International Stem Cell Guidelines Revised, Expanded

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May 12 — Widely recognized stem cell research guidelines now address controversial topics such as human gene editing under a final update released May 12.

The decision by the International Society for Stem Cell Research to recommend that stem cell oversight bodies should review all embryo research comes from a recognition of rapidly advancing technologies that could make unprecedented advances in understanding human disease but also have ethical implications.

“We in the scientific community have to be vigilant—and also transparent—about the way we do the research,” George Q. Daley, a Harvard University stem cell scientist and ISSCR board member who helped craft the new guidelines, told Bloomberg BNA May 11.

The document is titled Guidelines for Stem Cell Science and Clinical Translation.

First Major Revision

The revised guidelines mark the first major revision since the society issued the initial set of guidelines in 2007 that address the laboratory side of stem cell research. The ISSCR a year later issued a separate set of guidelines on the clinical translation of stem cells (2 LSLR 1037, 12/5/08), and the society has now consolidated both guidelines into a single document as part of the 2016 update.

Similar to 2005 National Academies guidelines, the ISSCR recommended in those initial documents the creation of specific oversight committees at research institutions to oversee embryonic stem cell research. Under the 2016 update, these committees will oversee all embryo research.

“These guidelines are meant to provide not just the roadmap for practitioners, the scientists and clinicians, but also a window into the process of biomedical research for the public, so that they can be comfortable that this work is being done under very, very scrupulous and independent oversight,” Daley told Bloomberg BNA.

While they aren't legally binding, Daley, who is also the director of the Dana-Farber Cancer Institute Stem Cell Transplantation Program, said “the guidelines are really an attempt to be influential across the international community and in many cases to fill” the regulatory vacuum that exists in many countries.

The recommendation for new embryo research committees is a substantial change from the draft guidelines issued about a year ago, Daley said, due to feedback asking the ISSCR to be more precise in the nature of the research that needs specialized oversight. “We really moved to make it very clear,” Daley said, that when human embryos come into the discussion there needs to be special scrutiny of the research. “So we explicitly have now dubbed the process embryo research oversight.”

iPS Cell Exemption

The society also decided to exempt induced pluripotent stem (iPS) cells from oversight review because they aren't derived from embryos but rather are reprogrammed from other cells to act like embryonic stem cells. Under the new guidelines, iPS cells wouldn’t be subject to additional oversight from a stem cell panel, but would be reviewed under existing human subject protection requirements to oversee donor cell recruitment.

“There was a certain amount of confusion within the community as to whether iPS cells should be reviewed in the same way as embryonic stem cells,” Daley said. “Part of the update of the guidelines is to recognize that iPS cells don’t raise the same sensitivities as embryonic stem cells.”

In the guidelines, the ISSCR said it supports laboratory-based research that entails gene editing of the nuclear genomes of human sperm, eggs or embryos when performed under rigorous review. But the society also said that any attempt to apply these techniques clinically would be premature and should be prohibited at this time. .

Science ‘Hype' Addressed

Another new section in the guidelines calls for the responsible communication of stem cell science and medicine, so that scientists, clinicians, industry, science communicators and the media can present accurate, balanced reports of progress and setbacks.

Timothy Caulfield, a health law professor at the University of Alberta in Canada who helped write this new section, said it stems from concerns about science hype. “This is an issue that’s getting more and more attention,” Caulfield told Bloomberg BNA on May 9, noting that the John Oliver show ran a segment on science communication just one day earlier. “It’s particularly significant to stem cell research because it’s a field that’s received just so much attention.”

Caulfield also wrote a policy forum article in Science magazine in conjunction with the new guidelines. He said there's concern that exaggeration of claims of stem cell research could “lead to a misunderstanding in the public of the state of the science and perhaps facilitate the marketing of unproven therapies, which could be very problematic.”

To contact the reporter on this story: Jeannie Baumann in Washington jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin rkubetin@bna.com