Research Article

Safety and efficacy claims made by US businesses marketing purported stem cell treatments and exosome therapies

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Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

Department of Health, Society, & Behavior, University of California, Irvine, CA 92697-3957, USA

Sue & Bill Gross Stem Cell Research Center, University of California, Irvine, CA 92697, USA

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Juan Ramon Martinez

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

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Shemms Najjar

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

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Thevin Rajapaksha Arachchilage

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

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Victoria Sahrai

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

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Jia Chieng Wang

Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA

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Published Online:5 Oct 2023https://doi.org/10.2217/rme-2023-0118

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Abstract

Aim: Examining websites of US businesses engaged in direct-to-consumer advertising of putative stem cell treatments and exosome therapies, this study investigated the marketing claims such companies make about the purported safety and efficacy of these products. Methods: Data mining and content analysis of company websites were used to identify and analyze safety and efficacy claims. Results: Of the 978 businesses analyzed, less than half the companies made identifiable claims about the safety and efficacy of their advertised stem cell and exosome products. We also explored how companies framed the stem cell and exosome products they promoted. Representations ranged from assertions that such products are unproven and investigational to claims they constituted cures. Most advertising frames fell between these poles. Conclusion: Some businesses include in their marketing representations claims about the safety and efficacy of advertised products. Businesses that did not make such assertions use other techniques to attract prospective clients.

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Vol. 18, No. 10

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History

Received 13 June 2023

Accepted 11 September 2023

Published online 5 October 2023

Published in print October 2023

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Author contributions

All listed authors meet the journal criteria for authorship.

Acknowledgments

Support for this project was provided by The Pew Charitable Trusts. We thank L Richardson, former Director of The Pew Charitable Trusts Health Care Products Project, for her support for this research project and the broader research program of which it is a part. The views expressed herein are those of the authors and do not necessarily reflect the views of The Pew Charitable Trusts.

Financial disclosure

Funding for this research was provided by The Pew Charitable Trusts. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

L Turner has served as an expert witness in two cases. In one case he was a pro bono expert for plaintiffs in a class action lawsuit. In second case he was a compensated expert witness for the prosecution, the US Department of Justice. L Turner is a member of the International Society for Stem Cell Research and the International Society for Cell and Gene Therapy, and serves as a member of ISSCR and ISCT's respective ethics committees. The other authors have no financial conflicts of interest or other actual or potential conflicts of interest to disclose. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

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