FDA Information on Regenexx Procedures
Are the Regenexx procedures performed in the U.S. approved by the FDA?
The FDA does not “approve” or “not approve” medical procedures (like gall bladder surgery for example). Regenexx is considered a medical procedure. We are in compliance with all procedure codes; the FDA does not have any issues with the procedures we offer in the U.S.
All of the Regenexx Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b). Unfortunately, there still remains some confusion about Regenexx, largely as a result of a few individuals who have written about our case against the FDA throughout the last few years, but who did not fully understand that the case relates only to the Regenexx-C Procedure. This single procedure, which is different from the procedures performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure. This procedure has not been performed in the U.S. since August of 2010.
What’s the Difference Between the United States Procedures and the Regenexx Cayman Procedures?
All of the procedures performed in the United States are same-day procedures. This means that the patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours. The Regenexx-C Procedure, which is only performed at Regenexx Cayman, involves harvesting the cells on the patient’s first visit, growing them to larger numbers over approximately two weeks, testing the cells, then re-injecting the cells during the patient’s second visit.