New FDA Guidances Tighten Regulation of Stem Cells

S. Raymond Golish, MD, PhD, MBA; J. Tracy Watson, MD; William M. Mihalko, MD, PhD

Legitimate stem cell research may eventually revolutionize regenerative medicine, and some innovative therapies have already been appropriately studied and commercialized. By comparison, cell and tissue therapies promoted for orthopaedic conditions have often been poorly studied and lightly regulated. Nonetheless, they have proliferated commercially in the medical device market and in so-called stem cell clinics offering autologous, point-of-care interventional procedures.