- Posted by agency-it
- On February 9, 2016
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 now performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure and has not been performed in the U.S. since August of 2010.
What’s the Difference Between these Procedures?
All of the procedures performed in Colorado and throughout our U.S. Regenexx Procedure Network 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.
Dr Chris Centeno explains the FDA’s stance on the Regenexx-C cultured stem cell procedure, which has not been performed in the United States since 2010 (currently offered by Regenexx Caymen):
[Disclaimer: The Regenexx™ same-day procedures are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]