryonic stem-cells, known as hESC.

Last year, Lamberth temporarily barred U.S. agencies from funding human embryonic research, finding it likely violated a 1996 law called the Dickey-Wicker Amendment. The law prevents the government from spending money on research where a human embryo is damaged or destroyed.

The U.S. Appeals Court in Washington in a 2-1 ruling in April said the funding may continue while Lamberth considered the merits of a challenge filed by two doctors.

“The court of appeals has conclusively resolved the primary claim that plaintiffs have advanced in this case,” the U.S. said in today’s filing. “The court held that Dickey-Wicker is ambiguous, and that NIH reasonably read the statute to permit funding of hESC research but to forbid funding for the derivation of hESCs.”

The doctors who brought the lawsuit asked Lamberth again today to block the funding, arguing that the appeals court only considered one of their arguments.
‘Risk of Injury’

“Each time grant-awarding officials and federally funded scientists support or engage in hESC research, they ‘knowingly subject’ human embryos to ‘risk of injury or death’ in violation of Dickey-Wicker,” the doctors said in their filing.

In fiscal 2010, NIH spent about $200 million to fund more than 200 human embryo research grants, the Justice Department and the institutes’ director, Francis Collins, said in court papers.

Embryonic stem cells can grow into any of the 200 types of cells in the human body. Scientists say these cells have the potential to be used for repairing cells damaged by injury or disease.

President Barack Obama in March 2009 opened up government funding for the study of embryonic stem cells when he reversed an executive order of his predecessor, George W. Bush, limiting research to about 20 existing lines of the cells.
NIH Guidelines

In response to Obama’s order, the NIH wrote guidelines allowing research on cells derived from embryos that would otherwise be disposed of following in vitro fertilization procedures.

James Sherley, a researcher at Boston Biomedical Research Institute, and Theresa Deisher of Seattle won the right to sue by claiming they were unfairly disadvantaged in competing for NIH funding with researchers who used embryonic cells.

The government said the stem-cell research is separate from any that destroys the embryo because the cells must be grown in a medium and are then “differentiated” into other cells, such as nerve cells.

The appeals court agreed with the government’s contention that because the Dickey-Wicker Amendment is written in the present tense the “statute strongly suggests it does not extend to past actions.”
‘Linguistic Jujitsu’

In a dissenting opinion, Judge Karen LeCraft Henderson accused her colleagues on the three judge panel of “linguistic jujitsu” in parsing verb tenses in order to narrow the amendment’s meaning from what Congress intended.

The plaintiffs’ challenge is likely to succeed because the amendment prohibits federal funding of embryonic stem cell research “in all of its sequences,” LeCraft Henderson wrote.

Since 2002, the government has spent $546 million on human embryo research, Collins wrote in an Aug. 31 court filing. If the ban were upheld, Collins said, it would result in the loss of more than 1,300 full-time or part-time jobs, as well as “the potential loss of top U.S. scientific talent as lead scientists may be forced to move to other countries to pursue their cutting-edge research.”

Stem-cell researchers are seeking cures for illnesses such as Parkinson’s disease, spinal cord injuries, and genetic conditions. Embryonic stem cells can grow into any kind of tissue and may have the potential to accelerate a range of research.

The original case is Sherley v. Sebelius, 1:09-cv-01575, U.S. District Court, District of Columbia (Washington). The appeal case is Sherley v. Sebelius, 10-5287, U.S. Court of Appeals for the District of Columbia Circuit (Washington).

To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net;

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

Self-Renewing Neural Stem Cells Created At UCSD

2011-04-27T14:12:00.000-07:00

Scientists at the UC San Diego have made groundbreaking advancements in neural stem cell research which may change the future for patients with vision problems to those with Parkinson's disease.

Dr. Kang Zhang, who is a physician and also holds a doctorate in his field, and his team of 30 have created self-renewable neural stem cells which are capable of producing large quantities – millions of cells in less than a week – that can be used in clinical trials."To my knowledge, this is the first time someone has actually able to achieve that," said Zhang, who is a professor of ophthalmology and human genetics at Shiley Eye Center and director of the Institute for Genomic Medicine at UC San Diego.

"In the past, neural stem cells could be produced in large quantities, but those cells had a tendency to form tumors in the body. The trick is to harness the potential of those stem cells to generate different tissues or neurons in this case, however eliminating or minimize its risk of forming tumors," said Zhang.

According to Zhang, two years ago, 40 mice were injected with stem cells at the laboratory.

Six months later, all 40 mice developed some sort of tumor.

But after using the research from UC San Diego, 40 additional mice were recently injected with stem cells. Now, six months and even a year later, none of the mice developed a single tumor.

While the stem cell research has been specific to vision loss, in the future, the same technology may be used in those with neurodegenerative diseases such as Parkinson's disease."

We could also generate motor neurons which are lost in spinal chord injury," said Zhang.

Zhang and his team are moving into the next stages of their work, including clinical trials perhaps in the next two years.

Stem cell regulations shouldn't stifle research: Indian experts

2011-04-21T02:45:00.001-07:00

Bhubaneswar, April 21 : India is mulling measures to regulate research in the therapeutic use of human embryonic stem cells - a field that offers promise for curing brain, nerve and spinal cord diseases, among others. But experts say the regulations should not be very harsh or affect ongoing work in the field.

A 12-member national apex committee set up last year by the union health ministry to oversee and monitor the activities, especially to check misuse of stem cells, held its first meeting at the end of last year but has not got too far in its work.

"It was just the beginning. We are discussing all the issues and chalking out our future plans," a member of the committee, who did not want to be identified, told IANS, adding the panel may take several months to come out with something concrete.

The panel led by Alok Srivastava, a haematologist at the Christian Medical College (CMC), Vellore, was formed a few years after the government published guidelines on stem cell research in 2007. The guidelines, however, have no power to curb stem cell therapy and researches conducted allegedly without proper procedures.

While experts also feel there have to be rules in place to prevent misuse of stem cells, some of them suggest regulations should not be harsh if India wants growth in the area.

"If the old guidelines are enforced in its present form, then many experts might have to conduct clinical trials, including pre-clinical (on animals) again, to test the efficacy of a therapy, which has been used for treating hundreds of patients," an expert said.

Geeta Shroff, a stem cell expert who claimed to have successfully provided a cure to over 800 patients at her Nu Tech Mediworld at Delhi, told IANS she does not oppose the proposed regulations.

"But they shouldn't curb research. The law has to be such that the work does not stop," she said.

Shroff said she has been treating hundreds of patients, including many from abroad, with stem cell therapy for conditions like Parkinson's disease, diabetes, eye disorders, cardiac conditions, spinal injuries and post-stroke conditions over the past nine years.

"Not one has reported any side effects," she said. Shroff said 30 percent of her patients are physicians or have family members who are highly educated medical professionals.

Stem cell research has become a controversial topic in the past few years across the world with some favouring its use of embryonic stem cell and others opposing it on moral and ethical grounds.

However, its exponents have not faced any problem in India, although several countries do not allow the manipulation or destruction of human embryos.

Satish Totey, secretary of the Stem Cell Research Forum of India (SCRFI), said the guidelines published in 2007 are nothing and the country needs tighter regulations.

Embryonic stem cells are cells derived from an early stage of an unborn baby that is less developed than a foetus, and the treatment involves the replacement of a layer of degenerated cells with new cells created using embryonic stem cells.

The therapy offer promises for the people suffering from neurological diseases - disorders affecting the brain, spinal cord and nerves. The diseases affect about one billon people and kill an estimated 6.8 million every year in the world.

Stem cells offer the possibility of a renewable source of replacement cells and tissues to treat a myriad of diseases, conditions and disabilities, including Parkinson's disease, sclerosis, spinal cord injury, burns, heart disease, diabetes, eye disorders and arthritis.

--IANS

Embryonic Stem Cell Research Under Attack but Still Showing Success

2011-03-21T16:19:00.000-07:00

March 21, 2011 09:20 AM EDT
gather NEWS

Even though the house just passed a bill banning its research in some states, embryonic stem cell research is still prevailing and showing the medical miracles that come from it. This hot topic of debate remains a taboo issue to some people, but to scientists who are studying it, it's becoming something of an amazing area of science.

Recently, a bill passed through Minnesota House and Senate that criminalizes embryonic stem cell research. Basically, the intent of this bill, which passed, is to prevent human cloning. Okay, fair enough if you want to get right down to the literal basis of the topic, but these techniques used by researchers are meant to help people with severe conditions and injuries.

Good news for those who support embryonic stem cell research came today when researchers in New York were rewarded with $500,000.00 for pioneering work in human stem cells. This award granted to three researchers is the largest award granted in the medical and science fields in US history.

Thankfully, not all states are criminalizing stem cell research, as it may very well be the future of medical science. Stem cells are useful and amazing because they can become any part of the body. Scientists have already formed new vital organs using stem cell research, which can potentially be used in transplants, among many other applications.

Heart Damage Improves, Reverses After Stem Cell Injections In A Preliminary Human Trial

2011-03-19T20:21:00.000-07:00

Posted on: Friday, 18 March 2011, 14:29 CDTredOrbit

Researchers have shown for the first time that stem cells injected into enlarged hearts reduced heart size, reduced scar tissue and improved function to injured heart areas, according to a small trial published in Circulation Research: Journal of the American Heart Association.

Researchers said that while this research is in the early stages, the findings are promising for the more than five million Americans who have enlarged hearts due to damage sustained from heart attacks. These patients can suffer premature death, have major disability and experience frequent hospitalizations. Options for treatment are limited to lifelong medications and major medical interventions, such as heart transplantation, according to Joshua M. Hare, M.D., the study's senior author and professor of medicine and director of the Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, University of Miami in Miami, Fla.

Using catheters, researchers injected stem cells derived from the patient's own bone marrow into the hearts of eight men (average age 57) with chronically enlarged, low-functioning hearts.

"The injections first improved function in the damaged area of the heart and then led to a reduction in the size of the heart. This was associated with a reduction in scar size. The effects lasted for a year after the injections, which was the full duration of the study," Hare said.

Specifically, researchers found:

* Heart size decreased an average of 15 percent to 20 percent, which is about three times what is possible with current medical therapies.
* Scar tissue decreased by an average of 18.3 percent.
* And there was dramatic improvement in the function, or contraction, of specific heart areas that were damaged.

"This therapy improved even old cardiac injuries," Hare said. "Some of the patients had damage to their hearts from heart attacks as long as 11 years before treatment."

The researchers had used two different types of bone marrow stem cells in their study — mononuclear or mesenchymal stem cells. The study lacked the power to determine if one type of cell works better than the other. All patients in the study benefited from the therapy and tolerated the injections with no serious adverse events.

Hare's study assessed the effect of stem cell injections differently from other studies of post-heart attack stem cell treatment. His team measured contractility, scar size and structural changes of the heart.

"Studies of bone marrow cell therapy for ischemic heart disease in animals have shown improved ejection fraction (the amount of blood the heart can pump). However, this measurement has not reliably translated to early phase studies in humans," Hare said. "Ejection fraction may not be the best way to measure the success of stem cell therapy in the human heart."

Hare also said their findings suggest that patients' quality of life could improve as the result of this therapy because the heart is a more normal size and is better functioning. "But, we have yet to prove this clinical benefit – this is an experimental therapy in phase one studies. These findings support further clinical trials and give us hope that we can help people with enlarged hearts."

Look, no embryos! The future of ethical stem cells

2011-03-14T17:48:00.000-07:00

For years, ethical issues hampered progress in stem cell research. Now, experts believe that developments in reprogrammed 'iPS' cells will truly revolutionise the treatment of life-threatening illnesses.

Alok Jha

The Observer

Sunday 13 March 2011

It is unclear at exactly what point the phrase "stem cell" entered the vernacular, one of very few scientific terms that achieve the status of, say, DNA in not requiring a detailed explanation every time it is written down or spoken.

Whether or not you know exactly what they are or what they do, stem cells imply something very specific: in them is invested the next generation of medicine, revolutionary treatments for everything from Parkinson's to Alzheimer's. On the horizon, there is also the hope of growing genetically matched tissue (even whole organs) to replace anything that has been damaged by disease or accident.

But perhaps the reason stem cells managed to lodge themselves so deep in the public psyche was not just because of their awesome scientific potential, or their ability to turn into the treatments of the future. Perhaps it was politics. For years, stem cells dominated all other science stories in newspaper headlines because they framed an ethical conundrum – to get to the most versatile stem cells meant destroying human embryos.

Research on stem cells became a political football, leading to delays in funding for scientists, particularly in the US. Not that the work itself was straightforward – the process of extracting stem cells from embryos is difficult and there is a very limited supply of material. Inevitable disappointment followed the years of headlines – where were the promised treatments? Was it all over-hyped?

For Paul Fairchild, co-director of the newly founded Oxford Stem Cell Institute, disappointment is just not on the agenda. Over a coffee in the University of Oxford's pathology department, where he is a professor, he explains his vision for the coming, post-hype decade of stem cell science.

"It's an exciting time in stem cell biology for a host of reasons," he says. "We've entered a whole new phase in the stem cell field, which has been held up enormously by ethical issues for over a decade."

Key to this is the discovery, in the past few years, of a way to make stem cells that do not require the destruction of embryos. In one move, these induced pluripotent stem (iPS) cells remove the ethical roadblocks faced by embryonic stem cells and, because they are so much easier to make, give scientists an inexhaustible supply of material, bringing them ever closer to those hoped-for treatments.
Fairchild says that iPS technology will "completely revolutionise the whole of medicine this century".

And the talk is matched by action: the Oxford Stem Cell Institute is a recognition of the importance of the work ahead, a collaboration that brings together 37 laboratories across 17 departments at the university. "It's an attempt to try and bring all of the work in stem cell biology under one umbrella organisation to allow people to collaborate more effectively."

Stem cells are the body's master cells, the raw material from which we are built. Unlike normal body cells, they can reproduce an indefinite number of times and, when prodded in the right way, can turn themselves into any type of cell in the body. The most versatile stem cells are those found in the embryo at just a few days old – this ball of a few dozen embryonic stem (ES) cells eventually goes on to form everything that makes up a person.

In 1998, James Thomson at the University of Wisconsin-Madison announced that he had isolated human ES cells in the lab. Finally, these powerful cells were within the grasp of scientists to experiment with, understand and develop into fixes for the things that go wrong.

There were some immediate practical problems with the work. Once scientists had extracted ES cells from an embryo, they could create an immortal line of the cells to use in research. But the wide genetic variations in humans mean that scientists need lots of different lines of ES cells to treat and understand the wide variety of faults. Each new line of ES cells can only be created by fertilising an egg, and these are a precious, rare commodity.

This is also where the ethical problems lie. Extracting ES cells destroys the embryo – for some, this is akin to killing a potential human life. George W Bush banned the use of federal dollars to support research using human ES cells on all but a limited number of cell lines that already existed in research labs prior to August 2001. Barack Obama reversed that ban, only to be thwarted by a federal court ruling in 2010 that, once again, put the scientists into a state of uncertainty. By contrast, the UK laws are relatively civil – after much debate about the ethics of using human embryos, the government passed strict, but fair, laws that allowed ES research to go ahead.

But that did not get rid of the practical problems of a lack of donor eggs, or that the experiments with ES cells as treatments – to repair a damaged heart, for instance – were proving unsuccessful.

Enter the iPS cell. In 2007, Shinya Yamanaka at Kyoto University in Japan demonstrated a way of producing ES-like cells without using eggs. He took a skin cell and, using a virus, inserted four specific bits of DNA into the skin cell's nucleus. The skin cell incorporated the genetic material and was regressed into an ES-like cell – it had been "reprogrammed" using a batch of chemicals in the lab. In a few short experiments, scientists had a near-limitless supply of stem cells that were, seemingly, as good as ES cells for their research.

By creating iPS cells from patients with genetic diseases, scientists have been able to watch which genes go wrong in a variety of conditions, how and when it happens – all of it critical detail in finding ways to stop diseases in their tracks.

The method works like this: take some skin cells from a person with Parkinson's disease and then regress these back into iPS cells. Then coax these stem cells to turn into neurons and watch how they work and, crucially, how they go wrong. These neurons are genetically identical to the patient's own brain cells – allowing scientists to model the disease more accurately and test out ideas or even screen potential drugs.

"It's possible now, of course, to take a few cells from an individual with an intractable disease of some kind for which there are no animal models or any way of studying it, to reprogramme them to an iPS cell state and then differentiate from those the cell type that's affected from the disease," says Fairchild. "We now have a way of taking them from that person and studying the cell type itself in vitro that will almost certainly have symptoms of the disease. It's possible to produce these models of human disease in vitro which we've never had access to before."

Models using iPS cells have proliferated in a few short years: they are now available for, among other things, motor neurone disease, juvenile diabetes and sickle cell anaemia.

"It's exciting to have models that we can now probe and find out what is actually going on for the first time," says Fairchild. Traditionally, scientists use animal models of disease in order to carry out experiments or test brand new drugs – but these models are not perfect. Using human cells taken from a patient with a human disease is a more promising way of gauging what might happen in people.
Fairchild has been examining how to use iPS cells to modulate the body's immune system. It is a route, he hopes, to less rejection when people get transplants of replacement tissue. The same techniques could even develop into a better way to treat cancer.

He started by differentiating embryonic stem cells into a key part of the body's immune system called dendritic cells. These cells continually sample proteins, called antigens, that sit on the surface of everything in the body. If they determine that the antigen comes from something potentially dangerous or foreign, they set the body's killer T-cells to go after the danger and destroy it. On the flip side, the dendritic cells can also dial down the ferocity of the killer T-cells if they recognise an antigen as non-foreign.

One way Fairchild's team is using this idea is to grow dendritic cells that can recognise the antigens on tumours. Inserting these cells into a patient would dial up the immune system's natural response to that tumour. "What you do is grow the dendritic cells, then feed them with the tumour-associated antigens in vitro," he says. "Then put those back into the patient, so that they're presenting those melanoma antigens."

His experiments have shown that the dendritic cells do indeed stimulate the body's T-cells to respond robustly. The T-cells are then programmed to find the tumour and destroy it. That means a better natural response to cancer, all without the need for toxic chemotherapy.

Another way to use the dendritic cells is to dial down the body's immune response to transplanted tissue or organs. Anyone who has a transplant needs immunosuppressant drugs for the rest of their lives to prevent their immune systems from attacking the new tissue. Stem cells offer the possibility of growing genetically matched tissue for patients, so rejection should, in theory, not be a problem.
But Fairchild points out that growing matched tissue for every individual is likely to be prohibitively expensive for now. Instead, scientists would probably grow replacements from a bank of stem cells that are close matches to the majority of the population. But that means that replacement tissue would still provoke the recipient's immune system.

Fairchild's solution is to grow dendritic cells from the same stem cells being used to grow the replacement tissue for the patient. The dendritic cells can then be used to train the recipient's immune system that the replacement tissue is not to be rejected.

The creativity in the field is exciting, but it is right, also, to point out the many technical issues facing iPS cells in moving outside the lab. Just recently, Andras Nagy of Mount Sinai hospital and Timo Otonkoski at the University of Helsinki found genetic abnormalities when creating iPS cells. In a study published in Nature, they reported the deletion or amplification of certain strands of DNA. "Our analysis shows that these genetic changes are a result of the reprogramming process itself, which raises the concern that the resultant cell lines are mutant or defective," said Nagy.

It is just one of a number of research papers raising concerns about the way iPS cells are produced. "In a laboratory dish, pluripotent stem cells promise to become any sort of cell a researcher could want," wrote Monya Baker, editor of Nature Reports Stem Cells, in a 2009 article looking to the future of the iPS technology. "But when transplanted into the body, such cells could grow unpredictably: clinicians worry most about tumour formation, although one can imagine other dangers, such as tissues growing in the wrong place."

The very things that make iPS cells so useful in lab situations – their immortality and versatility – would be disastrous if left unchecked inside people. But, for a field that is barely a few years old, the remarkable pace of achievement should give plenty of hope that these challenges will be met. "Turning knowledge into medicine is never easy," says Baker. "But the pace of knowledge generation itself is fast and furious."

MarketsandMarkets: Global Stem Cell and Advanced Technologies Market Worth US$ 88.3 Billion By 2014

2011-03-12T15:10:00.000-08:00

WILMINGTON, Delaware, November 3 /PRNewswire/ -- The new market research report, 'Global Stem Cell and Advanced Technologies Market' (2009 - 2014)', published by MarketsandMarkets (http://www.marketsandmarkets.com) analyzes the major trends in the global stem cell market. It identifies and analyzes the main market drivers, restraints, and opportunities for the various products, services, technologies, and applications submarkets in different geographic regions.
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The stem cell market is growing rapidly due to increasing regulatory approval and public acceptance bodies. The benefits of stem cell therapy are attracting an increasing number of patients. The product submarket for human and embryo stem cells are expected to drive the growth of the overall market. In addition, intensive R&D efforts and the increasing investments into research on stem cells therapy are soon expected to improve the efficacy of stem cell treatment. However, the high cost of the therapy may affect market growth.

The global stem cell market is estimated to be $88.3 billion by 2014, growing at a CAGR of 14.8 % from 2009 to 2014. The U.S. currently holds a 60% share of the global stem cell market; and forms an especially lucrative market for areas such as bone marrow transplantation through stem cells. This research report will help stakeholders gain a better understanding of product pricing and regulatory framework governing the dynamics of the stem cell market. The key players in the market include Osiris Therapeutics, Stem Tronix Inc., Stemcell Technologies, Genzyme Corp., Cytori, and Geron.
Market Estimates and Forecasts The report categorizes the global stem cell market as follows: - Stem Cell Products (adult stem cell, human embryonic stem cell, and other stem cell types) - Stem Cell Services (stem cell banking, stem cell acquisition and testing, drug discovery and target identification, isolation/characterization services, and molecular biology ) - Stem Cell Technologies (stem cell acquisition, stem cell production, cryopreservation, and expansion and subculture) - Stem Cell Applications (regenerative medicine - neurological disorders, orthopedics, cancer, hematological disorders, myocardial infarction and cardiovascular diseases, injuries, diabetes, liver disorder, incontinence, and drug development)

Analyst Briefing Presentation on the Global Stem Cells Market to be held on 18th November, 2009
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Human stem cells transformed into key neurons lost in Alzheimer’s

2011-03-07T19:44:00.000-08:00

CHICAGO — Northwestern Medicine researchers for the first time have transformed a human embryonic stem cell into a critical type of neuron that dies early in Alzheimer’s disease and is a major cause of memory loss.

This new ability to reprogram stem cells and grow a limitless supply of the human neurons will enable a rapid wave of drug testing for Alzheimer’s disease, allow researchers to study why the neurons die and could potentially lead to transplanting the new neurons into people with Alzheimer’s.

The paper will be published March 4 in the journal Stem Cells.

These critical neurons, called basal forebrain cholinergic neurons, help the hippocampus retrieve memories in the brain. In early Alzheimer’s, the ability to retrieve memories is lost, not the memories themselves. There is a relatively small population of these neurons in the brain, and their loss has a swift and devastating effect on the ability to remember.

“Now that we have learned how to make these cells, we can study them in a tissue culture dish and figure out what we can do to prevent them from dying,” said senior study author Jack Kessler, M.D., chair of neurology and the Davee Professor of Stem Cell Biology at Northwestern University Feinberg School of Medicine and a physician at Northwestern Memorial Hospital.

The lead author of the paper is Christopher Bissonnette, a former doctoral student in neurology who labored for six years in Kessler’s lab to crack the genetic code of the stem cells to produce the neurons. His research was motivated by his grandfather’s death from Alzheimer’s.

“This technique to produce the neurons allows for an almost infinite number of these cells to be grown in labs, allowing other scientists the ability to study why this one population of cells selectively dies in Alzheimer’s disease,” Bissonnette said.

The ability to make the cells also means researchers can quickly test thousands of different drugs to see which ones may keep the cells alive when they are in a challenging environment. This rapid testing technique is called high-throughput screening.

Kessler and Bissonnette demonstrated the newly produced neurons work just like the originals. They transplanted the new neurons into the hippocampus of mice and showed the neurons functioned normally. The neurons produced axons, or connecting fibers, to the hippocampus and pumped out acetylcholine, a chemical needed by the hippocampus to retrieve memories from other parts of the brain.

Human skin cells transformed into stem cells and then neurons
In new, unpublished research, Northwestern Medicine scientists also have discovered a second novel way to make the neurons. They made human embryonic stem cells (called induced pluripotent stem cells) from human skin cells and then transformed these into the neurons.

Scientists made these stem cells and neurons from skin cells of three groups of people: Alzheimer’s patients, healthy patients with no family history of Alzheimer’s, and healthy patients with an increased likelihood of developing the disease due to a family history of Alzheimer’s because of genetic mutations or unknown reasons.

“This gives us a new way to study diseased human Alzheimer’s cells,” Kessler said. “These are real people with real disease. That’s why it’s exciting.”

Researcher motivated by his grandfather’s Alzheimer’s disease
Bissonnette’s persistence in the face of often frustrating research was fueled by the childhood memory of watching his grandfather die from Alzheimer’s.

“I watched the disease slowly and relentlessly destroy his memory and individuality, and I was powerless to help him,” Bissonnette recalled. “That drove me to become a scientist. I wanted to discover new treatments to reverse the damage caused by Alzheimer’s disease.”

“My goal was to make human stem cells become new healthy replacement cells so that they could one day be transplanted into a patient’s brain, helping their memory function again,” he said.
Bissonnette had to grow and test millions of cells to figure out how to turn on the exact sequence of genes to transform the stem cell into the cholinergic neuron.

“A stem cell has the potential to become virtually any cell in the body, from a heart cell to a layer of skin,” he explained. “Its development is caused by a cascade of things that slowly bump it into a final cell type.”

But it wasn’t enough just to develop the neurons. Bissonnette then had to learn how to stabilize them so they lived for at least 20 days in order to prove they were the correct cells.

“Since this was brand new research, people didn’t know what kind of tissue culture mature human neurons would like to live in,” he said. “Once we figured it out, they could live indefinitely.”

The research was supported by the National Institutes of Health.

NORTHWESTERN NEWS: www.northwestern.edu/newscenter/

International study shows reprogramming cells lead to genomic aberrations

2011-02-23T17:00:00.000-08:00

21. February 2011
The Medical News

It's a discordant note in the symphony of good news that usually accompanies stem cell research announcements. Stem cells hold enormous promise in regenerative medicine, thanks to their ability to regenerate diseased or damaged tissues. They have made it possible to markedly improve the effectiveness of many medical treatments - muscle regeneration in cases of dystrophy, skin grafts for treating burn victims, and the treatment of leukemia via bone marrow transplants.

The problem is obtaining them. Those that are the true source of life, in the first days of embryonic development, are of course the most highly sought after; still undifferentiated, they are "pluripotent," meaning they can evolve into liver, muscle, eye - any kind of cell. But the issue of how to obtain them clearly raises insurmountable ethical questions.

"In this regard, the recent discovery of the "reprogramming" phenomenon, by which somatic cells can be induced to convert to a pluripotent state simply by forcing the expression of a few genes, opens a phenomenal number of possibilities in regenerative medicine," says Didier Trono, Dean of the EPFL School of Life Sciences. "Imagine, for example, collecting a few cells from the hair follicle of a hemophiliac patient, reprogramming them to the pluripotentiality of their embryonic precursor, correcting the mutation responsible for the coagulation disorder that plagues the patient, and then re-administering them, genetically "cured," after having orchestrated a differentiation into fully functional progeny."

Increased risks for cancer?

But a study that has just been published in the journal Cell Death and Differentiation, to be followed by two articles in the journal Nature, is dampening those hopes. Conducted by the Department of Biochemistry at the University of Geneva and the European Institute of Oncology in Milan, with the participation of Trono's laboratory, it concludes that these reprogrammed cells exhibit a "genomic instability" that appears to be caused by the process used to return the cells to their embryonic state. Even more serious, the genetic mutations observed resemble mutations that are found in cancer cells. The scientists draw the conclusion that reprogrammed stem cells need to be extensively investigated before they can even be considered for use in regenerative medicine.

The experiments were done using mouse mammary and fibroblast cells. The researchers used three different processes for reprogramming the cells to a "stem," or embryonic, state. The first method was developed expressly for this study, and the others have already been well documented.

Yet all the processes led to the same, implacable conclusion: the genetic anomalies multiplied, in a manner that seems to indicate that they are inherent to the reprogramming process itself, which typically makes use of oncogenes. "Interestingly, oncogenes have the potential to induce genomic instability," the authors explain.

These results underline the necessity of conducting further studies. First, to see if the genetic anomalies are serious enough to compromise the function and stability of cells regenerated using the reprogrammed cells; and second, to "refine the methods used for generating induced pluripotent cells, in order to avoid this problem. These results will thus motivate scientists to come up with a solution," concludes Trono.

Source: Ecole Polytechnique Federale de Lausanne

Stem Cells versus Progenitors

2011-02-16T18:38:00.001-08:00

Posted by Teisha on February 13th, 2011
the Node

With so much research focusing on stem cells, I’ve been wondering lately whether researchers are overlooking other important, multipotent cell groups, specifically what are called “progenitor” cells. But then another part of me wonders whether these two groups are so very different from each other. Technically, the main difference between stem cells and progenitors is their lifespan, with progenitors’ being much shorter, but the line here seems blurry; most adult stem cells cannot be cultured for extensive amounts of time before they differentiate or senesce.

I was reminded of the issue of stem cells versus progenitors by a paper that came out earlier this month in The Journal of Clinical Investigation that showed, surprisingly, that patients with androgenic alopecia (AGA), or male pattern baldness, had a normal number of hair stem cells in their scalps, but a depleted number of different hair progenitor cells. The progenitors now look like a likely culprit for AGA. It’s been well-studied how stem cells in hair follicles give rise to new hairs over time, and it’s known that progenitors derived from these stem cells play key roles in this process, but it had not been studied with relation to AGA previously. It’s possible that the stem cells in bald AGA scalps are somehow dysfunctional or inactivated, and this could cause the loss of progenitor cells, but it still needs to be looked into (If you’d like to read more detailed coverage of this paper, I wrote a technical blog post about it on my blog All Things Stem Cell and a layman article on it for my column Biology Bytes.)

I wonder what would have happened to this recent study if when the researchers had found out that the number of hair stem cells was the same in haired and bald scalps, they then moved on to investigating other, maybe non-cellular suspects, without looking at the progenitors. Perhaps they would have then discovered a molecular abnormality in the stem cells, and then suspected the downstream progenitor groups. I just can’t help but wonder how many other diseases and biological phenomena have been investigated with a primary focus on the stem cells involved, when in some cases the progenitors may be a better initial indicator for what’s changed in the system. Or maybe using the terms “stem cells” and “progenitors” is really splitting hairs; stem cells vary significantly in potency and proliferation capacity from group to group, so maybe we should just expand the already expansive term “stem cells” to encompass a broader range of cells. While I like to think that a cell type’s name doesn’t affect whether a researcher studies it, I’d imagine it’s easier to get funding for “stem cell” research than “progenitor cell” research (or, with some funding agencies it may be the other way around), and this may definitely affect a researcher’s focus with funding as tight as it is.

Mom’s stem cells might cure genetic defects of the fetus

2011-01-24T16:05:00.000-08:00

By Janet Fang

Jan 24, 2011
smartplanet

Why do fetuses reject stem cell implants? Researchers have puzzled over this for a decade. A new mouse study suggests that the mother’s immune system is to blame – and as it turns out, her stem cells are also the solution.

If translatable into humans, this means that congenital blood disorders, like sickle cell anemia and beta thalassemia, could be treated before birth.

As early as the first trimester of pregnancy, doctors can diagnose certain genetic diseases – which they’ve hoped to treat with fetal stem cell transplants because immature immune systems should better tolerate foreign substances.

Implanted cells should replenish the fetus’s supply of healthy blood-forming cells, but these transplantations haven’t been very successful.

According to new research, it’s the mother’s immune response that prevents the fetus from accepting transplanted blood stem cells. And the solution? Transplanting cells harvested from the mother herself.

Researchers from the University of California at San Francisco figured that out by taking a close look at the blood cells of mouse embryos (pictured).

1. First, they found that up to 10% of the fetus’s blood cells came from the mother – an unexpectedly large proportion. It made them think that it’s the maternal, rather than fetal, immune response that “poses the real barrier to effective stem cell transplantation,” says study author Tippi MacKenzie.

2. Then they conducted the transplant with blood from unmatched mice donors. They watched as the mother’s immune cells traveled into the fetus and rejected the transplant. “The surprising finding in our study is that the mother’s immune system is to blame,” coauthor Qizhi Tang explains.

3. Next, they removed immune cells from the mother before the transplant, and got a nearly 100% success rate.

4. So they figured out the solution and transplanted fetal mice with blood stem cells harvested from the mother – which “makes sense because the mother and her developing fetus are prewired to tolerate each other,” adds coauthor Amar Nijagal.

“This research is really exciting because it offers us a straightforward, elegant solution that makes fetal stem cell transplantation a reachable goal,” MacKenzie says. “We now, for the first time, have a viable strategy for treating congenital stem cell disorders before birth.”

The team next hopes to confirm the study in humans. This finding was published in the Journal of Clinical Investigation online last week.

LETTER: Stem cell research leaps forward

2011-01-24T16:01:00.000-08:00

SAN ANGELO, Texas — Bishop Michael Pfeifer, Catholic Diocese of San Angelo

In recent years there has been much discussion about the ethical dimensions of using human embryos in stem cell research. Recent scientific research points out clearly that it is not necessary to destroy human embryos to acquire stem cells for medical purposes, as they can be acquired in other ethical ways — by "reprogramming" human cells.

Induced pluripotent stem, or iPS, cells have become the hope of the scientific world in the last few years. Dr. Shinya Yamanaka was the first to generate iPS cells, publishing a seminal paper in August 2006 that showed that the addition of four genes could convert a normal mouse skin cell to an embryonic-like stem cell.

Barely a year later, Yamanaka, as well as James Thomson, showed that the same "reprogramming" could be accomplished with human cells. Latest research shows this happens now with any one gene and using no DNA.

This rapidly advancing science clearly points out that there is no need to use embryonic stem cells in medical research. IPS cells behave like embryonic stem cells but are created without the use of embryos, eggs or cloning technology while respecting human life.

Additionally, iPS cells have several advantages over embryonic stem cells — they are easier and cheaper to make than embryonic stem cells, and they can be made directly from almost any tissue from any person.

Because of its ease and utility, iPS cell research has outpaced the antiquated embryonic stem cell research while adult stem cells continue to be used to treat actual patients.

© 2011 San Angelo Standard Times. All rights reserved.

Stem cells in 2020

2011-01-07T12:43:00.000-08:00

Chxa.com

Before going ahead and explaining the possibilities that are on the verge of development based on the regenerative capabilities of a stem cell, let us first understand what a stem cell is actually. Stem cells are the basic group of cells that have the extremely potent capability of regenerating themselves. The process through which they regenerate themselves is known as mitotic cell division and after the division, the previously unspecialized cells turn into specialized cells for specific organs through cellular differentiation. These cells are not found in unicellular organisms, but are found in varying quantities within all multi cellular organisms. Embryonic stem cells and adult stem cells are the two types of stem cells that are present inside all mammals naturally. The function of the embryonic stem cells is to differentiate and form all of the embryonic organs and tissues. As adult stem cells, they are more given towards repairing organ cells, but they constantly contribute to regeneration by helping the natural renewal of skin and blood.

As the stem cells in a human being possess regenerative properties along with the ability to form specialized cells, they have been a great prospect for achieving ground breaking technological progress in the field of medical science since 1960, when Ernest A. McCulloch and James E. Till started it all in the University of Toronto. The study on cell culture has allowed us at the moment, to control both the growth and differentiating property of certain stem cells, which subsequently can be used to create specialized muscle and nerve cells. Now that medical science is able to incorporate autologous transplantations and stem cell culture successfully up to a small extent, the prospects in the next decade look bright for the field.

Somatic Cell Nuclear Transfer is commonly called “cloning” and it is with cloning that some of the greatest medical breakthroughs of the future might rest. This is a laboratory process which involves removing the nucleus of both the somatic cell and the egg cell, but the difference lies in the fact that in case of the non-reproductive cell, only the nucleus is retained, while in case of the egg cell, only the nucleus is discarded. The nucleus of the somatic cell is now entered inside the egg cell as a replacement for the nucleus that was removed earlier. On accepting the nucleus, the fertilized cell starts to divide after the required stimulation. The blastocyst that forms through the series of mitotic divisions can now be called a “clone” or a genetic duplicate of the host. The use of this procedure is multifaceted and holds great promise for the future. If the SCNT procedure was performed successfully to create the stem cells responsible for a particular type of disease, then it would be so much easier to study the disease and know almost everything that there is to know about it. This extensive knowledge gained could then be used to device a cure for that particular disease or genetic disorder. If it is possible to create customized cells, then a very important step could be taken in matters of medical transplantation. The most common problem with cell-based treatments is that there remains a chance that the immune system of the patient may reject the procedure, but if SCNT is implemented successfully in the near future, even entire organ transplants would not be rejected as it would be made from the stem cells of the patient itself. Human cloning does come to mind while observing the pattern of the procedure but it is a far more complex process than cloning a sheep (Dolly). Although it is considered by some to be too complicated, others believe that stem cells hold the key to human cloning in the coming years.

“Induced pluripotent stem cells” or iPSCs is another technology that is based on the ongoing research about possible uses of the stem cell’s properties now and in the future. This is a technique that involves making a somatic cell of the body; behave like a pluripotent stem cell by genetically manipulating it. The iPSCs have most things in common with the natural stem cells in terms of teratoma structure, chimera structure, embryoid structure along with the differentiability and the ability to regenerate. One problem that might arise while using the iPSCs is the chance of these converted pluripotent cells turning out to be cancerous in nature because of the genetic engineering that they go through. This is one of the biggest barriers that stand in front of therapeutic initiation of iPSCs in human beings, but in 2008, a scientific journal suggested ways of countering and completely removing oncogenes. The appropriate implementation of the technique as well as the entire procedure is still a few years away, but hopes are that by 2020, medical experts will be able to do all of this successfully.

We have touched a portion of the popular forms of research on stem cells that is going on today to yield results for tomorrow, let us now consider some final adaptations of those techniques in medical science that we can expect by the year 2020.

1. Alopecia or Baldness – Hair loss is a common problem that men and women suffer from all over the world, but the reasons may differ from individual to individual though. As premature baldness is a seriously undesirable effect, entire industries of hair care products and hair treatment centers have come into being, but the technology to initiate dependable hair growth is yet not available to us. It is believed that by the year 2020, growth of new hair from the scalp and restoration of old malfunctioning hair follicles can be made possible through developments on stem cell research.

2. Regeneration of external body parts (limbs) – It may sound farfetched at this moment, but due to the discovery of the P21 gene, it might just be possible in the year 2020. The function of this cell is to prevent cancerous growth when the DNA of the cell is damaged, but by controlling P21, it might be possible in the future to make the cells grow in a regenerative fashion, instead of growing in a cancerous manner. It may even be possible to repair brain cells with this procedure.

3. Regeneration of hearing abilities and teeth – Deafness is a result of malfunctioning or damaged cochlear and vestibular hair cells that are found within our inner ears. It might be possible to repair or re-grow these hair cells through inducing stem cells with proper stimulation. Although it is a success with mice already, human beings might have to wait till the year 2020 to actually benefit from this method. Expected also by 2020, is tooth regeneration. Fillings will no longer be necessary and artificial teeth will become obsolete as well, because stem cells and scaffold matter, with the assistance of signaling molecules, should allow doctors to grow perfect teeth that can replace old and rotting ones from the gum.

4. Organ transplantation – The most anticipated breakthrough that medical science hopes to achieve by 2020, is the ability to grow an entire organ fit for transplantation to the patient. Heart is the priority, but liver, kidney, lungs and other organs will also be safely transplantable once the stem cell technology reaches such a level that medical science is not limited to only growing specific tissues, tendons and cartilages. If growing an organ using the stem cells of the patient itself becomes possible, then the results could be globally influential. No one will need to donate their organs to save someone and the costs of transplantation would also come down to a more affordable level. Furthermore, the possibility of immune system rejection will also be nullified. Naturally, this would bring down the death rate among human beings due to organ failure to a remarkable minimum.

Embryonic Stem Cell Treatment Of Progressive Blindness; FDA Clears Clinical Trials

2011-01-07T12:26:00.000-08:00

Medical News Today

Significant advancements in somewhat controversial stem cell research continue in 2011. Having no current treatments available, the leading cause of vision loss may be able to be treated using human embryonic stem cells. Just today, it was announced that the US Food and Drug Administration has approved clinical trials of an application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial cells derived from human embryonic stem cells. Dry AMD afflicts between 10-15 million Americans.

Advanced Cell Technology (ACT) announced that they are now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90% of all cases. The progress of Dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient's macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

Dry macular degeneration is diagnosed when yellowish spots known as drusen, begin to accumulate in and around the macula, an oval-shaped highly pigmented yellow spot near the center of the retina of the human eye. The macula absorbs excess blue and ultraviolet light that enter the eye, and acts as a natural sun block for this area of the retina. It is believed these spots are deposits or debris from deteriorating tissue. Dry AMD through a period of years slowly can progress into a gradual degradation of retinal cells that also can cause severe vision loss. There are currently no treatments available for this prevalent disease of an aging global population.

Gary Rabin, Interim Chairman and CEO of ACT, a biotechnology company applying cellular technology in the field of regenerative medicine, in a statement says:

"ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine. It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible."

The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.

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Robert Lanza, MD, ACT's Chief Scientific Officer provides some more background:

"Dry AMD is the leading cause of blindness in individuals over the age of 55. As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt's Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt's Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt's Disease and Dry AMD patients."

Stargardt's disease (also known as fundus flavimaculatus and Stargardt macular dystrophy) is the most common form of inherited juvenile macular degeneration. Inherited as an autosomal recessive trait, it is a severe form of MD that begins in late childhood, leading to legal blindness. Stargardt disease is symptomatically similar to age-related macular degeneration, and it affects approximately one in 10,000 children.

While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the Company hopes to demonstrate that the retinal pigment epithelial cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

Edmund Mickunas, ACT's Vice President of Regulatory Affairs concludes:

"It is estimated that over ten million Europeans suffer from Age-Related Macular Degeneration, representing a vast unmet need and a significant market opportunity. We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe."

Specific inclusion and exclusion requirements and Investigator contact information will be posted at clinicaltrials.gov.

Written by Sy Kraft, B.A.

Copyright: Medical News Today

Scientists Use Stem Cells To Create Mice With Two Genetic Fathers

2010-12-17T23:40:00.000-08:00

By Rebecca Boyle
Posted 12.08.2010
POPSCI

Using stem cell technology, scientists have produced male and female mice from two fathers, a breakthrough that could conceivably allow same-sex couples to have their own genetic children.
The multi-generational technique combines genes from the chromosomes of two male mice and uses surrogate mothers, according to researchers at the M.D. Anderson Cancer Center at the University of Texas.

To produce the male and female offspring, the team first manipulated tissue cells from a male mouse fetus to produce an induced pluripotent stem cell line. Without explaining why, the team says about one percent of these iPS cells spontaneously lost their Y chromosomes, resulting in XO cells. In humans, this monosomy is known as Turner syndrome; girls with the disorder usually have various physical abnormalities and cognitive defects. Normally, people have one pair of sex chromosomes in each cell — women have two X chromosomes and men have X and Y.
The scientists injected the XO stem cells into blastocysts from donor female mice, and these early embryos were implanted into surrogate mothers. When the mothers gave birth, their female offspring were XO/XX chimeras — they had one X chromosome from the original male mouse cells. Finally, the researchers harvested egg cells from these chimeras and mated them with normal male mice. The result was male and female offspring that had chromosomes from two fathers — from the regular male and derived from the stem cells.

The team said their results are a new form of mammalian reproduction, and that it could be used to combine genetic traits from two males without having to involve any women. It could even be possible to produce sperm and eggs from one male, the researchers say.

One day, they might even be able to produce human eggs from male stem cells in a living male. This would eliminate the need to produce XO chimeras, the researchers say.

But don’t worry, fellow XXers: We're not obsolete, because women will still be necessary to carry the two-father pregnancy to term. At least until they develop a robotic uterus.

Fibrin microthreads support mesenchymal stem cell growth

2010-12-10T22:05:00.000-08:00

The Medical News
10. December 2010

Research team at Worcester Polytechnic Institute shows that stem cells thrive on microthread sutures, creating a novel platform for cellular therapies that may regenerate cardiac tissue

A research team at Worcester Polytechnic Institute (WPI) has demonstrated the feasibility of a novel technology that a surgeon could use to deliver stem cells to targeted areas of the body to repair diseased or damaged tissue, including cardiac muscle damaged by a heart attack. The technique involves bundling biopolymer microthreads into biological sutures and seeding the sutures with stem cells. The team has shown that the adult bone-marrow-derived stem cells will multiply while attached to the threads and retain their ability to differentiate and grow into other cell types.

The results are reported in the paper "Fibrin microthreads support mesenchymal stem cell growth while maintaining differentiation potential," which was published online, ahead of print, on Nov. 29, 2010, by the Journal of Biomedical Materials Research

(http://onlinelibrary.wiley.com/doi/10.1002/jbm.a.32978/abstract).

"We're pleased with the progress of this work," said Glenn Gaudette, assistant professor of biomedical engineering at WPI and lead author on the paper. "This technology is developing into a potentially powerful system for delivering therapeutic cells right to where they are needed, whether that's a damaged heart or other tissues."

(To read the rest of this article, please click on the link in this blog post's title above.)

States now fund majority of human embryonic stem cell research

2010-12-10T21:59:00.000-08:00

Public release date: 9-Dec-2010

Contact: David Terraso
david.terraso@comm.gatech.edu
404-385-2966
Georgia Institute of Technology

States, not the federal government, now fund the majority of human embryonic stem cell research conducted in the United States, according to a recent study in the journal Nature Biotechnology. In addition, states varied substantially in the extent to which they prioritized human embryonic stem cell research, and much of the research performed in the states could likely have been funded by the National Institutes of Health under federal guidelines established by President Bush in 2001.

"While the federal government still contributes more to stem cell research overall, each year since 2007 these six states have funded more human embryonic stem cell research than the federal government," said Aaron Levine, assistant professor at Georgia Tech.

Levine created an online searchable database (http://www.stemcellstates.net/) that allows users to find detailed information about each grant given out by the six states that adopted programs specifically to fund stem cell research. The database currently covers grants given out by California, Connecticut, Illinois, Maryland, New Jersey and New York from December 2005 to December 2009, and will be updated yearly with new information.

"From what I could tell, only a relatively small portion of the stem cell research supported by these states was clearly ineligible for federal funding," said Levine, who is on the faculty of the School of Public Policy in the Ivan Allen College of Liberal Arts.

Levine reasons this could be a result of the fact that there are many incentives for scientists to work with existing human embryonic stem cell lines rather than creating new ones.

He said he was surprised at how great the difference was among states in the share of grants that supported human embryonic stem cell research. While Connecticut and California devoted 97 percent and 75 percent of their grants to this research, New Jersey and New York steered only 21 percent to this contentious field.

One reason for these differences may be the development of induced pluripotent stem cells, which are derived from adult body cells rather than from embryos. More recent programs, such as New York's, may be disproportionally focusing on this new technology.

"There's no question that these state programs drew a lot of scientists into the field," said Levine. "An interesting question going forward is how committed these scientists are to stem cell research or if they are relating their work to stem cells now simply to be eligible for state funding – that's unknown right now."

The future of stem cell research

2010-12-08T18:07:00.000-08:00

December 8, 2010 By Eryn Brown
Physorg.com

Perhaps no single scientist has had a greater impact
on stem cell research than Dr. Shinya Yamanaka. While most of his colleagues
were looking for ways to grow human embryonic stem cells into replacement
tissues for treating patients, the Japanese researcher took the opposite
approach and figured out how to rewind mature body cells to a flexible state
where they could again become many types of cells in the body. His 2006
discovery of so-called iPS cells (induced pluripotent stem cells) paves the way
for pursuing regenerative medicine therapies without the need to destroy
embryos.

Yamanaka's primary lab is at Kyoto University in Japan, but he spends part of
the year at the University of California San Francisco's Gladstone Institute of
Cardiovascular Disease, where he was a postdoctoral fellow in the 1990s. On Nov.
10 he received the $610,000 Kyoto Prize, which awards "significant contributions
to the betterment of humankind," for his stem cell work. He has also won the
Albert Lasker Basic Medical Research Award, the Shaw Prize and the Robert Koch
Prize. He recently spoke with the Los Angeles Times.

Q: What prompted you to start working on iPS cells?

A: In 2000, I became interested in how embryonic stem cells maintain
their ability to develop into different kinds of cells. At the time, many
laboratories were trying to turn embryonic stem cells into various functional
cells. I thought the field was highly competitive, so I decided to go the
opposite direction - (turning body cells) back to the embryonic state.

Q: What advantages do iPS cells have over embryonic stem cells?

A: IPS cells can circumvent two obstacles faced by embryonic stem cells. One
is the ethical controversy - we have to destroy embryos to isolate embryonic
stem cells. The other is the risk of immune
rejection when cells derived from embryonic stem cells are transplanted into
a patient's body.

Q: Do they have any disadvantages?

A: The safety of the cells. They are made by using retroviruses to introduce
genes into mature cells, but the process can cause iPS cells to grow tumors if
the retrovirus is inserted in the wrong part of the genome.

Q: What is the long-term potential of these cells?

A: IPS cells can become an effective research tool for modeling drugs,
screening drug compounds and testing for side effect or toxicity. In the future,
when the safety and other issues are solved, iPS cell-derived functional cells
may become sources for cell transplantation therapies.

Q: What surprised you most about your research as it unfolded?

A: When our group succeeded in generating iPS cells, I never imagined so many
researchers would begin working on this new technology - or that the research
would advance at such a rapid pace.

Q: What are the primary scientific hurdles that remain with iPS cells?

A: Scientists need to find out the methods to generate safer iPS cells, how
to turn those cells into functional cells, and how to transplant resultant cells
into a body. We also need to figure out how to use the cells to study diseases
in the lab.

Q: In the United States, the first clinical trial involving a therapy derived
from human embryonic stem cells has just gotten under way. How do you feel about
the pace of translating research into actual treatments?

A: The clinical trial using embryonic stem cells took a long time partly
because use of the cells has caused an ethical controversy around the world. It
is also true that it generally takes many years to turn basic research into
clinical applications.

Q: Some question why human embryonic stem cell research should continue when
your discovery allows scientists to generate similar cells without destroying
human embryos. What do you think?

A: Embryonic stem cells are still important for the development of iPS cell
research. Findings from research on embryonic stem cells, such as methods to
create various types of cells, have been applied to iPS cell research. That's
why iPS cell research has evolved so rapidly. In addition, embryonic stem
cells are used as control (comparison) materials when researchers conduct
experiments on iPS cells and analyze their quality.

Q: Many people speculate that you will win a Nobel Prize one day. Does that
make it hard to get your work done?

A: I know some people have high expectations, but my concern is not thinking
about winning a Nobel Prize. I worry about what I should do to bring iPS cell
technology from the laboratory to the bedside as soon as possible.

Congress Faces Deadline on Embryonic Stem Cell Research Funding Policy

2010-12-07T21:10:00.000-08:00

Friday, December 03, 2010

California HealthLine

Unless Congress passes legislation by the end of the year to allow federal funding for embryonic stem cell research, former President George W. Bush's policy limiting such funding would take effect, The Hill reports.

Background

Shortly after taking office, President Obama reversed the Bush-era policy restricting federal funds for embryonic stem cell research (Pecquet, The Hill, 12/2). In August, U.S. District Court Judge Royce Lamberth issued a preliminary injunction on Obama's order, ruling that the policy violates a 1996 law known as the Dickey-Wicker Amendment.
In September, the U.S. Court of Appeals in Washington, D.C., temporarily lifted the injunction to give judges time to consider the merits of Lamberth's decision and the Obama administration's counterarguments (California Healthline, 9/14).

Pending Legislation

If Congress passes legislation to clarify the 1996 law, it would make the appeals court decision moot, according to The Hill. Such legislation has bipartisan support and has passed Congress twice but was vetoed each time by Bush.
Opponents of the legislation say embryonic stem cell research is immoral because it requires the destruction of embryos.
Rep. Diana DeGette (D-Colo.), who introduced the bill in the House, said House Majority Leader Steny Hoyer (D-Md.) is not putting the legislation before the House unless the Senate pledges to take up the bill.
DeGette said the legislation could have a chance to pass next year if it does not pass this session. However, Rep. Mike Castle (R-Del.), a co-sponsor of the legislation, said it is "evident that absolutely nothing will pass in the next Congress."
Castle suggested the appeals court stay that allowed funding to temporarily continue actually might have decreased the sense of urgency for passing legislation (The Hill, 12/2).

Read more: http://www.californiahealthline.org/articles/2010/12/3/congress-faces-deadline-on-embryonic-stem-cell-research-funding-policy.aspx#ixzz17UgWHCRi

Bush stem cell policy may return

2010-12-02T17:39:00.000-08:00

By Julian Pecquet - 12/02/10
The Hill

Congress is running out of time to pass legislation allowing federalfunding for embryonic stem cell research, potentially setting up theresumption of a Bush-era policy that President Obama reversed withfanfare shortly after taking office.

Without legislative action by year’s end, federal funding for the controversial research could once again be highly restricted, as it was under former President George W. Bush.
An appeals court could rule either way within the next few months, but legislation pending in the House and Senate could effectively make the decision moot by clarifying a 1996 law that bans the use of taxpayer money for research where human embryos are destroyed.

“Obviously, with every day that goes by, it becomes less likely” that the bill will pass, said Rep. Mike Castle (R-Del.), a co-sponsor of the legislation. “I’d like to see it happen, but I’m not exactly holding my breath.”
Obama’s order allows federal funding for biomedical research that uses embryonic stem cells to search for potential prevention or treatment of diseases such as Parkinson’s disease, Alzheimer’s and diabetes. Opponents say the practice is immoral and should not be funded by taxpayers because it requires the stem cells to be destroyed.
The mood among proponents of the legislation is a complete reversal from March 2009, when Obama signed an executive order reversing an eight-year moratorium. “We will vigorously support scientists who pursue this research, and we will aim for America to lead the world in the discoveries it one day may yield,” the president said at the time.
A federal judge struck down Obama’s order in August, saying it violated the 1996 Dickey-Wicker Amendment, a rider that makes it illegal to use federal monies to support research in which human embryos are created, destroyed or discarded. But an appeals court allowed the current policy to remain in place temporarily until it rules on the issue.
Rep. Diana DeGette (D-Colo.), who introduced the House bill, told The Hill she’s confident the bill could pass in both chambers. But she said House Majority Leader Steny Hoyer (D-Md.) has been reluctant to take time from the House’s busy schedule to pass the bill unless the Senate commits to taking it up.
“I’ve talked to my leadership about it and they say it’s still not off the table,” DeGette said. “The concern is ... an issue of time. Why would we have a vote on something like this if it’s not going to come up in the other body?”
The legislation has bipartisan support, and twice passed Congress before being vetoed by Bush. It first passed in 2005 by a 238-194 margin in the House, with 50 Republicans voting in favor. It passed again in 2007 by a vote of 247-176, with 37 Republicans voting yes. Eighteen Republican senators voted for it the first time, and 16 the second. Most are still in the Senate.
DeGette said she was also encouraged by the fact that Mark Kirk (R-Ill.), a member of the Congressional Stem Cell Whip Team when he was in the House, has been sworn in as a senator and can make a strong case directly to Senate Majority Leader Harry Reid (D-Nev.).
But asked about the likelihood of the Senate taking up the issue, a Reid spokesman pointed to a recent letter signed by every Senate Republican vowing to hold up all controversial legislation until the expiring Bush tax cuts are dealt with.
Even if the bill doesn’t pass this session, DeGette says the legislation could have a chance next year. She pointed to a recent Harris Interactive poll that found 72 percent of Americans are in favor of using embryonic stem cells left over from in vitro fertilization procedures for medical research.
“I don’t think it’s the last chance,” DeGette said. “We’re now beginning to see some real results from the research that’s happened. There’s been two human-subject studies that have been approved by the Food and Drug Administration just in the past two months, so you’re going to see more scientific advances. And so, if the new Republican majority in the House starts trying to put limitations on research or ban research, or if the court decision comes out the wrong way, then you’re going to see a renewed emphasis on codifying this.”
But Castle wasn’t as sanguine about the bill’s reception in a Congress controlled by his Republican colleagues.
“It’s evident that absolutely nothing will pass in the next Congress,” Castle told The Hill, “so if we’re going to do it, we have to do it during this lame duck.”
Paradoxically, the appeals court’s stay may have dampened the urgency for getting legislation passed, Castle suggested.
“I think that’s an important factor in all of this,” he said, “because then the whole thing could have stopped if we didn’t get something done [in Congress]. Now, with the injunction, things can go on limping along.”

Scientists home in on chemicals needed to reprogram cells

2010-12-02T17:36:00.000-08:00

December 2, 2010
Physorg.com

Scripps Research Institute scientists have made a
significant leap forward in the drive to find a way to safely reprogram mature
human cells and turn them into stem cells, which can then change into other cell
types, such as nerve, heart, and liver cells. The ability to transform fully
mature adult cells such as skin cells into stem cells has potentially profound
implications for treating many diseases.

In research published in the December 3, 2010 issue of Cell Stem Cell,
Scripps Research Associate Professor Sheng Ding, PhD, reports a novel cocktail
of drug-like small molecules that, with
the assistance of a gene called Oct4, enables reprogramming of human skin
cells into stem cells.

"Our ultimate goal is to generate induced pluripotent
stem cells with defined small molecules," Ding said. "This would offer a
fundamentally new method and significant advantages over previous methods, such
as genetic manipulation or more difficult-to-manufacture
biologics."

Using small-molecule compounds to reprogram adult human cells back to their
pluripotent state — able to change into all other cell types — avoids the
ethical controversy around embryonic stem cell research, and paves the way for
the large-scale production of stem cells that could
be used inexpensively and consistently in drug development. Cures for
Alzheimer's, Parkinson's, and many other diseases might be possible if new cells
could be created from a patient's own cells to replace those that have succumbed
to disease or injury.

Substituting Chemicals for Genes

Scientists discovered in 2007 that fully differentiated mature cells, such as
skin cells, could be "reprogrammed" to become pluripotent by using four
transcription genes. One problem with this technique is that these genes, once
inserted into a cell, permanently alter the host cell's DNA.

"There are many concerns when the host cell's genome is manipulated," Ding
says. "One major worry is that since the four genes are [cancer-causing]
oncogenes, they could induce tumors or interrupt functions of other normal
genes."

Because of this danger, scientists have been searching for methods that could
induce reprogramming without the use of these cancer-causing genes. The method
the Ding lab has been pioneering — using small, synthetic molecules — represents
a fundamentally different approach from the previous methods.

"We are working toward creating drugs that are totally chemically defined,
where we know every single component and precisely what it does, without causing
genetic damage," Ding says.

Breaking New Ground

Scientists have known for at least 50 years that a cell's identity is
reversible if given the right signal — cells go forward to become mature,
functional cells or they can go backward to become primitive cells. In order for
cellular reprogramming to be safe and practical enough to use in cell therapy,
researchers have sought an efficient, reliable way to trigger the reprogramming
process.

In 2008, the Ding lab reported finding small molecules that could replace two
of the required four genes. Now, two years later, through extraordinary effort
and unique screening strategy, the lab made a major leap forward by finding a
way to replace three out of the four genes.

"We are only one step away from the ultimate goal, which would represent a
revolutionary technology," Ding says.

The new study also revealed that the novel compound facilitates a novel
mechanism in reprogramming: the metabolic switch from mitochondrial respiration
to glycolysis, an important mechanism for tissue regeneration. The small
molecules Ding and his colleagues found promote reprogramming by facilitating
such metabolic switching — an entirely new understanding of reprogramming.

A future goal is to replace Oct4, a master regulator of pluripotency, in the
chemical cocktail. " That would be the last step toward achieving the Holy
Grail," Ding says. "Our latest discovery brings us one step closer to this
dream."

More information: The first author of the paper, "Reprogramming of
Human Primary Somatic Cells by OCT4 and Chemical Compounds," is Saiyong Zhu of
The Scripps Research Institute.

Provided by The Scripps Research Institute

Real Engagement: New PLoS Biology Series Highlights Efforts To Bring People And Scientists Together To Shape New Technologies

2010-12-01T07:08:00.000-08:00

Article Date: 01 Dec 2010
Medical News Today

Over the past few decades, numerous initiatives have sought public input on the
development of potentially controversial research, from stem cell and human
embryonic research to genetic engineering and nanotechnology. The reasons for
soliciting public participation vary - though most initiatives assume that such
participation is in the public interest - as do perspectives on just who
constitutes the "appropriate" public in such endeavours.

PLoS
Biology will explore the nature, aims, and consequences of such initiatives
in a new series, Public Engagement in Science, starting on November 30, under
the guidance of Nikolas Rose, professor of sociology and director of the BIOS
Centre for the Study of Bioscience, Biomedicine, Biotechnology and Society at
the London School of Economics, and Claire Marris, sociologist of science and
senior research fellow in BIOS at the London School of Economics.

This
series aims to investigate, through specific case studies, whether, and under
what conditions, it is possible to engage the public in scientific issues in
meaningful ways in decision making about the nature and consequences of
innovation in the biosciences. We will feature engagement initiatives that go
beyond merely collecting views of the public to those seeking to influence the
trajectory of scientific research, and the culture of scientific institutions.
We are soliciting articles written by or with scientists who have been involved
in such initiatives, describing examples where the diverse participants involved
agree that positive outcomes were achieved and so might provide models for
further development.

In the first article "'Interactive Technology
Assessment' and Beyond: the Field Trial of Genetically Modified Grapevines at
INRA-Colmar," published November 30, Jean Masson and colleagues describe their
experience using an approach called the interactive technology assessment
strategy to solicit input from a broad range of stakeholders for a field trial
of genetically modified grapevines in French winegrowing country, where
resistance to innovation runs deep.

To learn more about the series, see
the Editorial, "Open Engagement: Exploring Public Participation in the
Biosciences," by Rose and Marris.

Masson and colleagues article:

Funding: This research was funded by the INRA. The funders had no role
in study design, data collection and analysis, decision to publish, or
preparation of the manuscript.

Competing interests statement: The
authors declare that no competing interests exist.

Citation: The Local
Monitoring Committee, Lemaire O, Moneyron A, Masson JE (2010) "Interactive
Technology Assessment" and Beyond: the Field Trial of Genetically Modified
Grapevines at INRA-Colmar. PLoS Biol 8(11): e1000551.
doi:10.1371/journal.pbio.1000551

Rose and Marris Editorial:

Competing interests statement: The authors declare that no competing
interests exist.

Citation: Marris C, Rose N (2010) Open Engagement:
Exploring Public Participation in the Biosciences. PLoS Biol 8(11): e1000549.
doi:10.1371/journal. pbio.1000549

Source:
PLoS Biology

FDA clears second clinical trial involving human embryonic stem cells

2010-11-29T12:18:00.000-08:00

By Karen Kaplan
Los Angeles Times

November 22, 2010

Another therapy derived from human embryonic stem cells is headed
for clinical trials.

Advanced Cell Technology Inc. said Monday that the Food and Drug Administration
has cleared the way for its Phase I/II trial of retinal cells for patients with
Stargardt’s
macular dystrophy, a childhood version of macular degeneration. Up
to 12 patients will be enrolled at several sites across the country, including
the Casey Eye Institute in Portland, Ore., the University of Massachusetts
Memorial Medical Center in Worcester, and UMDNJ – New Jersey Medical School in
Newark.

Here’s a description of Stargardt’s
macular dystrophy from a previous Booster Shots post: "The
disease is a childhood version of macular degeneration and affects about one in
10,000 kids. Patients typically begin to lose their central vision between the
ages of 6 and 20. As SMD progresses, things may look blurry and distorted, and
patients may have trouble adjusting to low light. About half of victims are
legally blind by age 50. There is no cure."

Advanced Cell Technology hopes to treat these patients by giving them new
retinal pigment epithelium cells to replace the ones that are lost to the
disease. The therapy has restored vision in rats and mice, according to
published studies. The Phase I/II trial is designed to test the safety and
tolerability of the RPE cells in humans.

The RPE cells were grown from an unusual line
human embryonic stem cells that was made by extracting a single blastomere cell
from an eight-cell embryo. The technique is commonly used in pre-implantation
genetic diagnosis and does not require the destruction of an embryo.

Last month,
a patient in Atlanta became the first patient to be treated in an FDA-approved
clinical trial involving a therapy derived from human embryonic stem cells.
That clinical trial is testing cells made by Geron Corp. to treat people with
spinal cord injuries.

RELATED: Company
seeks FDA permission to conduct clinical trial using human embryonic stem cells

Reverting cells to their embryonic state, without the embryos

2010-11-28T15:05:00.000-08:00

Dr. Shinya Yamanuka of Japan discovered so-called iPS cells, which pave the way for pursuing regenerative medicine therapies without destroying embryos.

November 27, 2010
By Eryn Brown
Los Angeles Times

Perhaps no scientist has had a greater impact on stem cell research than Dr. Shinya Yamanaka. While most of his colleagues were looking for ways to grow human embryonic stem cells into replacement tissues for treating patients, the Japanese researcher took the opposite approach and figured out how to rewind mature body cells to a flexible state in which they could again become many types of cells. His 2006 discovery of induced pluripotent stem cells, or iPS cells, paves the way for pursuing regenerative medicine therapies without the need to destroy embryos.

Yamanaka's primary lab is at Kyoto University in Japan, but he spends part of the year at UC San Francisco's Gladstone Institute of Cardiovascular Disease, where he was a postdoctoral fellow in the 1990s. On Nov. 10 he received the $610,000 Kyoto Prize, which recognizes "significant contributions to the betterment of humankind," for his stem cell work. He has also won the Albert Lasker Basic Medical Research Award, the Shaw Prize and the Robert Koch Prize. He recently spoke with The Times.

What prompted you to start working on iPS cells?

In 2000, I became interested in how embryonic stem cells maintain their ability to develop into different kinds of cells. At the time, many laboratories were trying to turn embryonic stem cells into various functional cells. I thought the field was highly competitive, so I decided to go the opposite direction — [turning body cells] back to the embryonic state.

What advantages do iPS cells have over embryonic stem cells?

IPS cells can circumvent two obstacles faced by embryonic stem cells. One is the ethical controversy — we have to destroy embryos to isolate embryonic stem cells. The other is the risk of immune rejection when cells derived from embryonic stem cells are transplanted into a patient's body.

Do they have any disadvantages?

The safety of the cells. They are made by using retroviruses to introduce genes into mature cells, but the process can cause iPS cells to grow tumors if the retrovirus is inserted in the wrong part of the genome.

What is the long-term potential of these cells?

IPS cells can become an effective research tool for modeling drugs, screening drug compounds and testing for side effect or toxicity. In the future, when the safety and other issues are solved, iPS cell-derived functional cells may become sources for cell transplantation therapies.

What surprised you most about your research as it unfolded?

When our group succeeded in generating iPS cells, I never imagined so many researchers would begin working on this new technology — or that the research would advance at such a rapid pace.

What are the primary scientific hurdles that remain with iPS cells?

Scientists need to find out the methods to generate safer iPS cells, how to turn those cells into functional cells, and how to transplant resultant cells into a body. We also need to figure out how to use the cells to study diseases in the lab.

In the United States, the first clinical trial involving a therapy derived from human embryonic stem cells has just gotten underway. How do you feel about the pace of translating research into actual treatments?

The clinical trial using embryonic stem cells took a long time partly because use of the cells has caused an ethical controversy around the world. It is also true that it generally takes many years to turn basic research into clinical applications.

Some question why human embryonic stem cell research should continue when your discovery allows scientists to generate similar cells without destroying human embryos. What do you think?

Embryonic stem cells are still important for the development of iPS cell research. Findings from research on embryonic stem cells, such as methods to create various types of cells, have been applied to iPS cell research. That's why iPS cell research has evolved so rapidly. In addition, embryonic stem cells are used as control [comparison] materials when researchers conduct experiments on iPS cells and analyze their quality.

Many people speculate that you will win a Nobel Prize one day. Does that make it hard to get your work done?

I know some people have high expectations, but my concern is not thinking about winning a Nobel Prize. I worry about what I should do to bring iPS cell technology from the laboratory to the bedside as soon as possible.

eryn.brown@latimes.com

This interview was edited for clarity and space.

Research Carries Cautionary Warning For Future Stem Cell Applications

2010-11-24T14:30:00.000-08:00

Medical News Today
Nov. 24, 2010

Research work carried out at the Hebrew University of Jerusalem arouses a
cautionary warning in the growing field of the development of stem cells as a means
for future treatment of patients through replacement of diseased or damaged
tissues by using the patient's own stem cells. The research indicates a possible
danger of cancerous tissue development in the use of such cells.

Embryonic stem cells, which are undifferentiated cells, have the
potential to develop into all cell types of the adult body, and thousands of
researchers all over the world are working to develop the techniques which will
make possible their eventual application.

Research in the field has been
carried out initially using embryonic stem cells taken from human embryos.
However, a breakthrough occurred when, a number of years ago, Japanese
scientists succeeded in creating embryonic-like stem cells from mature human
cells through an induced "reprogramming" process. This made it possible to
obtain stem cells from a patient which can be used in his or her own treatment,
thus avoiding the possibility of cell rejection. These cells are called induced
pluripotent stem (iPS) cells.

In order for stem cells to be used in the
clinic, however, they must be raised in cultures for an extended period. During
this period, it has been observed that embryonic stems cells underwent
chromosomal changes, which included changes that characterize cancerous tumor
growth.

Research that has been carried out in the laboratory headed by
Nissm Benvenisty, the Herbert Cohn Professor of Cancer Research at the Silberman
Institute of Life Sciences at the Hebrew University of Jerusalem, has now shown
that the iPS cells also undergo abnormal chromosomal changes in culture.

Prof. Benvenisty, together with his post-doctoral fellow Yoav Mayshar
and his doctoral student Uri Ben-David, developed a new analytical method for
determining the genetic structure of the chromosomes in the iPS cells through
determining the cellular patterns of gene expression.

Each cell
generally bears two copies of each chromosome in the genome. The Hebrew
University researchers discovered that, in time, three copies of chromosomes
(trisomy) began to appear in the culture, and that the cells with the extra
chromosome were able to rapidly overpower the other, normal cells in the
culture. Such trisomies are present in abnormal tissue development, including
cancerous growths.

The researchers examined over 100 cell lines which
were published by 18 different laboratories around the world, in addition to the
iPS cultures raised in their own laboratory, and in this way were able to
solidly verify a great number of chromosomal changes in cell lines that until
now were considered normal.

In an article published in Cell Stem
Cell journal, the Hebrew University researchers have reported their
discovery. They noted that the chromosomal changes were not incidental, but
rather appeared systematically on chromosome 12 and involved up-regulation of
specific genes which reside on that chromosome. This discovery is liable to
hinder progress on the development of the use of human iPS cells in future
therapy because of the tumorigenic danger involved.

"Our findings show
that human iPS cells are not stable in culture, as was previously thought, and
require reassessment of the chromosomal structure of these cells," said Prof.
Benvenisty. "Also, our work shows for the first time the gene expression changes
that accompany these chromosomal aberrations found in the culture, paving the
way for our beginning to understand the mechanism by which these changes occur.

"The chromosomal changes in these iPS cells require everyone to exercise
great care in continuing to work with them, since these changes apparently will
influence the differentiation potential and the tumorigenic risk of these
cells."

According to Prof. Benvenisty, "The method we have developed for
identifying chromosomal changes through gene expression is likely to serve also
in other work involving analysis of different kinds of cells, including cancer cells. It is
relatively simple to use and enables one to observe the changes without having
to directly analyze the DNA of the cells." The discovery is patented by Yissum,
the Technology Transfer Company of the Hebrew University of Jerusalem, which is
currently searching for commercial partners for further research and
development.

Source: The Hebrew University of Jerusalem
Copyright: Medical News Today

FDA Approves Second Trial of Stem-Cell Therapy

2010-11-22T18:41:00.000-08:00

By Alice Park Monday, November 22, 2010 |
TIME Healthland

For only the second time, the Food and Drug Administration approved a company's request to test an embryonic stem cell-based therapy on human patients. Advanced Cell Technology (ACT), based in Marlborough, Mass., will begin testing its retinal cell treatment this year in a dozen patients with Stargardt's macular dystrophy, an inherited degenerative eye disease that leads to blindness in children. In July, the FDA released its hold on the first trial of an embryonic stem cell based treatment, for spinal cord injury.

ACT's trial will involve injecting retinal pigment epithelium (RPE) cells, which nurture the retina, into volunteers with the most advanced forms of Stargardt's, in an attempt to replace dying and no longer functioning photoreceptor cells. In animals, the infusion of healthy cells improved vision and rescued the function of some diseased cells.

Robert Lanza, ACT's chief scientific officer, is hoping that the company's RPE cells do the same in the patients, since the approval has been a long time coming. The company had initially submitted its request to begin human trials with its RPE cells in November 2009, but has spent the past year addressing the FDA's concerns about the safety of the embryonic stem from which the RPE cells are made.

The protocol involves injecting 50,000 to 100,000 RPE cells into the vitreous cavity of the eye. Because this region is protected from the body's ever-vigilant immune system, the new RPE cells do not have to be immunologically matched to the patients. But since they are made from embryonic stem cells, which can go on to become any of the body's various tissue types as well as form a type of tumor, the FDA was concerned that some pure stem cells would remain in the transplanted RPE population. Lanza says the company's scientists have developed an assay that can detect a single such stem cell from about one million RPE cells, a measure that satisfied the agency and may become a standard for future embryonic stem cell based treatments.

If successful, the treatment could be extended to address other degenerative eye diseases as well, including retinitis pigmentosa and macular degeneration. The healthy RPE cells could also be used in patients at earlier stages of these diseases, to prevent the degeneration before it starts.

For the moment, however, Lanza says the current study will be focused on establishing the safety of the RPE therapy, with any visual improvement a welcome bonus. “We're starting out with a safety study in those with advanced disease,” says Lanza. “But hopefully if we get in earlier in the progression of the disease we might see greater impact on visual improvement. What this approval shows is that the readiness of the FDA to work with researchers to move exciting new stem cell based therapies out of the lab and into the clinic.”

Is Genetic Research, Stem-Cell Therapy and Understanding DNA "Playing God"? - Vision.org

2010-11-17T17:51:00.000-08:00

A New Vision Article "In the Zone" Highlights the History of Genetic Research
Over the Last Five Decades

marketwire

PASADENA, CA--(Marketwire - November 17, 2010) - James Watson, co-discoverer
of the double helix structure of DNA in 1953, was once asked whether this
understanding leads to playing God. His infamous answer, "If we don't play God,
who will?" cuts to the core of the ethics of medical research, including the
development of stem cell-based therapies: How far should we go in seeking to
alleviate human suffering?

In the article In the Zone, Vision's Dan Cloer writes, "In whatever
light one views human beings -- whether our creative consciousness is the
byproduct of evolution or of being created 'in the image of God' -- we must take
responsibility for what we know. The hidden powers we have wrested from the
natural world are now our powers. It is an unfortunate foible of human
nature to lean toward expediency, so the need to walk with care is often
neglected, irrespective of underlying belief." Read
the full article.

Drawing from the 2003 report by the President's Council on Bioethics, Cloer
challenges readers to take a closer look at the stem cell issue: "Because the
choices made by some can, in their consequences, alter the shared life lived by
all, it behooves all of us to consider the meaning of these developments,
whether we are privately tempted by them or not" ("Beyond Therapy: Biotechnology
and the Pursuit of Happiness").

In an accompanying interview, "Just
Getting on with Business," Cloer speaks with stem cell researcher Clive
Svendsen about research ethics, scientific curiosity, and reprogramming stem
cells from adult body cells. "You have to be pragmatic in your approach, as well
as apply the best and most rigorous science that you can," says Svendsen,
director of the Cedars-Sinai Regenerative Medicine Institute in Los Angeles.
"There is one group of people that says, 'We need to know everything
about this before we can possibly touch a patient.' And another that says, 'I
don't care about anything; put the cells in, because the patient is dying.' I
say, let's have a rational plan backed up by statistical evidence that something
has an effect; but once we get to a certain point, let's proceed with that
'something' to a clinical trial."

Vision's "In the Zone" brings the reader up to date on current
directions in stem cell research and the ultimate goals of regenerative
medicine.

For more scientific health news visit http://www.vision.org

Getting It Right on Stem Cells

2010-11-11T19:31:00.000-08:00

Why hundreds of embryonic stem cell lines aren't enough

By Jeneen Interlandi
November 11, 2010
Scientific American

This fall funding for embryonic stem cell research once again faces uncertainty. In August a federal district court judge blocked the use of federal funds for any project that would destroy embryos. In September a higher court restored funding temporarily, while it considers an appeal by the Justice Department. We offer a guide to the facts behind the controversy:

Where do the embryos used for stem cell lines come from?
All stem cell lines come from discarded IVF embryos. Currently there are around 400,000 embryos stored at fertility clinics around the country.

How many stem cell lines are there?
A stem cell line is a family of constantly dividing cells produced from a group of parent cells that were harvested from a single embryo. M. William Lensch, a scientist at the Harvard Stem Cell Institute, estimates there are 800 lines around the world.

Why isn’t this enough?
In theory, one stem cell line can supply an infinite number of researchers indefinitely. But despite their omnipotent potential, embryonic stem cells are a finicky lot. Some have a tendency to grow into liver cells, others into blood, and others into nerve, pancreas or heart tissue. Sometimes the differences are caused by known factors, such as embryo age or protein contamination, but more frequently they are not understood. “For some projects, existing lines work very well, but for others, not at all,” Lensch says.

Why aren’t more unused embryos made into cell lines?
Whereas some 60 percent of infertility patients would like to donate their unused embryos to research, a dearth of funding and an uncertain regulatory environment have muddied the process. “Everything is at a standstill right now,” says Elena Gates, director of the IVF tissue bank at the University of California, San Francisco.

Are Embryonic Stem Cell Treatments Outside the U.S. Safe?

2010-11-10T18:47:00.000-08:00

By: Casey J. Bortnick

11/09/2010

YNN Your News Now, Rochester

Embryonic stem cell therapy is only available in clinical trials in the United States. Religious concerns and efforts to block funding for stem cell research have sent thousands of patients seeking this treatment overseas. While many in America's medical community warn these types of treatments are untested and dangerous. One man says it's keeping him alive.

"Theoretically I should be gone," said Derek Van Wyk.

For six years Van Wyk's been fighting ALS or Lou Gherig's disease. Those diagnosed with ALS have a life expectancy of 3-5 years. There is no cure.

"Some people bow down and accept it. I won't," Van Wyk said.

To extend his life Van Wyk put his faith in a controversial treatment and a doctor thousands of miles away.

"At least they're trying. Around here you get nothing," Van Wyk said.

Van Wyk went to India to undergo embryonic stem cell therapy.   He the cells injected into several parts of his body including his arms, legs, and the palms of his hands.

"The major procedures are in your epidural. In your spine," Van Wyk said.

Van Wyk said it’s working by stabilizing his condition and in some cases reversing his symptoms. The American medial community remains skeptical.

Dr. Mark Noble, of the University of Rochester Medical Center, has been studying the potential use of stem cells for more than 30 years. He believes this research will eventually provide new treatments for ALS, Parkinson's disease and spinal cord injuries. But, he warned, some doctors overseas are cutting corners.

"Virtually none of these treatments in overseas clinics have been documented. We don't know what the rules are over there yet. So there's a huge concern that people might go to these clinics and have a procedure that actually makes them worse," said Noble.

Van Wyk is convinced he's not getting worse. To much so he's willing to spend $15,000 a treatment.
"I, at the very minimum, bought myself two years," said Van Wyk.

Van Wyk recently returned home from his second trip to India. Friends and family threw him a welcome home party. He’s happy to be back spending time with his kids. Moments that remind him why he's fighting so hard.

"If you were to tell me everything would give you one more day with your kids. I’d do it. And I think most parents would,” Van Wyk added.

Van Wyk will return to India in another six to eight months for continued treatment. Van Wyk has already set aside money for his kids’ future, so he’s relying on fund raising events and donations from the community to cover his ongoing medical costs. For more click the link below.

Derek's Fight

Scientists to Congress: Pass the stem cell law ... while you still can

2010-11-08T13:03:00.000-08:00

By Karen Kaplan, Los Angeles Times

November 5, 2010

The people who bring you advances in medical research have an urgent message for Congress: Pass the Stem Cell Research Advancement Act … while you still can.

In a letter sent Friday to the leadership of the House of Representatives and the
Senate, the deans of American medical schools, chief executives of U.S.
hospitals and heads of organizations with names like the American Society for
Biochemistry and Molecular Biology and the American Society of Human Genetics
said that federal funding for human embryonic stem cell research “is essential”
if scientists are to succeed in turning the cells into usable
treatments.

“The therapeutic potential of human embryonic stem cells is
remarkable and could well prove to be one of the most significant
paradigm-shifting advances in the history of medical science,” they wrote.
“These cells have the unique potential to differentiate into any human cell type
and offer real hope of life-affirming treatments for diabetes, damaged heart
tissue, arthritis, Parkinson's, ALS and spinal cord injuries, to name but a few
examples.”

RELATED: Obama to reverse embryonic stem cell research policy

The law would reiterate that no federal money can be used to destroy embryos or create
cell lines. One of the pluses of passage is that it would ensure that the
controversial research be conducted according to strict ethical rules.

The bill has been passed twice before by bipartisan Congresses,
though in both cases it was vetoed by then-President George W. Bush. The
imperative to pass it in this congressional session was thought to have
diminished after President Obama broadened the scope of federal support for stem cell research though an executive order. Then the surprise decision by a U.S. district judge to halt federal funding of embryonic stem-cell research (which was temporarily
reversed) underscored the need for congressional action.

And if that’s going to happen, there’s no time like the present.

The scientists don’t say so explicitly, but they must be thinking that their chances will be
worse come January, when majority control of the House shifts to the Republicans. Here’s what they did say:

“We urge you to put this legislation on the floor calendar and pass it when Congress returns in November to help ensure the potential of this research is translated into treatments and cures.”

RELATED: Ruling a blow to stem cell research

Cord Blood America Praises Congress, President, for Reauthorizing Umbilical Cord Blood Stem Cell Collection Legislation

2010-11-05T12:57:00.000-07:00

Press Release
Source: Cord Blood America, Inc.
Friday November 5, 2010

LAS VEGAS, Nov. 5 /PRNewswire/ -- Cord Blood America, Inc. (http://www.cordblood-america.com) (OTC Bulletin Board:CBAI.ob - News), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, said today that it is pleased that Congress has approved, and President Obama has signed, the Stem Cell Therapeutic and Research Reauthorization Act of 2010.

U.S. Senator Jack Reed (D-RI), co-sponsor of the bill, said: "Cord blood is the blood that remains in the placenta and in the attached umbilical cord after childbirth. It is collected because it contains adult stem cells, which can be used to treat a range of diseases." He stressed that the bill will "help thousands of patients suffering from diseases requiring bone marrow and cord blood transplants."

Congressman Chris Smith (R-N.J.), who wrote the original bill in 2005, said, "It remains one of the best kept secrets in America that umbilical cord blood stem cells are curing people of a myriad of terrible conditions and diseases. Umbilical cords are a rich, non-controversial source of stem cells, yet hospitals throw millions of them away each year. This law created a new nationwide umbilical cord blood stem cell program designed to collect, derive, type and freeze cord blood units for transplantation into patients to cure serious diseases such as childhood leukemia."

Matthew Schissler, co-founder, CEO and President of Cord Blood America, said Rep. Smith, in moving to reauthorize the stem cell collection, stressed that research is ongoing to use these cells to do "miraculous things" in the treatment of cerebral palsy, lupus, and genetic diseases including Krabbe disease, Hurler disease and Tay Sachs disease.

"We believe there is a place for both public and private storage of umbilical cord blood stem cells and we salute Congress and the President for recognizing this important fact," Mr. Schissler said.

About Cord Blood America

Cord Blood America is the parent company of CorCell, which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Its mission is to be the most respected stem cell preservation company in the industry. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and potentially life-saving resource for treating a growing number of ailments, including cancer, leukemia, blood, and immune disorders. To find out more about Cord Blood America, Inc., visit our website at http://www.corcell.com/. For investor information, visit http://www.cordblood-america.com/.

CONTACT:
Paul Knopick
E & E Communications
949/707-5365
pknopick@eandecommunications.com

Conference Displays Stem Cell Research From Across Nation

2010-11-03T19:29:00.000-07:00

Research covers facets of skin and hair disorders, hearing loss, and disease treatment

November 3, 2010
By Yusnier Sonora Lopez

The Cornell Daily Sun

“Hearing loss is highly prevalent in our population – certainly something we all begin to experience with age, but I always tell my students: be careful about turning up the volume to high on your iPod. Damage to auditory cells in humans and mammals … is irreparable.” These were the opening words of a speech given by Prof. Andrew Bass, neurobiology and behavior, at the Third Annual Stem Cell Symposium held on Oct. 30. Bass concluded by saying that stem cells are just clearly beginning to make an impact on research to improve hearing loss.

The conference’s opening remarks were given by David Anders, New York State Stem Cell Science (NYSTEM) scientific officer. Dr. Anders explained that NYSTEM was implemented in 2007 with $600 million and an 11-year commitment to advance scientific discoveries in stem cell biology. The mission of the program is “to foster a strong stem cell research community in New York State and to accelerate the growth of scientific knowledge about stem cell biology and the development of therapies and diagnostic methods under the highest ethical, scientific and medical standards for the purpose of alleviating disease and improving human health.”

The morning session of the conference began with Prof. Richard Young, biology, MIT. Young is a member of the Whitehead Institute for Biomedical Research, and his work examines how protein regulators control gene expression in healthy and diseased cells. Dr. Young’s lab discovered that “embryonic stem cell master transcription factors form an interconnected autoregulatory loop, and thus feedback regulates their own expression.”

Young’s research is based on the concept that defects in gene expression can cause several chronic diseases, including “diabetes, cancer, hypertension, immune deficiencies and neurological disorders. Improved understanding of this circuitry should lead to new insights into disease mechanisms and the development of new diagnostics and therapeutics.”

Dr. Angela Christiano, the director of the Center of Human Genetics at Columbia University, discussed the application of stem cell technologies to skin and hair disorders.

Christiano studies genes that cause diseases through modeling a knockout of the gene in mice to test the effect of the gene. She discussed how Induced pluripotent stem (iPS) cells – cells with the potential to differentiate into multiple types of tissue – can be generated from an individual human dermal fibroblast.

The basic use of this technology has been around for about 30 years, explained Christiano – this is the same principle used to grow in vitro skin for patients with large burns. However, in her research, Christiano used this technique to grow keratinocytes – the predominant cell type in the epidermis – for patients. Her work examined genetic disorders that cause blistering of the skin by identifying their genes and finding the threshold expression at which the skin disorder would manifest. Christiano’s work has also lead to the discovery of several key genes involved in hair growth.

Following the morning session, 19 students from the University presented their work at a poster session. Samantha J. Palmaccio ’11 presented her poster, “Reconstruction of the MIR-376B-CIAP1 Pathway Targets Mammary Cancer Stem Cells,” which focused on “tumor-initiating, tumor propagating or cancer stem cells representing a subpopulation of highly tumorigenic. self-renewing cells believed to be largely responsible for tumor formation and progression in a broad variety of cancers.” The discovery of such cells is of vital importance since they are able to form carcinomas earlier and are able to reconstitute all tumor cell populations more efficiently, explained Palmaccio.

In the afternoon, Prof. Amy Wagers, stem cell and regenerative biology, Harvard University, presented on skeletal muscle stem cells in the muscle pepair and muscle disease. Her research focuses on “defining the factors and mechanisms regulating the migration, expansion and regenerative potential of blood-forming and muscle-forming stem cells.”

Prof. Alexander Nikitin, biomedical sciences, also presented his work. He is leader of the University’s stem cell research program. His work revealed that “both carcinomas and sarcomas associated with deficiency of tumor suppressor genes p53 and Rb arise from the stem cell compartment.”

Nikitin and Prof. Julien Sage, genetics, Stanford, both presented research that showed a side of stem cells applications that had not been investigated before. Stem cells have always been the center of fighting disease because of its applications to tissue regeneration. Now, these scientists have discovered that stem cells are involved in much more than creation and regeneration of healthy tissues; they are also involved in the originations of malignant ones.

Tudorita Tumbar, molecular biology and genetics, was chair of the Stem Cell Symposium Committee. Tumbar explained that the participants of the symposium were selected because they represented the leading edge of their field. Tumbar explained that it is important for the University to see what other people on campus and around the country are doing.

INDIA SOARS AHEAD OF NORTH AMERICA AND EUROPE, FAR AHEAD, IN STEM CELL RESEARCH

2010-10-30T14:37:00.000-07:00

RSCI Newsletter
Don Margolis
don@repairstemcells.org
http://www.repairstemcells.org/
Dallas, Texas
Bangkok, Thailand

While press release stem cell medicine is all that is available in the developed world ---fully controlled by Pharma---India is actually treating people. Our bribed politicians and corrupt scientists tell us to wait for embryonic stem cells, which they know will never be available during the lifetimes of today’s patients. Meanwhile, the world’s two largest countries, China and India, just keep improving patients’ lives, a concept that has been COMPLETELY lost in the West.

BANGALORE: While stem cells have been making news around the world for their potential, and are even being tried on patients, Dr N K Venkataramana, neurosurgeon, BGS Global Hospital in Bangalore, has successfully used the therapy on patients suffering from Parkinson's disease, Alzheimer's, cerebral degeneration and cerebral palsy.

"I used adult mesenchymal stem cells derived from the bone marrow. They were transplanted into the brain through keyhole surgery. These stem cells multiply and thereby regenerate the damaged areas of the brain. This leads to reactivation of brain cells, resulting in recovery from the disease," Dr Venkataramana explains.

It is for the first time that stem cells have been used in the treatment of Parkinson's disease in India, and has been published in a peer reviewed journal for the first time ever.

HALT TO DEGENERATION

Such degenerative diseases of the brain have no cure so far, and are progressive. They ultimately lead to disability of the patients. "I have used this therapy on over 40 patients so far and in all of them, progression of the disease has ceased. This is the first benefit. Now, the process of their returning to normal will begin. In about six months to one year, I expect them to be near normal."

In all these cases, the brain cells die prematurely, leading to loss of neural network and secretion of neuro transmitters. These are needed for the different actions and controls of the body. With the cells dying, these actions are inhibited, leading to permanent disability.

"I was moved by the plight of my patients and their families. I had to tell them there was no hope of a cure and all that we had was symptomatic treatment. I was taught in medical school that the brain could never be regenerated. Now, this has been proved wrong by medical science," says Dr Venkataramana.

COMPLETE CURE? NOT QUITE YET……

Thus began his quest to find a cure by regenerating brain cells. He created a state-of-the-art research facility -- Advanced Neuro Science Allies -- and began his research into the use of stem cell therapy three years ago. "I picked out authentic mesenchymal stem cells from bone marrow using a marker. The stem cells were purified and tried on animals for safety. Subsequently, we used the therapy on patients," he says.

The results have been more than encouraging. "Initially, the findings are that we are on the course to a complete cure. All the patients treated so far have a marked decrease in the need for medication. Their symptoms have reduced drastically. They have an increased feeling of well-being and it is obvious that they are recovering. However, there are still some factors to be addressed and understood."

Does this mean a change in the way Parkinson's disease, Alzheimer's, cerebral palsy and other brain degenerations will be treated in future? "Definitely. Conventionally, such intervention is recommended at the dead end of the disease's progression, when the maximum damage has happened. Ideally, this therapy should be provided at the earliest as recovery is quicker and better from the beginning, and chances of the patient becoming normal are more," Dr Venkataramana says.

The most encouraging results have been with children suffering from cerebral palsy. "They have shown significant recovery in their cognitive and physical abilities," he says. This promises to be the beginning of a new era in neuro sciences.

Read more: Stem cells revive dying brains - The Times of India

http://timesofindia.indiatimes.com/city/bangalore/Viva-Stem-cells-revive-dying-brains/articleshow/6811649.cms#ixzz13Q3Giyym

FROM DON MARGOLIS:

Throughout the infancy of Repair Stem Cell therapy, we have tried to repair brain damage by injecting the cells into the spinal canal, hoping they will make it to the inflamed/deprived brain cells and repair them. But the older the patient, the worse the blood-brain barrier is, resulting in poor (less than 50%) results for older folks. We now have two centers who have proven that stem cells into the brain are the answer for advanced MS and Parkinson’s. Let us know if you wish more info.

Lab concerned stem cell lines could be wasted

2010-10-25T15:25:00.000-07:00

Friday, October 22, 2010
ABC 7 News
Healthbeat
By Sylvia Perez

October 22, 2010 (CHICAGO) (WLS) -- The first human trials of embryonic stem cells are now under way.

A private genetics lab in Chicago claims to be one of the world's largest holders of stem cell lines. But the lab has been denied federal funding. The lab is concerned that many of these lines will now go to waste.

The Reproductive Genetics Institute is a private lab in Chicago that for decades has created human embryonic stem cells marked with different diseases. The hope was some 47 stem cells lines they have collected could be used as government research to combat illnesses such as muscular dystrophy and Huntington's disease.

But this past summer, a federal health panel denied RGI funding because of concerns about some legal language used in their consent forms.

RGI believes its lines could give scientists insight into the way genetic defects develop and how they can be treated.

"We have over 400 different embryonic stem cells lines, of which about 100 are with different genetic disorders, and all others are normal embryonic stem cell lines," said Dr. Anver Kuliev, RGI director of research.

The lines come from embryos for in vitro fertilization that were not used and donated.

The lab helped establish what is known as pre-implantation genetic diagnosis. That's where a couple's embryos can be checked for mutations before being implanted.

RGI says the embryos would have been destroyed anyway.

The lab also says patients were not compensated in any way for these embryos. It adds it cannot donate these stem cells lines to any other institution because they would still need government funds to work with these lines.

So, in the meantime, the lines will remain frozen and could eventually be discarded.

Opponents say extracting cells from embryos is a destruction of human life and should not be allowed or supported with federal research dollars.

(Copyright ©2010 WLS-TV/DT. All Rights Reserved.)

Stem cell research: a new age dawns in healthcare

2010-10-19T14:50:00.000-07:00

Scientists working in stem cell research believe that they are about to change medicine forever, writes Michael Day.

By Michael Day
Published: 10:04AM BST 19 Oct 2010
Telegraph.co.uk

Professor Pete Coffey, of University College London, like many other stem-cell scientists, has a spring in his step these days. His team is set to conduct the first test of an embryonic stem cell-based treatment on patients in the UK.

Approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to test a therapy that he hopes will cure macular degeneration, the most common form of blindness among older people in the western world, is unlikely before 2012. However, Prof Coffey is confident that the regulator will give the go-ahead.

This is due in no small part to events in the US, where it was announced last week that doctors had begun the first trial in which patients with spinal-cord injuries will receive tissue grown from human embryonic stem cells.

The study by the Geron Corporation is primarily designed to test the safety of the procedure; larger trials will be needed to gauge its effectiveness. But the fact that the US Food and Drug Administration approved the trial is testimony to important advances in stem-cell research.

The progress has been hard-won. The alarm sounded in 2001 when foetal tissue presumed to contain stem cells was implanted into the brains of Parkinson's patients in New York, in the hope they would colonise the brain with cells that produce dopamine, a brain chemical that is depleted in Parkinson's. In the event, it produced side-effects described by the researchers as "disastrous": the cells spread out of control and the patients suffered horrific problems, their muscles jerking uncontrollably.

Subsequent warnings included one from Cornell University researchers that showed stem cells could also generate precancerous cells.

Considering what embryonic stem cells actually are, the risks of introducing them directly into patients is not surprising. These undifferentiated master cells that emerge a few days after conception have the potential to become any of the 200 or so cell types in our bodies. However, they share with some cancer cells the property of "immortality".

This means the end parts of their chromosomes (telomeres) are continually replenished. In normal cells, telomeres wear away with age – a process that eventually prompts older cells, which are more likely to have suffered dangerous genetic damage, to die. "Scientists have learnt the lesson," says Prof Coffey. "Researchers make sure the cells are differentiated into normal tissue before giving them to patients. That's what we're doing. That's what the Geron people are doing, and what all the other research groups will do. The possibility of tumour-genesis [the formation of cancer] just isn't there now."

The other important change is political. With George W Bush out of the White House, the US, the world's powerhouse for biomedical research, is once more publicly funding medical research with embryonic stem cells left over from fertility treatments.

The Geron scientists have grown oligodendrocyte precursor cells from their stem cells. They hope that, once injected at the site of recent spinal injury, these will populate the area and help regenerate damaged tissue.

Prof Coffey's group is using stem cells to develop cells that support the retina, the photosensitive area at the back of the eye. In patients with macular degeneration, these cells start to disappear. He hopes that a patch containing the reared cells delivered behind the retina will restore patients' vision. "If we start testing, we should know quite quickly whether it works. The question is simple: can the patients see again?"

He believes treatments for conditions like macular degeneration, which are well-understood and don't require complex interactions between curative cells and host tissue, will be the first to appear. "Liver disease, heart conditions, perhaps diabetes, where the concept of getting insulin-producing cells into the body is quite simple, might be the first to be treated."

He predicts stem-cell treatments for more complex and less well-characterised conditions, including brain diseases like Alzheimer's or Parkinson's, will take longer to appear. But ultimately he is in no doubt that stem cells "will change medicine for ever".

This is a view shared by his UCL colleague Chris Mason, professor of regenerative medicine bioprocessing. "There are still many years of rigorous testing ahead and there will be setbacks and failures before we have safe and effective cell-based therapies,'' he says. "But this first in man [Geron] study marks the dawn of the 'Stem Cell Age'."

Hope for spinal cord patients

2010-10-18T14:31:00.000-07:00

The latest in how human embryonic stem cells are being put to use to treat spinal cord injuries and other debilitating conditions.

Los Angeles Times
By Jill U. Adams, Special to the Los Angeles Times
October 18, 2010

History was made this month when a patient in Atlanta was treated for the first time with a therapy derived from human embryonic stem cells. It was part of a clinical trial to test the safety of specialized nerve cells that researchers hope will repair damaged spinal cords — potentially allowing patients to regain the use of their legs, bladders or even just a single finger that would allow them to operate their own wheelchair.

There is currently no cure for the paralysis that results from a traumatic spinal cord injury. And while the world watches this trial, researchers say no one should expect it to produce a miracle cure.

"There's so much hype about stem cells," says Dr. Michael Sofroniew, a neurobiologist at UCLA's David Geffen School of Medicine. "Yes, there's enormous potential there, but we have to approach it in a realistic way."

An estimated 262,000 Americans are living with some degree of paralysis as the result of a spinal cord injury. An additional 10,000 to 12,000 suffer irreparable damage to their spinal cords — most commonly due to car crashes, but also from violent attacks, falls and sporting accidents — each year, according to the National Spinal Cord Injury Statistical Center.

Here's a closer look at how human embryonic stem cells are being put to use to treat spinal cord injuries and other debilitating conditions.

What is spinal cord injury?

The spinal cord is the major highway for nerve cells that relay information between the body and the brain. The cord is protected by the vertebrae of the spine, but a blow to the back or neck can cause the cord to bruise or tear. How much function a person loses depends on which part of the cord is affected, along with how many and which nerve fibers are damaged.

The original trauma to the nerve cells can strip them of their insulating sheath of fat and protein called myelin. Without myelin, a nerve's ability to conduct an electrical impulse is severely impaired. "It's the difference between being able to transmit and not being able to transmit," says Hans Keirstead, the UC Irvine neuroscientist who invented the embryonic stem cell therapy now being tested in Atlanta by Geron Corp. of Menlo Park, Calif.

Over time, a secondary degeneration occurs, in which damaged fibers slowly die. The stem-cell therapy addresses both of these processes, Keirstead says.

How are human embryonic stems cells used as therapy?

The cells are grown in the laboratory and treated according to a specific biochemical regimen that encourages them to develop into a kind of nerve cell called an oligodendrocyte progenitor cell. These cells help an injured spinal cord in two ways: They restore the necessary myelin, and they release loads of growth factors that nurse the tissue and prevent secondary loss of neurons.

In experiments with rats, the oligodendrocyte progenitor cells improved the animals' ability to walk, and even run with a limp, after injuries to the thoracic (midbody) and the cervical (neck) spinal cord. The researchers also found that more myelin and more neurons were saved in treated animals. Keirstead's team published these results in a 2005 Journal of Neuroscience study and a 2010 paper in the journal Stem Cells.

Who is eligible to enroll in the Geron trial?

For now, scientists are focusing on injuries that are no more than two weeks old and have the best odds of being reversed with proper treatment. But they don't want patients whose injuries are less than one week old because the body's natural healing process could damage the therapeutic cells.

In addition, the clinical trial is testing only thoracic injuries, because if the cells don't work — or worse, cause harm — the outcome would be less severe than with cervical injuries. "Close to your neck is your brain stem, which controls your heart rate, your breathing and your temperature regulation," Keirstead says. "You mess with that and you die."

Why use embryonic stem cells instead of other types of cells?

Theoretically, scientists could try to create a cell-based therapy that starts with adult stem cells or fetal-derived stem cells, or they could attempt to grow mature oligodendrocytes in the lab. However, Keirstead says, "you can't get enough, and then the ones that you get don't divide well." Embryonic stem cells, on the other hand, divide like crazy and can be used to make enough of the therapy to treat a patient.

How are spinal cord injuries usually treated?

The standard treatment usually includes surgery to decompress the injury site and stabilize the spinal cord, says Dr. Robert Grossman, chairman of neurosurgery at Methodist Hospital in Houston, who is leading a clinical trial of a neuroprotective drug called riluzole for the New Jersey-based Christopher and Dana Reeve Foundation.

In addition, a variety of treatments are aimed at addressing the many things that go wrong after a spinal cord injury. For example, drugs and hypothermic treatment administered early on may help protect against neuron loss and control inflammation.

Following that, patients receive sophisticated exercise programs to try to regain lost mobility. Treatments that trigger small improvements in neuron growth may be enhanced by training regimens. "There's more capacity for plasticity and reorganization in the nervous system than was appreciated 20 years ago," UCLA's Sofroniew says.

Other experimental treatments are also being developed to stimulate regeneration of myelin and nerve connections. For example, an antibody called anti-Nogo was found to be safe in a clinical trial. The next step is to test its effectiveness, according to a review paper published this year in Annals of the New York Academy of Sciences.

How will the success of the stem-cell trial be measured?

This is a safety study that will enroll no more than 10 patients and follow their neurological condition for one year. In addition, researchers will be watching closely to see whether the cell-based therapy causes tumors or pain. Tumors can result from transplants containing undifferentiated stem cells, which have been purified out of the Geron product, but it's still a theoretical risk, Keirstead says. Pain could occur if the oligodendrocyte progenitor cells trigger the branching of pain fibers within the spinal cord.

If safety is confirmed, Geron would proceed with a Phase 2 trial designed to gauge the cells' effectiveness in repairing spinal cord injuries.

What other diseases might benefit from embryonic stem cells?

At least one other company has asked the U.S. Food and Drug Administration for permission to proceed with clinical trials of a therapy derived from human embryonic stem cells. Santa Monica-based Advanced Cell Technology Inc. wants to test its lab-grown retinal pigment epithelium cells in patients with a rare eye disorder called Stargardt's macular dystrophy, a childhood version of macular degeneration.

In the long run, embryonic stem cells could be used to develop treatments for other neurodegenerative diseases, such as Parkinson's disease and multiple sclerosis. "We're embarking on a completely new approach to medicine," Sofroniew says.

health@latimes.com
Copyright © 2010, Los Angeles Times

Embryonic stem cell research under way

2010-10-16T19:10:00.000-07:00

Reporter - Todd Faulkner
Photojournalist - Jason Thomason
Oct 13, 2010
Local 6 News WPSD

PADUCAH - There is new hope for millions of people who are paralyzed because of spinal cord injuries.

For the first time in the United States, there is a clinical trial using embryonic stem cells on humans. The study is enrolling patients who recently suffered a spinal cord injury. Stem cells will be injected into the patients' spines.

The first patient to enroll is in Atlanta, but the study will take place at seven sites across the country. Doctors said the trial will last about two years.

Scientists are testing whether the therapy is safe, not if the therapy actually works. The hope is one day embryonic stem cells might restore feeling to damaged spinal cords making it possible for people who are paralyzed to walk again.

Cary White, of Lone Oak, loves life and keeps a positive outlook despite his condition as a C5 quadriplegic.

"You could sit and lay in bed if you wanted to but I just choose not to," White said.

A diving accident in 1988 confined the now 42-year-old to a wheelchair.

This week marks new hope as doctors started injecting human embryonic stem cells into people partially paralyzed by a spinal cord injury, like White.

"It's very encouraging," White said. "Do I get my hopes up that it's going to happen? No. If it happens that would be great but I'm going to continue living my life as I do now."

That includes not only owning his own business but also serving as Lone Oak Middle School's football coach. While he supports embryonic stem cell research, he understands it sparks controversy.

"(The United States) has the money. We have the money. People would love to donate money for research but then you get it blocked because of the controversy and that's what's so frustrating about the whole thing," White said.

It's something he thinks about while he continues living life: how one day the research might help him and millions of others.

"I just think there could be more people knowing that it's not just going to benefit paralysis. It's going to benefit so many other different diseases."

Embryonic stem cells have been a topic of debate and have been subject to funding restrictions. The company conducting the trial, Geron, did not use federal funds.

First Patient Has Experimental Stem Cell Procedure

2010-10-11T22:08:00.001-07:00

AOL News
October 11, 2010

(Oct. 11) -- A patient suffering from a spinal cord injury has become the first recipient of an experimental, and highly controversial, human embryonic stem cell treatment.

Geron Corp., the biopharmaceutical group behind the phase I clinical trial, made the groundbreaking announcement earlier today.

The company is the only one to have FDA approval for human embryonic stem cell trials.

Little information about the patient has been released, but the Geron trial is designed to test the safety of embryonic stem cell therapy for newly sustained thoracic spinal cord injuries.

"Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies," Thomas B. Okarma, Geron's president and CEO, said in a press release.

Seven institutions are participating in the trial, which will also monitor the effectiveness of the therapy. The first patient is being treated at the Shepherd Center, an Atlanta hospital dedicated to brain and spinal cord injuries.

The stem cells used in the procedures are harnessed from leftovers of fertility treatments. Doctors hope the stem cells will help nerves in a newly damaged spinal cord regenerate.

Sponsored Links Geron's announcement comes at a particularly tenuous time for stem cell research, with dozens of projects halted after a federal ruling that in August undercut government funding for many initiatives in the field.

"This decision has just poured sand into the engine of discovery," NIH Director Francis Collins told The Associated Press after the ruling.

But while many federally funded projects have been stalled, Geron's work is privately funded -- meaning the company's trial will continue even as legal debates persist.

And in an effort to fast-track stem cell therapies, other scientists are investigating alternatives. Earlier this month, scientists in Boston reported exciting progress in turning skin cells into stem cells.

Embryonic Stem Cell Research Receives Widespread Support From Americans

2010-10-08T21:28:00.000-07:00

Recent poll finds 72% of adults surveyed believe research has merit

Press Release Source: Harris Interactive
Thursday October 7, 2010

NORWALK, Conn., Oct. 7 /PRNewswire/ -- A large majority of Americans across various demographic groups agree that scientists should be able to use stem cells for biomedical research, according to a recent Harris Interactive/HealthDay poll.

(Logo: http://photos.prnewswire.com/prnh/20100518/NY06801LOGO )

(Logo: http://www.newscom.com/cgi-bin/prnh/20100518/NY06801LOGO )

Almost three quarters of adults surveyed are in favor of using embryonic stem cells left over from in vitro fertilization procedures to search for potential prevention or treatment of diseases such as Parkinson's disease, Alzheimer's, diabetes and other conditions. These poll results remain consistent with a similar survey released in 2005.

This poll took place at a critical juncture in legal arguments surrounding stem cell research in the United States. Recently, U.S. District Court Judge Royce Lamberth ruled that federal funding of embryonic stem cell research violated a 1996 law prohibiting the use of taxpayer dollars for such work. The Obama administration appealed that decision. Soon after, an appeals court issued a temporary suspension of the ban until it could hear full arguments over the next few weeks.

"There is now overwhelming public support for using embryonic stem cells in biomedical research," said Humphrey Taylor, chairman of the Harris Poll, a service of Harris Interactive. "Even among Catholics and born-again Christians, relatively few people believe that stem cell research should be forbidden because it is unethical or immoral."

Paul Sanberg, distinguished professor of neurosurgery and director of the University of South Florida Center of Excellence for Aging and Brain Repair in Tampa, said, "This [poll] shows that the public still believes that stem cells could lead to important therapeutics."

The poll was conducted online between Sept. 28-30 and included 2,113 adults ages 18 and over. Among its other findings:

•Seventy-three percent (versus 72 percent in 2005) believe that stem cell research should be allowed "as long as the parents of the embryo give their permission, and the embryo would otherwise be destroyed."
•Fifty-eight percent of Republicans think stem cell research is acceptable (versus 24 percent opposed), as do 69 percent of Catholics and 58 percent of born-again Christians. Sixteen percent of Catholics and 22 percent of born-again Christians oppose it.
•Two-thirds of the respondents agreed that, "If most scientists believe that stem cell research will greatly increase our ability to prevent or treat serious diseases we should trust them and let them do it."

(Read the rest of this article by clicking on the link in this blog post's title above this post.)

New stem cell technique captures 'high moral ground'

2010-10-06T15:24:00.001-07:00

Posted on Oct 5, 2010 | by Staff
Baptist Press

WASHINGTON (BP)--Pro-life bioethicists have applauded the announcement of a new advance in stem cell research that is a safer and more efficient method than previously discovered methods and avoids experiments that destroy human embryos.

Scientists at the Harvard Stem Cell Institute in Boston, Mass., published studies showing they had reprogrammed adult skin cells into induced pluripotent stem (iPS) cells without the hazards previously associated with the technique. Unlike previous conversions of adult cells into stem cells virtually identical to those in embryos, these iPS cells did not require the use of viruses to insert genes into cells -- a technique which increases the risk of cancer in the recipient of the cells.

The new method also avoided the ethical problems of embryonic stem cell research (ESCR), which requires the destruction of days-old human embryos when extracting the cells.

ESCR opponents said the development further demonstrates the destructive research method -- which is funded by the federal government -- is not only morally repugnant but unnecessary.

"This is yet another confirmation that when science takes the moral high ground great discoveries can be made," said C. Ben Mitchell, professor of moral philosophy at Union University in Jackson, Tenn., and a consultant to the Southern Baptist Ethics & Religious Liberty Commission.

"Even some of the most skeptical proponents of embryo-destructive research are getting the message," Mitchell told Baptist Press. "There are no good reasons to kill human embryos for research. Human embryos belong in a mother's body, not in a research lab."

Richard Doerflinger told The Washington Post, "With each new study it becomes more and more implausible to claim that scientists must rely on destruction of human embryos to achieve rapid progress in regenerative medicine." Doerflinger is associate director of the Secretariat of Pro-Life Activities at the U.S. Conference of Catholic Bishops.

David Stevens, the Christian Medical Association's chief executive officer, said the new research "should put one of the final nails in the coffin of federally funded embryonic stem cell research. This breakthrough is further evidence that the government's illegal funding of embryo-destroying research is like investing in vinyl record technology in a digital age."

ESCR advocates, however, continued to call for government funds for destructive research using embryonic cells.

Francis Collins, director of the National Institutes of Health (NIH), commended the new study as "a substantial advance" but said the new iPS research must be compared to ESCR. "To explore these important potential differences, iPS research must continue to be conducted side by side with human embryonic cell research," he told The Post.

The discovery was announced as a battle over government funding of ESCR is being fought in the federal judiciary

Two days before the Harvard researchers issued their Sept. 30 report, the District of Columbia Circuit Court of Appeals ruled federal funding of ESCR may continue while a legal challenge is considered.

D.C. federal judge Royce Lamberth had halted the grants Aug. 23 because a lawsuit against NIH guidelines on ESCR had "a strong likelihood" of succeeding. On Sept. 7, Lamberth rejected the Obama administration's request that he revoke his stay. The administration then took its case to the appeals court.

In his injunction stopping funding of ESCR, Lamberth found NIH's 2009 guidelines violated a 1996 law that prohibits federal funds for research in which a human embryo is destroyed. NIH's rules allow funding for research on stem cells derived from embryos created by in vitro fertilization but not implanted. The embryos have to be donated by the parents who underwent the fertility treatments.

NIH published the guidance after President Obama issued an executive order earlier in 2009 overturning a more restrictive funding policy and ordering the institute to draft guidelines consistent with his decree. Obama's executive order overturned a prohibition instituted by President Bush on federal funding of stem cell research that results in the destruction of embryos. Bush's 2001 order permitted, however, grants for experiments on stem cell lines, or colonies, already in existence at the time of his action.

The ability of stem cells to convert to other cells and tissues has provided great hope for developing cures for various diseases.

ESCR is not only lethal to the embryo, but it has not proven as effective as other forms of stem cell experimentation that do not harm the donor. It has yet to provide any treatments for human beings and has been plagued by tumors in lab animals.

Embryonic stem cells are pluripotent, which means they, in theory, can convert into any type of cell or tissue. Adult stem cells are not. Yet, research with adult cells in human trials has produced therapies for 73 afflictions, including cancer, juvenile diabetes, multiple sclerosis, heart damage, Parkinson's, sickle cell anemia and spinal cord injuries, according to Do No Harm, a coalition promoting ethics in research.

Experiments with iPS cells using earlier methods since 2006 have demonstrated promising results and generated a great deal of interest among scientists. Their safety has been questioned because of the use of viruses, and their conversion also has been slow.

The Harvard team found its method was about twice as fast in converting the skin cells into iPS cells and as much as 100 times more efficient, according to The Post.

Instead of viruses, the researchers created molecules referred to as "messenger RNA" to produce proteins necessary for reprogramming the cells into iPS ones, The Post reported. The scientists also used the technique to convert the iPS cells into specific cells that may be used in transplants, according to the newspaper.

Stem cell researchers hailed the results.

"All I can say is 'wow' -- this is a game-changer," said Robert Lanza of Advanced Cell Technology (ACT) in Worcester, Mass., The Post reported. "It would solve some of the most important problems in the field."

Describing the method as "almost too good to be true," Lanza said, "The ability to safely and efficiently generate patient-specific cells has the potential to transform transplantation medicine."

The study was published in the journal Cell Stem Cell.

--30--

Compiled by Tom Strode, Washington bureau chief for Baptist Press.

New Stem Cell Technique Does Not Require Use Of Embryos

2010-10-04T18:17:00.000-07:00

Main Category: Stem Cell Research
Also Included In: Dermatology
Article Date: 04 Oct 2010
Medical News Today

Treating adult human skin cells with ribonucleic acid molecules is a reliable method for creating induced stem cells that have properties similar to embryonic stem cells, according to a study published on Thursday in the journal Cell Stem Cell, USA Today reports. Stem cell research has proved controversial over recent years because it often involves the destruction of embryos. In the new technique, RNA molecules are engineered to overpower immune system defenses and convert the skin cells into stem cells, which can then be grown into specific types of tissues, such as muscle.

In 2006, a team of researchers at Kyoto University reported success with a similar strategy that used viruses to spur the transformation of adult skin cells into embryonic-like stem cells (Vergano, USA Today, 10/1). However, that technique involved disrupting the DNA of the skin cells, which would expose any patients who received transplanted tissue to a risk of cancer. The revised technique -- studied by lead researcher Derrick Rossi of Children's Hospital Boston and the Harvard Stem Cell Institute and colleagues -- treats skin cells with messenger RNA molecules (AP/New York Times, 9/30). According to USA Today, the new method is 40 to 100 times more productive than the original method (USA Today, 10/1).

NIH Director Francis Collins praised the new research but added a note of caution, the Washington Post reports. Collins said, "The new report provides a substantial advance. But this research in no way reduces the importance of comparing the resulting ... cells to human embryonic stem cells."

Collins added that previous research on the new method showed that cells altered by RNA molecules "retain some memory of their tissue of origin, which may have important implications for their use in therapeutics." To address this question, he said, the RNA technique "must continue to be conducted side by side with human embryonic cell research" (Stein, Washington Post, 9/30).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.

© 2010 National Partnership for Women & Families. All rights reserved.

Stem cell research breakthrough

2010-10-04T18:14:00.000-07:00

3. October 2010
By Dr Ananya Mandal, MD
THE MEDICAL NEWS

Australian researchers have grown new human stem cells outside the body and this may provide new hope to cancer patients and those with genetic disorders. The team found a way to manipulate the environment of blood-forming stem cells to make them multiply. This will mean a lesser number of painful bone-marrow harvests needed for transplantation and also drastically increase the number of people able to use rare donations of blood taken from umbilical cords. Cell transfusions would also be possible for many severe genetic disorders say the scientists.

Lead researcher John Rasko, who is the head of gene and stem cell therapy at the Centenary Institute explained that stem cell transplants are vital in the treatment of cancer patients who have had their bone marrow destroyed by chemotherapy but the use is hindered by the difficulty of collecting sufficient amounts of cells. Usually only what is harvested can be transplanted to a patient, and any cells that die in the process are not replaced. In this new technique the team found that if the stem cells were placed on a unique stretchy surface called tropoelastin the number of cells would double or even treble. The material is a microscopic-thin and springy substance that mimics conditions inside the human body, and so can promote the growth of hemopoietic stem cells (HSCs) on a lab plate.

They have tried the technique in both mice and humans, but only mice have so far had the cells transplanted into their bodies. Professor Rasko said the new process could make “a very substantial difference” to the global availability of a “very precious and limited resource”. He added, “What we have shown, and discovered for the first time in the world, is that these rare and precious red blood-forming stem cells can sense their physical environment… And just like a cat on a sofa bed trying to find a comfortable spot, they can actually sense the springiness or elasticity of the bed they find themselves on… By recreating that elastic bed for the stem cells, outside of the body, we can cause those cells to double or triple in number and grow them outside of the body.”

The research was a collaboration of the Centenary Institute, the Royal Prince Alfred Hospital and the University of Sydney, and the results are published in the journal Nature Biotechnology. They are looking at human trials soon but say cancer therapy with this technique may take some more years.

Study shows progress with stem cell alternative

2010-09-30T17:24:00.000-07:00

By Malcolm Ritter
AP Science Writer / September 30, 2010

NEW YORK—Scientists reported more progress Thursday with a method of creating stem cells without using embryos.

The advance in cell reprogramming by researchers in Boston was praised as a more efficient way of turning skin cells into stem cells, a step toward developing new medical treatments. One expert said the new approach might be the first practical way to make such cells for creating new tissue to treat conditions like diabetes and Parkinson's disease.

In 2007, when scientists first reported they had reprogrammed skin cells into stem cells, it was hailed as an alternative to getting stem cells from embryos, which are then destroyed. Since then, researchers have been working on fine-tuning the method.

Embryonic stem cells, which have the ability to morph into any type of cell, continue to be controversial. Last month, a U.S. judge cut off federal funding for research with them. (A different court ruled Tuesday that funding could resume while legal arguments proceed.)

The reprogramming produces what scientists call iPS cells, for induced pluripotent stem cells.

The technology first used to make them involved disrupting the DNA of the skin cells. That method would introduce a risk of cancer to any patient who got transplanted tissue derived from the iPS cells. So researchers have been developing alternate methods.

The new approach is more efficient than earlier efforts and avoids tampering with DNA, said Derrick Rossi of Children's Hospital Boston and the Harvard Stem Cell Institute. He and his colleagues reported the work in a paper published online Thursday by the journal Cell Stem Cell.

Their technique treats skin cells with modified forms of RNA, a chemical cousin of DNA that normally transmits instructions from genes to the protein-making machinery of the cell. Rossi has patented the technique and formed a company to use it.

Experts unconnected with the study praised the work.

The method appears to be highly efficient, which implies the resulting iPS cells will be of good quality, said Marius Wernig, an iPS researcher at Stanford University.

It will take further work to see if the initial promise is borne out, Wernig said. If so, it would be the first practical method for generating iPS cells that could be used for transplant therapies, he said.

"If it turns out to be a very efficient way of generating iPS cells without any genetic modification, then it would be a big advance," Wernig said.

Kathrin Plath of the University of California, Los Angeles, called the work "very impressive" and said it appears to show the best approach so far for making such cells for transplant tissue.

"We will definitely try this method here at UCLA," she said in an e-mail.

Still, further study is needed to confirm the benefits of the new approach, she said.

------

Online:

Cell Stem Cell: http://www.cell.com/cell-stem-cell/home

Information on iPS cells: http://bit.ly/dvGaqN

© Copyright 2010 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Court: U.S. stem cell funding may continue

2010-09-29T14:43:00.001-07:00

Published: Sept. 28, 2010
UPI.com

WASHINGTON, Sept. 28 (UPI) -- An appeals court in Washington Tuesday permanently lifted a temporary injunction forbidding the U.S. government from funding human embryonic stem cell research.

The ruling by the U.S. Circuit Court of Appeals for the District of Columbia will allow federally funded research to go on while the Justice Department appeals a lower court ruling that such funding violates a federal rule prohibiting federal tax money from being used for research involving the destruction of human embryos.

White House press secretary Robert Gibbs issued a statement saying President Barack Obama "made expansion of stem cell research and the pursuit of groundbreaking treatments and cures a top priority when he took office."

"We're heartened that the court will allow NIH [National Health Institute] and their grantees to continue moving forward while the appeal is resolved," Gibbs said.

District Court Judge Royce Lamberth, whose August ruling blocked federal funding for such research, subsequently refused to delay his injunction while the Obama administration appealed his decision, CNN reported.

The ruling came in a lawsuit against the institute brought by a number of plaintiffs, including researchers who oppose the use of embryonic stem cells, a group that seeks adoptive parents for human embryos created through in vitro fertilization, and the non-profit Christian Medical Association.

© 2010 United Press International, Inc. All Rights Reserved.
Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

US appeals court hears debate on stemcell research

2010-09-27T16:13:00.001-07:00

– Mon Sep 27

WASHINGTON (AFP) – A US appeals court heard debate Monday over whether to suspend embryonic stem cell research funded by the government, as the Obama administration argued that a ban would waste millions of dollars already invested in scientific study.

For over an hour, three judges of the US Court of Appeals for the District of Columbia questioned Department of Justice lawyers who insisted that the public interest and the fight against deadly diseases would suffer permanent damage if the research is halted.

They also quizzed lawyers for two scientists working on embryonic stem cells, as well as for religious conservative groups which have challenged the use of public funds for research that leads to the destruction of human embryos.

"Research for years would be irreparably harmed," said Beth Brinkmann of the Justice Department.

She was responding to skepticism voiced by Judge Thomas Griffith, appointed by president George W. Bush, over the possibility that the total amount invested to date -- hundreds of millions of dollars -- would be completely lost if the ban were upheld.

Stem cells -- so named because they are the foundation for all human cells -- are seen by many scientists as crucial in the treatment of diseases like diabetes, Alzheimer's and Parkinson's.

President Barack Obama authorized the renewal of federal funding in March 2009, reversing a ban imposed by his predecessor Bush in 2001 on moral and religious grounds.

But the issue has again been at the center of a political firestorm since late August, when a judge ruled in favor of a coalition that included several Christian organizations, and issued an injunction to block federal funding for stem cell research.

The appeals court ruled earlier this month that the government can keep funds flowing for the research during the initial stages of the administration?s challenge to the ban.

The judge who ordered the cutoff of federal funds cited a 1996 law, the Dickey-Wicker Amendment, that forbids using government money to produce stem cells from human embryos.

Northwestern Medicine participates in world's first human embryonic stem cell clinical trial for spinal cord injury

2010-09-23T14:01:00.000-07:00

THE MEDICAL NEWS
23. September 2010

Northwestern Medicine and RIC ready to enroll first subject in spinal cord injury study

Northwestern Medicine is the first site open for enrollment in a national clinical research trial of a human embryonic stem cell-based therapy for participants with a subacute thoracic spinal cord injury. Following the procedure, participants will receive rehabilitation treatment at The Rehabilitation Institute of Chicago (RIC).

Northwestern also is the lead site of the trial, sponsored by Geron Corporation (Nasdaq: GERN). The trial eventually will include up to six other sites and enroll up to 10 participants nationally.

"We are very pleased to be the first participating center in the world's first human embryonic stem cell clinical trial for spinal cord injury," said lead national investigator Richard Fessler, M.D., professor of neurological surgery at Northwestern University Feinberg School of Medicine and a surgeon at Northwestern Memorial Hospital.

"Injection of oligodendrocyte progenitor cells directly into the spinal cord lesion is a rational way to attempt to arrest or reverse the structural damage in the spinal cord caused by severe trauma," Fessler said. "We are eager to begin evaluating the effects of these cells in subjects with severe spinal cord injuries."

Continued on Next page >>

Umbilical cord stem cells for treating diseases

2010-09-23T13:41:00.000-07:00

Express News Service
First Published : 16 Sep 2010
express buzz

HYDERABAD: One has heard of diseases and ailments like cancer, heart problems, diabetes, neurological problems. But not all are aware that a possible solution for the disorders can be found in our body.

The blood stem cells from the umbilical cord of a newborn can be used for treatment of not only the baby but also his/her family members, in case they are affected with threatening diseases.

Cryo-Save, a leading stem cell bank held a press conference on Wednesday highlighting the importance of cord blood stem cell preservation and its usage. They also declared September as the Cord Blood Stem Cell Awareness Month.

Speaking to reporters, Parijatha Rao, director of laboratory operations, Cryo-Save India stressed the need for more public awareness on this subject, especially in pregnant women.

“Many people in the country are not aware of the use of the umbilical cord of a newborn baby. It can be used in the treatment of many incurable diseases like those related to the liver, brain, cancer and others. As of now, only 1500 mothers in a month, get the umbilical cord of their baby stored. We would like to encourage more expectant mothers to come forward in storing the umbilical cord of their child.”

Later, Mohana Vamsy, chief surgical oncologist at the Omega Hospital observed that since the umbilical cord is usually considered a medical waste and thrown away, there was no harm in storing it.

Cryo-Save presently charges Rs 75,000 to store the umbilical cord for a period of 21 years.

expresshyd@expressbuzz.com

Democrats, Republicans Spar Over Ethics of Embryonic Stem Cell Research

2010-09-23T13:37:00.000-07:00

FOXnews.com
Published September 16, 2010

Senate Democrats argued a moral imperative to allow federal funding of embryonic stem-cell research, in a hearing Thursday that comes a week after an appeals court temporarily lifted a judge's ban on federal funding of it.

"We have a moral responsibility" to pursue embryonic stem cell research, said Sen. Tom Harkin, D-Iowa, chairman of the Labor, Health and Human Services, Education, and Related Agencies Subcommittee, adding that the method is vital in combating an array of debilitating medical conditions.

Harkin referenced last week's decision by a U.S. Appeals court to temporarily lift a judge's ban on federal funding of the research until it rules on the merits of the Obama administration's argument against the ban.

He blasted a ruling last month by U.S. District Judge Royce Lamberth, who decided that embryonic stem cell research violated federal law because it involved destroying human embryos.

"Out of the blue," Harkin said, Lamberth "placed a cloud of uncertainty over this field. ...

"We've come too far to give up now," he said. "If we don't win this battle in the courts, will have to take it up in Congress."

Thursday's committee summoned a panel of top scientists and researchers, including National Institutes of Health director Francis Collins, to speak about the scientific promise of the field. He also warned of Lamberth's ruling.

Collins said that "this field has been thrust into a precarious state" and warned that "patients may have to keep hope on hold."

Collins argued before the subcommittee that embryonic stems cells are critical in fighting heart disease, diabetes, Parkinson's disease, vision problems and spinal cord injuries.

But Mississippi Republican Sen. Roger Wicker, who testified as a witness during the hearing, said the research using fetal tissue for stem cell research raises "profound moral and ethical challenges."

He argued profusely against using taxpayer money to fund it.

"This is a matter of conscience for me but more importantly it is a matter of conscience for millions of Americans," he said. "The question is whether the federal government should be subsidizing it."

Wicker proposed that scientists "reprogram" adult stem cells -- which have been widely successful in treating various medical conditions -- to "act like embryonic stem cells."

"Adult stem cells are the ones that are treating people now," Wicker said. "An estimated 50,000 adult stem cells transplants are occurring annually worldwide."

Venture Firms Look Beyond Embryonic Stem Cells

2010-09-23T13:33:00.000-07:00

The Wall Street Journal
Venture Capital Dispatch
September 20, 2010
By Brian Gormley

Federal funding for embryonic stem cells may be in doubt, but venture firms see several other ways to invest in regenerative medicine.

A U.S. appeals court earlier this month suspended the ban on federal funding for embryonic stem-cell research that resulted from an Aug. 23 U.S. district court ruling, which said use of federal taxpayer dollars for work that destroys human embryos violates a provision of a law first enacted in 1996.

But the extent that scientists can count on federal funding for these cells remains unclear, which is one reason most venture firms favor other approaches to regenerative medicine, such as adult stem cells or certain proteins. The uncertainty last month’s ruling created could lead them to prefer these alternatives even more.

“Venture guys are good at managing market risk,” said Gregory A. Bonfiglio, managing partner of Proteus Venture Partners. “Most don’t want to be in the business of managing political risk.”

The political risk became apparent in 2001, when President Bush restricted federal funding for embryonic stem cells to a group of existing cell lines. President Obama lifted those limitations last year, but recent events have spawned more doubt about whether scientists will be able secure federal money to study embryonic stem cells, which can give rise to all types of cells in the body.

Their flexibility, or pluripotency, gives them the potential to be used to develop a wide variety of therapeutic cells. Adult stem cells, or undifferentiated cells found in specialized tissue, can give rise to mature cell types in the tissue or organ in which they are found.

Funding restrictions for embryonic stem cells hurt companies selling research tools to academic scientists, who rely heavily on grants. One company feeling the impact is Stemgent Inc., whose products are used mostly to investigate pluripotent stem cells. Scientists want to be clear about funding sources before investing in products to support a project, according to Chief Executive Ian Ratcliffe.

But Stemgent also has technology targeting a newer field: induced pluripotent stem cells, or adult stem cells genetically reprogrammed to an embryonic stem cell-like state. Since these cells are not harvested from an embryo, they sidestep ethical concerns weighing on the embryonic stem-cell field.

The company, whose backers include HealthCare Ventures and Morgenthaler Ventures, is one of a few venture-funded businesses taking aim at this emerging market. Another is iPierian Inc., which uses induced pluripotent cells, or iPS cells, to discover drugs.

The process involves reprogramming adult cells from patients into a pluripotent state, then differentiating them into specific cell lineages that can be used in drug discovery. Kleiner Perkins Caufield & Byers is among its investors.

Also exploring the iPS field is ViaCyte Inc., one of the few venture-backed companies with a embryonic stem cell-based product nearing clinical trials. ViaCyte hopes to free diabetes patients from regular insulin shots through an implant, derived from embryonic stem cells, that secretes insulin.

In the future, iPS cells may enable ViaCyte – formerly Novocell Inc. – to develop a product without embryonic cells, said CEO John West. For now, however, that is a distant goal.

“We can make the whole product with embryonic stem cells and it could work well,” West said. “The performance we’ve achieved with iPS cells is nowhere close to what we’ve achieved with embryonic stem cells.”

Continue reading this story in VentureWire here.

Harkin will continue push for stem cell research

2010-09-19T18:40:00.001-07:00

By TIM ROHWER, Staff Writer, timothy.rohwer@nonpareilonline.com
Published: Friday, September 17, 2010
Nonpareil Online

Sen. Tom Harkin, D-Iowa, said Thursday he would keep pushing for continued human embryonic stem cell research because its future seems unclear.

During his weekly telephone news conference, Harkin expressed satisfaction with a decision by a District of Columbia judge to overturn a lower court’s ruling that called for a halt to such research. But the higher court’s decision’s is a temporary stay, Harkin said.

“How long that will last is anyone’s guess,” he said.

If the battle to continue this research isn’t done in the court, then Congress may take it up, he said.

“This research must continue,” he said. “The majority of the people want this to continue.”

On another topic, Harkin had mixed reviews on Tuesday’s Delaware Senate victory by Tea Party favorite Christine O’Donnell. On the one hand, her victory could help Democratic candidate Christopher Coons.

“I do believe it’s causing consternation in the Republican Party” Harkin said of the Tea Party movement.

On the other hand, he expressed disappointment on the defeat of moderate Republican Michael Castle.

“He was a bright, capable individual,” Harkin said.

“He was one of the more moderate members of the Republican Party. We need a more moderate section of the Republicans. I believe in a good two-party system, but they have to be broadly based. The more narrow the Republican get, the harder it will be to do business.”

Appeals court to hold hearing on stem cell ban

2010-09-16T15:06:00.001-07:00

WASHINGTON | Wed Sep 15

(Reuters) - An appeals court on Wednesday scheduled rare oral arguments for next week over whether to temporarily allow federal funding of human embryonic stem cell research.

The Obama administration has appealed a lower court ruling that barred federal funding of the research last month after determining that it was prohibited under U.S. law because human embryos were being destroyed.

The U.S. Court of Appeals for the District of Columbia Circuit put that injunction on hold briefly while it considers the emergency appeal by the administration. The court scheduled a 30-minute oral argument for September 24.

President Barack Obama allowed more federal funding for human embryonic stem cell research as one of his first acts after taking office in 2009 in hopes it would lead to cures for more diseases.

Two doctors, Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute, and Theresa Deisher, of Washington-based AVM Biotechnology, challenged the administration's guidelines that expanded the research.

They argued it violated U.S. law because human embryos were destroyed and it created unfair competition for limited money for their own work on adult stem cells. They both opposed human embryonic stem cell research.

The Obama administration has argued that the lower court ruling was at odds with the intent of Congress when it wrote the law limiting federal funding of human embryonic stem cell research and that it would undercut ongoing medical research.

(Reporting by Jeremy Pelofsky, editing by Cynthia Osterman)

Joan of Arc, and the Trial of Stem Cell Research

2010-09-14T17:31:00.000-07:00

The Huffington Post
Sept 14, 2010
By Don C. Reed - Sponsor, California’s Roman Reed Spinal Cord Injury Research Act of 1999

Like the case against embryonic stem cell research, the trial of Joan of Arc was political.

The armies of England occupied France: Joan led the fight to drive them out. When she was captured at last, the English knew it was not enough to kill her; she must be discredited as well.
The Church (which had taken the side of the occupiers) was willing to help. For weeks on end, Bishop Pierre Cauchon and his one hundred seventeen religious lawyers confronted the fifteen year-old girl, trying to make her confess to witchcraft.

They took her to the torturer, who demonstrated the cruel use of his tools. But Joan defied them, saying: "You can tear my body asunder... But if you make me speak falsely through pain, I will deny it later, as taken under duress."

They tried to shame the modest maid, asking if her angels appeared to her...naked. "Do you think God cannot afford to clothe his saints?" she answered.

Cauchon devised a wicked question, to trap the unlettered maid. "Are you, Joan, acting in the will of God?"

If she said yes, she was a witch and must die, because no one can know the will of God. If she said no, she was going against God--and was a witch and must die. Joan did not hesitate.

"If I am, may He keep me in the right. If I am not, may he show me the way."

"Magnificent answer," wrote the transcriber; Cauchon was furious. But it was for naught.

By the tawdriest of tricks, Joan was found guilty-- of the crime of wearing men's clothes. Her woman's dress was taken away while she slept, leaving her no choice what to put on in the morning.

She was burned to death; her ashes scattered in the Seine River.

Cauchon had done his job, "proving" her guilt; ironically, he made sure the transcripts of the trials were preserved, in hopes it would advance his career. Instead, Cauchon became a name for cruelty: the trial an abuse of religious power.

The case against federal funding of embryonic stem cell research is of that ilk.

Sherley v. Sebelius, is brought by religious ideologues, and it will be tried by members of a political party on record as intending to ban the research.

This is no secret. The 2008 Republican party platform calls for "a ban on all embryonic stem cell research, public or private."

The judge in charge, Reagan-appointee Royce C. Lamberth, is a transplanted Texas Republican. The three-judge panel that found a pretext to let the trial to go forward--three more Republicans, all appointed by George W. Bush or his father.

And if the trial is appealed to the Supreme Court, Justice Roberts' court, perhaps the most conservative in modern history? A majority of conservative Republicans wait there.

Why would Republicans want to ban embryonic stem cell research?

It is a stalking horse for the abortion issue, a gift to the Religious Right, part of their endless struggle to overturn Roe V. Wade, and end forever a woman's right to choose.

What does embryonic stem cell research have to do with abortion? Nothing. There is no pregnancy in the research. It is biologically impossible for an unemplanted blastocyst to become a baby. No mother's womb, no baby--this is not rocket science.

Calling embryonic stem cell research "murder of young humans" is like calling Joan of Arc a witch because she wore trousers on the battlefield.

Adult stem cell researchers James Sherley and Theresa Deisher are ideologues. Catholic Theresa Deisher named her biomedical company after the Virgin Mary (AVM for Ave Maria); Baptist James Sherley (famous for throwing a hunger strike and crying racism when his tenure at MIT was denied) is a vehement denouncer of women's reproductive freedoms, calling abortion a "social disease".

Their standing in the case? Deisher and Sherley are upset about having to compete for research money. They want federal dollars reserved exclusively for adult stem cell researchers like themselves, and claim "immediate and irreparable damage" from having to compete against embryonic stem cell research projects.

On that basis, their wish to change the rules to benefit themselves, the Republican appeals court granted them standing--and by so doing allowed the case against federal funding of embryonic stem cell research to go forward.

It would be laughable, if it were not so cruel.

The crux of the argument? An obscure law, the Dickey-Wicker (DW) Amendment, forbids the destruction or endangerment of embryos in federally-funded research.

Citing Dickey-Wicker as the "unambiguous intent of Congress", Judge Lamberth declares that federal dollars cannot be used for embryonic stem cell research.

But how can this obscure Act be called the "unambiguous intent of Congress"-- when it has never once been voted on (nor even debated) by Congress?

The Dickey-Wicker Amendment was shoved through, attached to un-related budgetary legislation. If Congress wanted the budget passed, they had to accept DW-- and that maneuver has worked ever since. No politician wants to be accused of "endangering" embryos, even donated blastocysts that were going to thrown away, and that would never be implanted in the womb.

And so the trick worked, and the Dickey-Wicker Amendment remained.

Why has it not been vigorously opposed before now?

In 1999, a funding approach was developed that was acceptable to three U.S. Presidents, (Clinton, G.W. Bush, and Obama) as well as Congress.

The Department of Health and Human Services allowed the federal government to fund research with human embryonic stem cell lines, provided that:

1. the lines were derived with funding from non-federal sources;
2. the stem cells were made from blastocysts made during in vitro fertilization (IVF) procedures, and were no longer needed for medically assisted reproductive purposes, and which would otherwise be thrown away;
3. and which were donated (without compensation) for medical research.

Under these careful terms--restricted still further by President Bush--the research went forward.

"Unambiguous"? Judge Lamberth has it backward. Congress was unambiguously in support of federal funding for human embryonic stem cell (hESC) research.

Unlike the stealth approach used to impose Dickey-Wicker, Congress had a full and vigorous debate on federal funding for hESC research: and approved it-- twice.

The Stem Cell Research Enhancement Acts of 2005 and 2007 passed both houses with strong majorities. President Bush vetoed both bills, but the will of Congress was clear.

If Sherley v. Sebelius prevails, the will of Congress will be denied, not upheld.

Joan of Arc did not live to see her great victory. But her courage and faith inspired France, and they rose and drove the English out.

Twenty years after her execution, Joan's mother, Isabel Romme, sued the Church, saying her daughter was not a witch.

To its everlasting credit, the Church admitted its error, declaring the trial null and void.

The new verdict, of course, came too late to help the beloved Maid of Orleans.

But there are other young people whose lives we can benefit.

One is Kaitlin (last name withheld). I have never met her. But here is what I do know:

"On her first day in the hospital (with type one diabetes--DR) 2-year-old Kaitlyn looked up at her father from her bed, intravenous tubes in both her arms, her hair matted, and said, "Daddy?"

"What, honey?" he said, bending over the railing of the bed.

"Fix," she said."
--Newsday, May 23, 2004

America needs stem cell research protection written into law, and we need it now.

Congress must do again what they did twice before, and approve the Stem Cell Research Enhancement Act, suitably vetted to be sure it overrides Dickey-Wicker.

To accomplish that goal, Senator Arlen Specter has just introduced the "Stem Cell Research Enhancement Act of 2010."

It deserves immediate passage and the complete support of the advocate community.

This time we have a President who will sign it.

Follow Don C. Reed on Twitter: www.twitter.com/diverdonreed

Bill Proposed To Safeguard Govt Funding For Stem Cell Research

2010-09-14T17:28:00.001-07:00

Posted on: Tuesday, 14 September 2010
redOrbit

On Monday, a U.S. senator unveiled a bill to help safeguard government funding for human embryonic stem cell research.

Democratic Senator Arlen Specter said that his proposal would help "codify in law President Barack Obama's March 2009 executive order lifting restrictions predecessor George W. Bush had imposed on such research," according to the AFP news agency

Specter pointed to a federal judge's temporary injunction in August that freezes federal funds for human embryonic stem cell research, which a U.S. appeals court later lifted in a victory for backers of the pioneering scientific work.

"Even a temporary suspension of funding will disrupt the work on these important research projects in the areas of heart disease, sickle cell anemia, liver failure, muscular dystrophy and other maladies," the senator, himself a cancer survivor, told AFP news.

U.S. district court judge Royce Lamberth found that the researcher violated a 1996 law that forbids using government money to produce stem cells from human embryos.

The decision was seen as a victory amongst several Christian organizations that views fertilized human eggs as people entitled to the right of life.

Although stem cell research is vastly popular amongst the U.S. public, it remained unclear whether the U.S. Congress would approve legislation like Specter's before November's legislative elections.

Researchers say that stem cells provide two promising avenues for scientists. One of which they say could be used for research that cannot be performed inside the body. However, scientists believe they can also coax the foundation cells into cardiac, pancreatic or brain cells in order to replace damaged cells and allow tissue or organs to constitute themselves.

The senator said that the U.S. National Institute of Health reported that $546 million has been spent on human embryonic stem cell research "and phenomenal progress has already been made in realizing the possible benefits."

Spector's bill requires that stem cells be derived from human embryos created for reproduction purposes and donated by in vitro fertilization clinics because they would never be implanted.

The bill also calls for written consent from individuals who donated the embryos, and would forbid the use of federal funds to derive stem cell lines.

Obama acknowledged in a "town hall" meeting in Virginia the "legitimate ethical issues" in the research, but renewed his commitment to make decisions based on "sound science."

He said that his administration was "appealing" and "challenging" Lamberth's ruling, while working to "try to build a common sense consensus that allows us to make progress over the long term."

---

On the Net:

Statement: Specter to Introduce Stem Cell Research Advancement Act

Source: RedOrbit Staff & Wire Reports

What Is The State Of Stem Cell Research Today?

2010-09-14T17:24:00.000-07:00

Editor's Choice
Main Category: Stem Cell Research
Also Included In: Biology / Biochemistry
Article Date: 13 Sep 2010
MEDICAL NEWS TODAY

As most are aware, stem cell research has been an ongoing topic of much controversy and debate for years. So what the latest update and general global concensus these days? Will we actually be able to use stem cells and apply the potential this technology holds to treat heart disease, nerve disorders, intestinal disabilities, pulmonary disease, diabetes and much more? In this month's special edition of Translational Research, the latest developments are discussed and debated from both sides of the controversy by an international team of experts.

Dr. Jeffrey Laurence, M.D., Professor of Medicine at Weill Cornell Medical College and Editor in Chief of Translational Research summarizes:

Publication of this special issue could not have been more timely, given the recent federal district court injunction against federal support for human embryonic stem cell research, this court order stops all pending federal grants and contracts, as well as their peer review, suspending over 20 major research programs and over $50 million in federal funding for them.

Stem cell research began with a goal of being able to cure persons based on their own unique genetic make-up and healing inefficiencies by using harvested cells. There are enormous scientific challenges, but the most debated points of discussion, government intervention and personal doubt, come from intense ethical inclusions such as privacy, consent and at times the withdrawal of that consent to use embryos for example in this evolving treatment application.

Addressing the federal court injunction, Dr. Francis Collins, NIH (National Institute of Health) director, states:

This decision has the potential to do serious damage to one of the most promising areas of biomedical research, just at the time when we were really gaining momentum.

There is a tremendous amount of preclinical testing that still needs to be done however despite court ordered pauses in research. Potential treatments utilizing a variety of therapeutic options are potentially available, and seem to all be very promising. There is evidence supporting the potential therapeutic use of stem cells for acute and chronic diseases. However, the adaptation of preclinical work to in-practice clinical application is a key challenge to the work as the results of several randomized clinical trials indicate. Authors of this latest report all agree that considerable preclinical work is needed to test the potential of these approaches for translation to the clinical setting.

Michael A. Matthay, MD, Cardiovascular Research Institute, University of California San Francisco, said:

The progress that has been achieved in the last 30 years in using allogeneic and autologous hematopoietic stem cells for the effective treatment of hematologic malignancies should serve as a model of how clinical applications may yet be achieved with embryonic stem cells, induced pluripotent stem cells, endothelial progenitor cells, and mesenchymal stem cells. Although several challenges exist in translating stem cell therapy to provide effective new treatments for acute and chronic human diseases, the potential for developing effective new cell-based therapies is high.

As has always and will continue to be the case, key questions and challenges remain. For example, The Translational Research article focuses on if use of any stem cell population will increase the risk of cancer in a patient. Also there is inquiry into what is the true long term goal of this research. Is it to deliver therapy is to deliver cells that can function as organ-specific cells for example. Keeping a close eye on the medical and governmental progress on this topic is the key to truly understanding the totality of one of the most debated and grand medical evolutions of our time.

"Bone marrow and circulating stem/progenitor cells for regenerative cardiovascular therapy"

Mohamad Amer Alaiti, Masakazu Ishikawa, and Marco A. Costa

"New therapies for the failing heart: trans-genes versus trans-cells"

Vincenzo Lionetti, and Fabio A. Recchia

"Endothelial lineage cell as a vehicle for systemic delivery of cancer gene therapy"

Arkadiusz Z. Dudek

"Pluripotent stem cell-derived natural killer cells for cancer therapy"

David A. Knorr, and Dan S. Kaufman

All these articles appear in the journal Translational Research.

Written by: Sy Kraft, B.A. - Journalism - California State University, Northridge (CSUN)
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Congress registers its support for human embryonic stem-cell research

2010-09-13T17:43:00.001-07:00

September 13, 2010
The Los Angeles Times

As the National Institutes of Health fights in court for permission to resume long-term funding for research involving human embryonic stem cells, some members of Congress are coming to the agency’s defense with a proposal to make President Obama’s stem-cell funding policy the law of the land.

Monday in Washington, D.C., Sen. Arlen Specter (D-Penn.) spoke in favor of the Stem Cell Research Advancement Act. This bill would make clear Congress' intent to allow federal funds to be used on the promising research, which is controversial because the cells themselves are derived from days-old human embryos, which are destroyed in the process.

The bill has passed Congress twice – in 2005 and in 2007 – but was vetoed both times by President Bush. It was re-introduced in February 2009, but action on it stalled after Obama expanded stem-cell funding through an executive order.

Here’s some of what Specter had to say:

“More than 400,000 embryos are stored in fertility clinics around the country. If these frozen embryos were going to be used for in vitro fertilization, I would be the first to support it. In fact, I have included funding in the HHS budget each year since 2002 to create and continue an embryo adoption awareness campaign. For fiscal year 2010, this campaign is funded at $4.2 million. But the truth is that most of these embryos will be discarded, while they hold the key to curing and treating diseases that cause suffering for millions of people.”

This is the reasoning behind Obama’s stem-cell policy – why let those excess embryos go to waste? But last month, U.S. District Court Judge Royce Lamberth disagreed. In a ruling issued as part of a lawsuit that seeks to end Obama’s policy, the judge said that the Dickey-Wicker amendment forbids the federal government from paying for research in which human embryos are harmed or destroyed, including stem-cell research. An appeals court temporarily blocked Lamberth's ruling last week.

But in his statement, Specter emphasizes that Congress did not intend for the Dickey-Wicker amendment to preclude funding for human embryonic stem-cell research. Everyone agrees that the law prevents the federal government from paying scientists to create the stem cells. But once created, the cells themselves are supposed to be eligible for NIH funding, Specter says.

As proof of Congress’s intent, he cites his own floor statement from 1999:

“In that statement, I explained that the budget for NIH maintained the Dickey-Wicker amendment by permitting research to go forward now with private funding extracting the stem cells from embryos, and then the federal funding coming in on the stem cells which have been extracted.”

That squares with the legal analysis conducted by the Department of Health and Human Services, which runs the NIH. It’s 1999 legal opinion states that:

“Pluripotent stem cells [including human embryonic stem cells] are not organisms and do not have the capacity to develop into an organism that could perform all the life functions of a human being. They are, rather, human cells that have the potential to evolve into different types of cells such as blood cells or insulin-producing cells. Pluripotent stem cells do not have the capacity to develop into a human being, even if transferred to a uterus. Based on an analysis of the relevant law and scientific facts, federally funded research that utilizes human pluripotent stem cells would not be prohibited by the HHS appropriations law prohibiting human embryo research, because such stem cells are not human embryos.”

Meanwhile, Sen. Tom Harkin (D-Iowa), who re-introduced the Stem Cell Research Advancement Act last year, is planning to hold a hearing this Thursday titled “The Promise of Human Embryonic Stem Cell Research." Among those scheduled to testify are NIH Director Francis Collins and researchers Sean Morrison, director of the Center for Stem Cell Biology at the University of Michigan, and Dr. George Daley, director of the Stem Cell Transplantation Program at Children’s Hospital Boston.

The hearing begins at 10 a.m. EDT and will be webcast at http://appropriations.senate.gov/.

-- Karen Kaplan/Los Angeles Times
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