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NIH May Ease Some, But Not All, Stem Cell Restrictions

Agency says cells should come from fertility clinic embryos that otherwise would be discarded

FRIDAY, April 17 (HealthDay News) -- Scientists hoping to use U.S. funding for embryonic stem cell research must use cells from fertility clinic embryos that otherwise would be discarded, the National Institutes of Health announced Friday.

The proposed guidelines exclude more controversial research -- such as using stem cells taken from embryos created for science -- in favor of a limit with broad congressional support, the Associated Press reported.

The public will have one month to comment on the guidelines before the NIH issues final rules by early July, the news service said.

"We think this will be a huge boost for the science," said Acting NIH Director Raynard Kington. "This was the right policy for the agency at this point in time."

But some researchers will be disappointed with Friday's announcement, hoping they would gain wider access to a broader variety of cells, the AP said.

The new guidelines also require that the woman or couple who donate the original embryo give proper informed consent, without pressure from scientists. And the guidelines forbid some types of research using human embryonic stem cells -- such as mixing them with embryos from monkeys and other primates, the AP said.

Dr. R. Dale McClure, president of the American Society for Reproductive Medicine, said his group was "pleased" with the proposed new rules.

"Federally funded scientists will soon be able to put forward research proposals to help us unlock the full potential of human embryonic stem cells," McClure said in a statement. "That work may eventually yield treatments for some of our most stubborn ailments; it may lead to a new set of research tools, but whatever direction the research points to, we are now closer to answers."

But another expert was more sparing in her praise.

"These are draft guidelines and only a first step," Susan L. Solomon, CEO of the New York Stem Cell Foundation, noted in a statement. "We are disappointed that the NIH proposes to fund only those embryos leftover from IVF treatments, denying funding for lines specifically created for research purposes. The proposed guidelines limit some very promising avenues of current research and limit the genetic diversity of the stem cell lines that will be eligible for federal funding."

Last month President Barack Obama signed an executive order that he said would allow federal taxpayer dollars to fund significantly broader research on embryonic stem cells because "medical miracles do not happen simply by accident." He said his administration would make up for what he called the ground lost under his predecessor, President George W. Bush, who's 2001 directive prohibited the use of federal funds for research using embryonic stem cell lines created after that date.

Embryonic stem cells are the most basic human cells, believed to be capable of growing into any type of cell in the body. Working as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells. The scientific hope is that stem cells may, at some point in the future, become capable of treating a variety of diseases and conditions, such as Parkinson's disease, diabetes, heart disease and spinal cord injuries, according to the NIH.

When Obama revealed his plans last month to develop new guidelines for stem cell research, scientists applauded the move.

"This action is both welcome and overdue," Dr. Philip Pizzo, dean of the Stanford School of Medicine and a governing board member of the California Institute of Regenerative Medicine, said in the statement. "This vote of confidence from President Obama in the promise of embryonic stem cell research validates and extends CIRM's mission to help millions of people suffering from currently incurable medical conditions. It is also a powerful signal that advances in medical research must be pursued even in times of economic difficulty."

Dr. Joseph Heyman, board chairman of the American Medical Association, said: "The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research. "

Stem cell research received a big boost in January, when the U.S. Food and Drug Administration approved the first-ever human trial using embryonic stem cells as a medical treatment. Geron Corp., a California-based biotech company, was given the OK to implant embryonic stem cells in eight to 10 paraplegic patients who can use their arms but can't walk.

In 2001, then-President Bush limited federal funding for stem cell research only to human embryonic stem cell lines that already existed. The decision prompted some scientists to worry that the United States would fall behind other countries in the drive to unlock the potential of stem cell research.

National polls continue to find that the majority of Americans favor embryonic stem cell research, although some surveys have found that that support has declined somewhat in recent years.

Many people object to the use of embryonic stem cells, contending that the research requires the destruction of potential life, because the cells must be extracted from human embryos.

Since the restrictions on embryonic stem cell research took effect in 2001, many research institutions have redirected their focus to other types of stem cells, such as adult stem cells.

Adult stem cells can give rise to all the specialized types of cells found in tissue from which they originated, such as skin. But, scientists don't agree on whether adult stem cells may yield cell types other than those of the tissue from which they originate, according to the NIH.

More information

To learn more about stem cells, visit the U.S. National Institutes of Health.

SOURCES: Associated Press; April 17, 2009, statements, American Society for Reproductive Medicine, and New York Stem Cell Foundation; March 6, 2009, statement, Philip Pizzo, M.D., dean, Stanford School of Medicine, California; March 9, 2009, news release, American Medical Association, Chicago

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