Surprise, Surprise: The FDA is Losing Big Time the War against Unregulated Stem Cell Clinics
Since stem cells and other HCT/P’s have come into clinical use in the early 2000s, (starting with one of my maverick doctor clients in the South), the FDA has attempted to regulate the field. Early on, the FDA adopted HCT/P regulations, that would be 21 CRF 1271. These regs made clear that allogeneic and expanded/cultured stem cells were regulated as new drugs. HOwever, there was one giant hole in the regulations, that being autologous, same surgical procedures. That hole in…