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Biomedicine

New Court Ruling Could Cripple Stem-Cell Research

Once again, federal funding restrictions cast uncertainty over the field.

It was just 18 months ago that U.S. scientists studying embryonic stem cells thought their nearly decade-long battle for federal funding was finally won. President Obama had signed an executive order ending a restrictive policy enacted in 2001 by President Bush. That policy had blocked federal funds from being used to study most human embryonic stem cells. But a surprise ruling by a lower court last week left the stem-cell community stunned. A federal judge issued an injunction, blocking federal funding for any research involving embryonic stem cells.

Researchers say the decision–even if it is later reversed–will have a damaging effect on the field, stunting promising medical research that was just building momentum. All grants under review at the nation’s largest funding agency, the National Institutes of Health (NIH), that involve human embryonic stem cells have been put on hold while the NIH and other government agencies try to get the injunction reversed.

“Without federal grant dollars, the science will slow to a crawl, again,” says George Daley, director of the Stem Cell Transplantation Program at Children’s Hospital Boston. “We have seen an enormous outpouring of interest over the last year, with between 200 to 300 grants approved for use of embryonic stem cells. Every one of those grants and labs is now enjoined from using federal dollars. They will either have to stop doing work altogether or try to cobble together private funds, which are in short supply in this economy.”

At the heart of scientists’ disappointment is the delay the ruling will create in developing new therapies. “Patients have been waiting nearly 10 years to use the power of American science to unleash new treatments for disease,” says Doug Melton, codirector of the Harvard Stem Cell Institute. “I have heard from many who are deeply disappointed, howling, ‘How could this happen?’ “

Embryonic stem cells, first derived from human embryos in 1998, have captured intense interest from both scientists and the general public for their ability to develop into any cell type in the body. Researchers ultimately aim to generate replacement tissue for cells lost or damaged to disease or injury. In the nearer term, scientists are using them to study the molecular mechanisms of disease, as well as to screen experimental drugs.

However, the cells have also been the subject of controversy; the lines of embryonic stem cells that scientists use are generated from excess embryos donated from fertility clinics. While these embryos would have ultimately been discarded, opponents object to any research that requires the destruction of human embryos. In 2001, President Bush struck a compromise, permitting researchers to use federal funds to study only a limited set of embryonic stem-cell lines already in existence. Those who wanted to create new lines or study them had to garner state or private money, in some cases setting up duplicate labs to carry out federally funded and privately funded projects.

Obama’s executive order last year lifted the restrictions on federal funding. But a largely under-the-radar lawsuit brought by two scientists studying adult stem cells has made things even worse than the earlier Bush policy. Judge Royce Lamberth of the Federal District Court for the District of Columbia prohibited all embryonic stem-cell research from receiving federal funding.

“I’ve been working with embryonic stem cells for nine years and seen the waves come and go,” says Sean Palecek, a stem-cell researcher at the University of Wisconsin, Madison. “Right now is the most restrictive that it’s ever been.” Palecek and others worry that this latest blow will discourage young scientists from entering the field. “It’s really disheartening,” he says. “It’s hard enough to come up with cutting-edge ideas and to get funding. The possibility of having funding pulled at any time sends the wrong message.”

In the aftermath of the ruling, the NIH said that work under existing grants can go on, though it has stopped reviews of new grants or existing grants up for renewal. (A different interpretation of the injunction by the U.S. Department of Justice could halt ongoing research as well.) According to the NIH, 22 grants, worth $54 million, were up for renewal during September. A dozen other grants, worth $15 to $20 million, had scored highly in the first round of reviews and were likely to be funded. Those have now also been put on hold, as have about 50 new grant applications involving embryonic stem cells.

Palecek is one of hundreds of scientists likely to feel the effects. His lab is developing ways to create heart tissue from embryonic stem cells, with the ultimate goal of understanding heart disease better and testing new treatments. He has one grant up for renewal, and a second new grant that was likely to be funded. Both will now be put on hold. If the injunction lasts long enough, he’ll likely lose personnel.

Mortimer Poncz, a physician and scientist at the University of Pennsylvania who is developing new treatments for blood disorders, had received high scores for a grant to fund a stem-cell facility at his institution. The facility, which would provide expertise for scientists new to the field, has also been put on hold. That scenario may play out at universities across the country. Many universities had begun building or expanding stem-cell research programs in the last year.

Part of the increased interest in stem cells in recent years comes from the development of so-called induced pluripotent stem (iPS) cells, which are derived from adult tissue but mimic embryonic stem cells’ ability to differentiate into any type of tissue. However, scientists say this new cell type does not eliminate the need for embryonic stem cells. On the contrary, it’s not yet clear whether iPS cells possess all the properties of embryonic stem cells. And because so much more is known about the embryonic stem cells, scientists frequently use them in iPS cell experiments as a comparison.

Lawrence Goldstein, a scientist at the University of California, San Diego, is using embryonic stem cells to test new treatments for a fatal and untreatable childhood disorder. “The families really want us to make progress as rapidly as possible,” says Goldstein. “Now we may have to generate a new set of technology. What do I tell the parents of these kids?”

No one knows how long the situation will last. The Obama administration says it will appeal the ruling, and the Justice Department says it will ask for the injunction to be lifted, pending appeal.

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