Proposed NIH Stem Cell Guidelines Dismay - Stanford Researcher

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Irving Weissman, MD, director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine, said the SCNT technique is one way to create disease-specific human embryonic stem cell lines on which to conduct research and test therapies. He also took issue with the assertion that the NIH consulted existing guidelines from the National Academy of Sciences and the International Society for Stem Cell Research both of which sanction the use of SCNT-derived cell lines in coming up with its draft recommendations.

"Instead of facts, the NIH placed its own version of ethics in place of the president's clear proclamation," said Weissman, the Virginia & D.K. Ludwig Professor for Clinical Investigation in Cancer Research. "As head of the National Academy of Sciences' panel that unanimously endorsed research using SCNT, and as a drafter of the guidelines for the International Society for Stem Cell Research, I know that this suggested ban on federal funding of SCNT-derived human embryonic stem cell lines is against our policies and against President Obama's March 9 comments. The NIH has not served its president well."

On March 9, President Barack Obama signed an executive order removing previous restrictions on the use of federal funds for research on any human embryonic stem cell line derived after Aug. 9, 2001. He used the ceremony to remark that it is important to ensure "that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions based on facts, not ideology."

In announcing the draft guidelines, acting NIH director Raynard Kington, MD, PhD, justified the restriction in part by saying that there is a lack of scientific consensus as to the necessity of funding lines derived by SCNT and that, although the technique has been used to create many embryonic stem cell lines in animals, such human embryonic stem cell lines have not yet been documented.

"We believe there is strong, broad public and scientific support for the use of federal funds for research on cell lines from embryos derived through in vitro fertilization for reproductive purposes that would not otherwise be used," said Kington, noting that similar legislation had twice passed both the House and Senate only to be vetoed by former President George W. Bush. "We do not see similar broad support for using federal funding for research on cell lines from other sources."

The somatic cell nuclear transfer technique involves removing the nucleus from an egg cell and replacing it with a nucleus from a different cell in order to create an embryonic stem cell line genetically identical to the donor nucleus. In the case of a donor who suffers from a condition like Parkinson's disease, the SCNT process would yield an embryonic stem cell line that could be used to test specific therapies for that patient.

If the draft guidelines are adopted, they would underscore the continued need for the California Institute for Regenerative Medicine, which has funded grants to several scientists working to create specific human embryonic stem cell lines for research purposes. The institute was established in 2005 by Proposition 71 to counteract the effect of President Bush's limits on federal funding of such research.

"Methods like SCNT were specifically sanctioned by Prop. 71," said Geoff Lomax, PhD, the senior officer to the state institute's Standards Working Group, which was instituted to develop ethical guidelines for the use of embryos in CIRM-funded research. "These potential restrictions on the range of research materials available for federal funding ensure that CIRM will continue to play a unique role in the world of stem cell research."

"For certain types of research, CIRM could remain very important," concurred Renee Reijo-Pera, PhD, director of Stanford's Center for Human Embryonic Stem Cell Research and Education. Reijo-Pera said she had expected the NIH guidelines to be somewhat conservative, particularly where SCNT is concerned.

"I am happy that these are draft guidelines," said Weissman, who noted that the NIH did not solicit input from either the National Academy of Sciences or the International Society for Stem Cell Research during the consensus process. "I'd like to remind the NIH of the principles enunciated by the president on March 9. Research in this area is moving very fast, and it's not possible to say whether advances will come from work on adult-derived iPS cells or from embryonic stem cells created by nuclear transfer. Policy needs to be developed as the field develops, rather than precluding something based on ideology."

The proposed NIH guidelines will be available for public comment for 30 days, and the final guidelines will be released by the agency on or before July 7. They can be viewed at stemcells.nih.gov/policy/2009draft - Comments can be mailed, or submitted electronically after the guidelines are published in the Federal Register by April 24.