Stem cells trial approve in US

[Hemanshu]

US approves first stem cell study for spinal surgery
23 Jan 2009, 1134 hrs IST, AP

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NEW YORK: A US biotech company says it plans to start this summer the world's first study of a treatment based on human embryonic stem cells - a
long-awaited project aimed at spinal cord injury.

The company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells, said Dr Thomas Okarma, president and CEO of Geron Corp of Menlo Park, Calif.

The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury.

“The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs,” Okarma said.

Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the US - a field where debate spilled out of the laboratory long ago and into national politics.

While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells.

``It's a milestone and it's a breakthrough for the field'' because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell Inc. His company hopes to begin a similar human study for treating diabetes in a few years.

In addition, said spinal cord injury researcher Dr Wise Young of Rutgers University, ``a lot of hope of the spinal cord injury community is riding on this trial.''

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.

President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the U.S. Food and Drug Administration's granting permission for the new study, Okarma said.

In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.

Other human cells, called adult stem cells, have been tested before in people to treat heart problems, for example.

“In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country,” Okarma said.

Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.

Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Okarma said. The idea is ``not to make somebody ... get up and dance the next day,'' he said, but rather to provide some level of ability that can be improved by physical therapy.

“Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn't be needed,” Okarma said. The study will follow each patient for at least a year.

Okarma said he can't estimate how much such a therapy would cost if it proves effective, but that ``this is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides.''

Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, Calif., said scientists in the field will focus chiefly on the study's results about safety.

``The one hope that everybody has is that nothing bad happens,'' he said.

Geron Corp. has spent at least $100 million on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.

However, the company is considered the world's leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.

[Vik]

yeah.. Stem cell research is back in US!

[Narendra]

News Update on Stem Cells... From:- Obama overturns Bush policy on stem cells - CNN.com

Hope for a cure of Thalassemia is back with this news

Obama overturns Bush policy on stem cells

WASHINGTON (CNN) -- President Obama signed an executive order Monday repealing a Bush-era policy that limited federal tax dollars for embryonic stem cell research.

Obama's move overturns an order signed by President Bush in 2001 that barred the National Institutes of Health from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.
Obama also signed a presidential memorandum establishing greater independence for federal science policies and programs.

"In recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values," Obama said at the White House.

"In this case, I believe the two are not inconsistent. As a person of faith, I believe we are called to care for each other and work to ease human suffering. I believe we have been given the capacity and will to pursue this research -- and the humanity and conscience to do so responsibly."

The president pledged to develop "strict guidelines" to ensure that such research "never opens the door to the use of cloning for human reproduction."

Such a possibility, he maintained, is "dangerous, profoundly wrong and has no place in our society or any society."

Obama's order directs the NIH to develop revised guidelines on federal funding for embryonic stem cell research within 120 days, according to Dr. Harold Varmus, president of Memorial Sloan-Kettering Cancer Center and co-chairman of Obama's science advisory council.

"The president is, in effect, allowing federal funding of human embryonic stem cell research to the extent that it's permitted by law -- that is, work with stem cells themselves, not the derivation of stem cells," Varmus said in a conference call with reporters Sunday.

While conceding that "the full promise of stem cell research remains unknown" and "should not be overstated," Obama nevertheless expressed hope that the order will help spur faster progress in the search for cures to afflictions such as Parkinson's disease, cancer and spinal cord injuries.

Researchers highly value embryonic stem cells because of their potential to turn into any organ or tissue cell in the body. Stem cells have this ability for a short time. A few days before the embryo would implant in the uterus, it starts to develop into specific cells that will turn into skin or eyes or other parts of a developing fetus.

When the embryo is 4 or 5 days old, scientists extract the stem cells and put them in a petri dish. With the removal of these stem cells -- of which there may be about 30 -- the embryo is destroyed.

Twenty-one of the 60 stem cell lines authorized for research under the Bush policy have proven useful to researchers. Bush twice vetoed legislation -- in July 2006 and June 2007 -- that would have expanded federally funded embryonic stem cell research.

At the time, Bush maintained that scientific advances allowed researchers to conduct groundbreaking research without destroying human embryos.
Conservative leaders echoed Bush's rationale in their criticism of Obama's decision.

"Advancements in science and research have moved faster than the debates among politicians in Washington, D.C., and breakthroughs announced in recent years confirm the full potential of stem cell research can be realized without the destruction of living human embryos," House Minority Leader John Boehner, R-Ohio, said Sunday.
Sen. Richard Shelby, R-Alabama, said the Bush policy imposed proper ethical limits on science.

"My basic tenet here is I don't think we should create life to enhance life and to do research and so forth," Shelby said Sunday. "I know that people argue there are other ways. I think we should continue our biomedical research everywhere we can, but we should have some ethics about it."

The issue of whether to lift the ban on federal funding for embryonic stem cell research has, however, exposed a clear rift between the more moderate and conservative factions of the GOP.

In February, a group of six moderate GOP congressmen sent a letter to Obama urging him to lift the funding ban.

Former first lady Nancy Reagan also issued a statement Monday thanking Obama for lifting the ban.

"These new rules will now make it possible for scientists to move forward," Reagan said. "Countless people, suffering from many different diseases, stand to benefit from the answers stem cell research can provide. We owe it to ourselves and to our children to do everything in our power to find cures for these diseases."

President Reagan was diagnosed with Alzheimer's disease after leaving office -- an affliction that many scientists say eventually may be cured with the help of embryonic stem cell research.

Obama's presidential memorandum, however, may turn out to have a broader impact than his executive order.

The memorandum is expected to create a clear change of tone from the Bush administration on a broad range of scientific issues.

Bush's critics argued the former president allowed political factors improperly to influence funding decisions for science initiatives as well as to skew official government findings on issues such as global warming.

Obama's memorandum directs the White House Office of Science and Technology Policy "to develop a strategy for restoring scientific integrity to government decision making."

In a thinly veiled criticism of his predecessor, Obama reiterated a promise to base "public policies on the soundest science" as well as to "appoint scientific advisers based on their credentials and experience, not their politics or ideology."

[Neel_R]

This is good news. Go Obama! Go Stem Cells!