NIH Announces Plan to Implement President's Stem Cell Executive Order

The National Institutes of Health (NIH) has announced that it will begin implementing President Bush's Executive Order to explore methods to expand the number of approved pluripotent stem cell lines "without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus."

The Executive Order calls on Health and Human Services (HHS) Secretary Michael Leavitt, who in turn is directing NIH, to conduct and support research that takes advantage of emerging potential alternative methods for generating stem cells that are pluripotent, i.e., capable of producing all or almost all of the cell types in the developing body.

"The NIH has developed a sound, ambitious strategy to advance pluripotent stem cell research and generate more opportunities in this critical area," Secretary Leavitt said. "I sincerely hope that these steps will accelerate the discovery of new cures and treatments."

"NIH has been pursuing the potential of stem cells on all fronts, whether they are human embryonic, adult, or cord blood -- since they were discovered. It is one of the central scientific challenges of our time," said Elias A. Zerhouni, M.D., NIH Director. "NIH will continue to consult widely with the scientific community to determine the best approaches."

"The Executive Order recognizes the recent developments in adult mouse cells that can be reprogrammed to behave like embryonic stem cells, and we've laid out a strategy to explore their possible applications to human cells," said Story Landis, Ph.D., Director of the National Institute of Neurological Disorders and Stroke. She also serves as the chair of the NIH Stem Cell Task Force.

The NIH plan includes a number of new or accelerated activities. For example, the NIH Stem Cell Task Force will develop several funding opportunity announcements, including a Program Announcement (PA).

The PA will ask for grant applications proposing research on human pluripotent stem cells derived from non-embryonic sources, such as somatic cells or cells found in amniotic fluid. In addition, the Stem Cell Task Force will create two supplement programs that will stimulate research in specific areas rapidly.

They would be awarded to researchers already working in stem cell research to augment certain areas of their work that are of particular interest to NIH. All research proposals will be subject to the standard peer review process.

The plan also calls for aggressively pursuing an assessment of the potential of alternative sources of pluripotent stem cell lines, including altered nuclear transfer; single cell embryo biopsy, and reprogramming, or dedifferentiation of somatic cells, such as skin cells. While these methods have been proposed, questions remain as to their feasibility.

To address this issue, the NIH will undertake a comprehensive research portfolio review to determine what research NIH is currently supporting in this area and convene a state-of-the-science workshop to identify the key questions. Some of the alternative methods may raise questions under applicable law. In such cases, NIH must carefully consider whether it may fund such research.

NIH will also hold a symposium that will explore what avenues of stem cell research eligible for funding under federal law and policy offer the greatest potential for clinical benefit.

Under the plan, NIH will rename its Human Embryonic Stem Cell Registry as the "Human Pluripotent Stem Cell Registry" and will consider the addition of new human pluripotent stem cell lines to the registry that are deemed eligible.