An afternoon session at the World Stem Cell Summit turned its attention to legal and policy issues impacting stem cell research. Beth Roxland from the Hofstra University Bioethics Center described a lawsuit (Feminists Choosing Life v. Empire State Stem Cell Board) against New York's stem cell research program. The lawsuit had to do with New York's funding of what's commonly known as therapeutic cloning, or somatic cell nuclear reprogramming (SCNT). This is the technique that was used to create cloned animals such as Dolly the sheep, but can also be used to create embryonic stem cells in many types of animals. So far, nobody has succeeded in creating human embryonic stem cells through SCNT.
The basic argument by Feminists Choosing Life was that SCNT research indirectly supports human reproductive cloning. New York, like California, has explicit language in their law banning reproductive cloning. Feminists Choosing Life attempted to argue that SCNT research may result in knowledge that would allow others to attempt reproductive cloning in the future. Fortunately, the court found the explicit ban clear and compelling and that the reasoning of indirect support was speculative and not grounds for preventing legitimate stem cell research.
Roxland then turned her attention to Federal legal issues. Keep in mind this is a national meeting and many of the participants come from state that do not have comprehensive laws like California and New York, so federal laws have a major impact. She described August 2012 Federal Appeals court decision unanimously upholding the current NIH policy for allowing human embryonic stem cell research. She noted that the decision has been appealed to the Supreme Court so we will not know if the Appeals Court decision holds until early 2013.
Matthew Vincent of Advance Cell Technology then discussed how the Federal policy environment has impacted ACT's work on developing hESC-based treatments for people with macular degeneration. Before discussion policy issues, Vincent first described how one patient receiving the treatment has visual gains and continues to show improvement (we blogged about those findings here). Matthew described how ongoing litigation and federal policy governing hESCs has resulted in the company not using Federal funds. Vincent said, “There is a lot more we could have done” were it not for Federal policy considerations. The good news is that if the Appeals Court decision holds then the path may be cleared for more research.