Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States

Abstract

Summary: There 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. : Frow and colleagues provide a detailed characterization of 169 direct-to-consumer stem cell businesses operating in the Southwest US. They identify differences in the degree to which individual clinics focus on providing stem cell treatments, and compare physician expertise with the types of conditions treated. These findings are used to offer suggestions for regulatory oversight of direct-to-consumer stem cell businesses. Keywords: stem cell clinics, direct-to-consumer treatments, FDA, policy, regulation