Are the Regenexx procedures performed in the U.S. approved by the FDA?
The FDA does not “approve” or “not approve” medical procedures (like gallbladder surgery for example). This is considered a medical procedure.
The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b).
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).
The Regenexx-C Procedure – What’s the Difference?
All of the procedures performed 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. This makes them compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b).
Regenexx®-C is a cultured stem cell procedure that is available only in the Cayman Islands. While our same-day stem cell protocol (described above) is the premier stem cell treatment available in the United States, some patients may benefit from the expanded numbers of cells that are delivered by a cultured stem cell procedure.
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.
[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.]
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