Out With the Old, In With the New?

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Science  26 Jun 2009:
Vol. 324, Issue 5935, pp. 1617
DOI: 10.1126/science.1177267

President Obama's recent announcement of a new policy for Federal Funding of stem cell research changes the landscape for this important area of biomedicine in the United States. His Executive Order and the subsequent draft guidelines of the National Institutes of Health (NIH) remove a major existing limitation on federal support for research using pluripotent human embryonic stem cells (hESCs). These stem cells can specialize into all body cell types. Thus, in principle they can be used to produce a wide range of tissues for therapeutic use. In addition, their study will very likely generate new insights into human early developmental mechanisms. The new Obama policy promises to speed research by making many new hESC lines eligible for federally funded studies. But the draft NIH guidelines accompanying the new policy need revision, because their donor consent rules for embryos used to generate hESCs would make some—and perhaps even all—of the previously approved hESCs ineligible for further federal funding. This would needlessly hinder progress in the stem cell field, and reasonable exceptions should be made to correct this unintended outcome.


President Bush's stem cell funding policy, in place since 2001, made a total of 21 hESC lines eligible for federal research funding. Because all of those lines had been exposed to animal cells and serum during their derivation and growth, they have limited value for clinical applications. More recently, hESC lines have been generated without being exposed to animal products, and these are more likely to be compatible with therapeutic use. In addition, they provide greater genetic diversity, making them more representative of patient populations. The federal funding to be made available for hESC research under the new guidelines places U.S. stem cell researchers on an equal footing with researchers in the UK and elsewhere, who have enjoyed access to such new and improved hESC lines for the past 8 years. New collaborations now become possible that will speed the research in this field. These include basic research by multiple researchers using clinically compatible hESC lines, which can culminate in their therapeutic use. Thus, the new U.S. policy will be important both for stem cell research and for the patients who are its future beneficiaries.

The new policy and guidelines also attempt to correct shortcomings in donor consent for federally eligible hESC lines. Doubts about the ethical status of the previously eligible hESC lines were raised by Streiffer,* who obtained anonymized patient consents for all 21 eligible lines through the U.S. Freedom of Information Act. U.S. standards for donor consent in the derivation of hESCs from human embryos were established by the National Academy of Sciences (NAS) in 2005. None of the 21 lines meets all these standards, and some lines fall far short. But the previously eligible hESC lines have now been used in hundreds of studies, providing benchmarks for the pluripotent stem cell field. The NIH draft guidelines reaffirm most of the NAS consent requirements, seemingly making the previously eligible lines ineligible under the new policy. Revisions in the draft NIH guidelines are thus necessary to retain eligibility for federal funding for the less ethically problematic of the widely used hESC lines.

Many researchers have recently been redirecting their attention to pluripotent stem cells that are induced from specialized cells. First described in 2006 by Japanese researchers, induced pluripotent stem cells are appealing both for their unlimited genetic diversity and for their reduced ethical complexity. However, it is still unclear whether human induced pluripotent stem cells have the necessary properties to qualify them for future therapeutic uses. Therefore, caution is needed in drafting new U.S. stem cell funding policies to avoid the unintended consequence of reducing, rather than expanding, the options available for research on hESCs that could lead to treatment of diseases.

  • * R. Streiffer, Hastings Center Rep. 38, 40 (2008).

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