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A New Federal Policy — What It Means for Stem Cell Research

STUMP, ELIZABETH

doi: 10.1097/01.NT.0000350658.09370.0c
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Leading investigators discuss the impact that a federal policy reversal on funding for stem cell research will have on the field.

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Will the reversal of an eight-year-old ban on federal funding for embryonic stem cell research usher in a new era for stem cell research? Experts in the field talked to Neurology Today about their expectations in response to a March 9 executive order by President Obama that overturned former President Bush's own executive order, which had limited federal funding for embryonic stem cell research to the stem cell lines already in existence in August 2001.

President Obama's action means that NIH-supported investigators can work with the hundreds of new lines created with private funding since 2001, as well as lines created in the future, explained John A. Kessler, MD, Boshes Professor of Neurology, chairman of the department of neurology, and director of the Feinberg Neuroscience Institute at Northwestern University.

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But researchers still don't have the freedom to entirely realize stem cell potential using NIH funds, explained Evan Y. Snyder, MD, PhD, professor and director of the Stem Cells and Regenerative Medicine program at the Burnham Institute for Medical Research in La Jolla, CA.

Federal researchers are still unable to create their own embryonic stem cell lines because of the Dickey-Wicker amendment, which prohibits researchers from using taxpayer money (NIH funding) to create human embryos for research or destroy them for their stem cells. (Embryonic stem cells can only be created using non-federal funds.) Since only Congress has the power to overturn the Dickey-Wicker ban, experts said they expect the policy-makers may soon move to pass legislation that addresses the quandary.

Congress may also move quickly on legislation to codify Obama's executive order in federal law, which would mean that future presidents could not alter it by executive order, said Arnold Kriegstein, MD, PhD, John G. Bowes Distinguished Professor in Stem Cell and Tissue Biology and the director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California-San Francisco.

Researchers are eager to create new lines of embryonic stem cells — considered the “gold standard” — because as undifferentiated cells they have the ability to develop into any type of cell in the human body, Dr. Kriegstein explained. Embryonic stem cell lines made after 2001 are in many ways improved compared to those made prior to 2001, with greater potential to develop into cell types, he said.

“There is now an unprecedented opportunity to explore the full potential of all forms of stem cell research,” said Dr. Kriegstein. One of the great benefits of the change in policy is the research advances that will now be possible by studying all types of stem cell lines, he said.

Particularly important is research into the basic science underlying stem cells, Dr. Synder said, which his lab will be doing. This will then allow them to understand how cancers arise and how human development goes wrong.

There is also great potential for induced pluripotent cells (derived from adult skin cells), and Dr. Kessler said that careful comparison of these cells to human embryonic stem cells is warranted.

However, despite the new federal policy, it will take months before stem cell researchers get their hands on any federal funding. “I doubt that this will signal an opening of floodgates of federal spending for embryonic stem cell research,” said Dr. Kriegstein. “The NIH has had a flat budget and there are many other worthy demands on those dollars.”

But Dr. Snyder said the announcement is welcome, especially during the current financial downturn, because private funding has been drying up. Yet “private funding is needed now more than ever,” Dr. Kriegstein said. “Private sources of funding can do what NIH funding cannot or will not do such as providing start-up packages for new faculty, funding pilot projects, as well as establishing cores, lecture series, and training programs. Private philanthropy, foundation funds, and support from the California Institute for Regenerative Medicine [the state agency that provides grants for stem cell research] are needed to leverage NIH dollars and accelerate discovery.”

The NIH has 120 days from the time of Obama's executive order to establish expanded research guidelines, including which newer lines will be considered suitable for research, how to disburse federal money, ethical standards for the derivation of lines, and regulations for donors (mandatory informed consent; no payment for egg or embryo donations). “Some lines may be excluded, for example, if it cannot be documented that they were derived with appropriate informed consent and without payment or undue influence,” said Dr. Kriegstein.

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ETHICAL GUIDELINES TO COME

Congress, however, should not become involved in creating ethical guidelines for the field, agreed Drs. Kessler, Snyder, and Kriegstein. “The NIH and its sponsored Institutions have extensive and well-considered ethical guidelines,” said Dr. Kessler, so “there is no need for Congress to pass such legislation.”

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“Most institutions have struggled to adapt their own ethical guidelines or adapted those issued by the National Academy of Science or the International Society of Stem Cell Research,” Dr. Kriegstein concurred. “Our stem cell research ethics committee has spent a great deal of time constructing a detailed, thoughtful approach to this issue. The NIH has been absent in this discussion because they have not funded the creation of human embryonic stem cell lines.”

“The past eight years have seen stunning scientific advances in stem cell research, but this has occurred against a backdrop of shrinking NIH support and policies that slowed the research and placed ideology above science,” Dr. Kriegstein said. “The changes we are witnessing today bring the policies in line with the science and will speed discovery and energize the field. It will create an environment that encourages, rather than discourages, young scientists, and will melt the ‘chill’ of the last eight years.”

©2009 American Academy of Neurology