NIH lifts main stem cell funding restriction

Washington -- New, less-restrictive regulations have opened the door to millions of dollars in federal funding for a wider range of human embryonic stem cell research.

The National Institutes of Health on July 6 unveiled final rules allowing research on stem cells derived from embryos specifically donated for that purpose by fertility clinic patients. Funding also will be available for research on privately created stem cell lines that meet the NIH ethical donation guidelines. President Bush's August 2001 executive order had banned federal funding for human embryonic stem cell research on all but the approximately 20 viable cell lines that had already been derived.

The new NIH regulations still carry some restrictions. For instance, they continue to prohibit federal funding for research on stem cells derived from cloned embryos. The rules took effect July 7.

Scientists and other experts said that even with the restrictions, the NIH rules are a significant step forward. Investigators have been relying on state and private funding. Allowing federal funding for work on existing lines is crucial to preserving the last several years of research, said Mark O. Lively, PhD, president of the Federation of American Societies for Experimental Biology.

Fertility clinic patients have been eager to have the freedom to donate embryos they no longer need as a way to advance research, said R. Dale McClure, MD, the American Society for Reproductive Medicine's president.

The society's spokesman, Sean B. Tipton, said he didn't think the NIH's written, informed consent requirements would discourage embryo donations or burden fertility clinics. "It's such an improvement over what federal policy had been," he said.

Patient advocates also expressed relief. "This will allow research that has been stifled for years to move forward," said Amy Comstock Rick. She is president of the Coalition for the Advancement of Medical Research, a group of more than 100 patient advocacy organizations.

Although NIH is receiving about $8 billion in stimulus funding for research grants, Lively expected most of that money to go toward unfunded grant requests received by NIH in 2008. NIH spokesman Don Ralbovsky could not say how much stimulus funding would go toward stem cell research.

Disappointment on both sides

Embryonic stem cell research remains deeply controversial. NIH received more than 49,000 comments in response to the draft rules issued April 23, but it rejected about 30,000 of them because they addressed whether -- not how -- such research should be conducted, Ralbovsky said.

NIH could have permitted funding for embryos made specifically for research, but it chose not to take that step. "I'm sure that disappointed some scientists," said Tom Murray, president and CEO of the Hastings Center, an independent bioethics research institute.

One disappointed scientist is Irving L. Weissman, MD, PhD, who directs Stanford University's Institute of Stem Cell Biology and Regenerative Medicine. He sees potential in deriving stem cell lines by transferring genetic material from a patient's regular cells to an egg cell, a process known as somatic cell nuclear transfer or therapeutic cloning. "Instead, their only justification for not funding research on these lines was that SCNT didn't have public support."

Still, FASEB spokeswoman Carrie Wolinetz, PhD, said she wasn't aware of any stem cell lines that had been produced using alternative methods such as SCNT.

Lively said the final stem cell rule shows how carefully NIH considered the issue. "The conservative approach they are taking is just indicative of the fact that they want to get it right."

Others decried the change. For the first time in the nation's history, human embryos will be destroyed in the course of NIH-funded projects, said William Hurlbut, MD, a consulting professor of neuroscience at Stanford University and a former member of President George W. Bush's Council on Bioethics. "It's a radical step to do what is being done."

Dr. Hurlbut expects the Obama administration to propose further expansions of stem cell research. "This is not over. ... This is the first chapter in a long story."

The NIH stem cell funding guidelines are available online (link).