In November 2018, the US Food and Drug Administration (FDA) issued a press release that stated: “The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products.”1
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Sugarman J, Barker RA, Charo RA. A Professional Standard for Informed Consent for Stem Cell Therapies. JAMA. Published online August 12, 2019. doi:10.1001/jama.2019.11290
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