FDA regulation of adipose cell use in clinical trials and clinical translation

Abstract This chapter discusses United States Food and Drug Administration (FDA) regulation of adipose-derived stem cell therapies. It begins with the basic facts of what adipose is and what it does (while leaving more detailed discussions to other parts of this publication). It then summarizes the basics of law and regulation as applied to regenerative medicine and describes the FDA's overall risk-based framework for regulating cell therapies. This is followed by a closer examination of the FDA's specific regulation of adipose-derived cell and tissue products. The agency's missteps are identified, and their repercussions for the regulated as well as the regulator are considered. The chapter closes with a brief overview of recent developments in methods and mechanisms for obtaining approval of regenerative products and biologics in general, particularly with regard to real-world evidence and innovative trial design. While not limited to adipose products, this material is potentially relevant to those working in this area.