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FDA scrutinizes human stem cell therapies

Nature Biotechnology volume 26, pages 598–599 (2008)Cite this article

Along with those 'deal-killer' risks loom other, more pragmatic questions about harnessing and delivering human embryonic stem (hES) cells for specific diseases and anatomic sites being treated; about lot production, purity and other quality control measures; and about appropriate animal models, clinical trial designs and other safeguards in testing and using such cells. Although committee members briefly considered requiring that suicide genes be incorporated into hES cells as a failsafe measure for protecting patients, they concluded that such schemes seem too technically complicated to enable implementation and might “cause more problems than [they] would solve.” Even so, there was wide agreement that hES recipients should be followed on a long-term basis for signs of cancer or other “unanticipated events.” Those conducting clinical trials with hES cells need to be vigilant for signs and symptoms that might arise, however unexpectedly, from the procedure. No one wants the cell therapy field to repeat the setback that gene therapy experienced following the death of Jesse Gelsinger, who died after receiving a single injection of an adenoviral vector. Indeed, only a month after the advisory panel emphasized the need for strict safety measures, on May 14, Geron, of Menlo Park, California received notice from the FDA that approval for its application to begin a clinical trial using hES cells for spinal cord injuries had been delayed. Thomas Okarma, Geron's president and chief executive officer, was “disappointed with the news,” particularly as the company has been in discussions with the FDA for the past four years. He had hoped that “the breadth and depth of the submission, some 21,000 pages, predicated on those discussions with the agency” would be enough for to the trial to go ahead.

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    Jeffrey L Fox

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Fox, J. FDA scrutinizes human stem cell therapies. Nat Biotechnol 26, 598–599 (2008). https://doi.org/10.1038/nbt0608-598

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