Abstract

Over the past decade, the landscape of unproven stem cell-based interventions (SCBIs) has dramatically changed. Once perceived as only operating in countries with less developed health infrastructures, clinics advertising unproven SCBIs are now located in almost every developed country and their numbers are increasing despite regulatory authorities working to close the more unscrupulous and dangerous ones. In 2021, Leigh Turner from the University of California, Irvine, identified 2,752 clinics in the USA operated by 1,480 businesses, a 400% increase from the numbers of clinics reported in 2016. This SCBI marketplace remains largely unregulated despite evidence indicating that many interventions are ineffective and can increase risk for patients. Moreover, providing unproven interventions threatens legitimate stem cell clinical research, delaying—if not potentially preventing—the development of therapies for a variety of conditions. To address these risks to current and future patients, companies developing SCBIs should work with policymakers and patient advocates to protect clinical research and the reputation of the field.

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