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Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft guidance documents that have been issued by FDA in recent years. It then turns to some very recent FDA enforcement efforts targeting specific stem cell clinics in Florida and California that have been providing largely unregulated and unproven stem cell treatments, sometimes with catastrophic results. The article concludes by looking at some recent statements coming from FDA’s Commissioner indicating that the agency intends to create a more coherent and defined regulatory framework for regenerative medicine in an attempt to facilitate the development and availability of legitimate stem cell therapy, while cracking down on bad actors that are putting patients at risk and tarnishing the public’s perception of stem cell therapy in general.

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Biotechnology Law Report