A Professional Standard for Informed Consent for Stem Cell Therapies

ARTICLE: A Professional Standard for Informed Consent for Stem Cell Therapies

AUTHORS: Jeremy Sugarman, Roger A. Barker, R. Alta Charo

JOURNAL: JAMA. 2019 Aug 12. doi: 10.1001/jama.2019.11290. [Epub ahead of print]

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

Over the last decade, there has been an increase in the number of “clinics” (570 in the United States alone according to a recent estimate) offering what is portrayed as “stem cell therapy” for conditions ranging from orthopedic injuries to Alzheimer disease.2 The unproven nature of these interventions suggests that patients who received them were, at a minimum, misled. At worst, they were severely injured, as in the case of at least 3 women who were left legally blind after intravitreal injections of platelet-rich plasma derived from tissue obtained through liposuction.3

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