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Abstract
SummaryThere are currently hundreds of businesses across the United States offering direct-to-consumer stem cell treatments that have not been through regulatory approval by the Food and Drug Administration (FDA). Here, we provide a detailed characterization of nearly 170 stem cell businesses operating in the Southwest United States. We draw specific attention to two as-yet understudied facets of these businesses. First, we identify differences in the degree to which a given business focuses their practice on stem cell treatments. Second, we compare the stated expertise of the care providers in stem cell businesses with the range of conditions they purport to treat. These findings deepen our knowledge of the growing industry around unapproved stem cell treatments, and are used here to offer suggestions for how the FDA might target its resources with respect to regulatory oversight.
Highlights
Recent years have seen growing attention paid to the rapid rise of clinics offering direct-to-consumer stem cell treatments that have not gone through approval by the Food and Drug Administration (FDA)
We explore the issue of medical expertise, comparing the specialties of care providers practicing at clinics focused solely on stem cell treatments with the conditions they purport to treat
Stem Cell Types and Conditions Treated Our results broadly corroborate the findings of Turner and Knoepfler (2016), with adipose tissue being the stated source of stem cells for nearly two-thirds of the stem cell businesses, and bone marrow used by almost half (Figure 1A)
Summary
Recent years have seen growing attention paid to the rapid rise of clinics offering direct-to-consumer stem cell treatments that have not gone through approval by the Food and Drug Administration (FDA). These developments are being tracked by the academic community in various ways, including studies tracing the rise of these clinics (Knoepfler and Turner, 2018), characterizing the conditions they offer to treat (Lau et al, 2008; Turner and Knoepfler, 2016) and their marketing practices (Knoepfler, 2017; Sipp et al, 2017), and analyzing press coverage of celebrities who have had experimental stem cell treatments (Rachul and Caulfield, 2015). We suggest that understanding the links between provider expertise and stem cell treatments could provide useful information for patients and regulators
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