Regenexx procedures are not FDA approved. No stem cell or platelet-rich plasma therapy for orthopedic injuries has received FDA approval in the United States. Regenexx operates its U.S. clinics under a regulatory framework that allows certain cell-based procedures without formal approval, as long as they meet specific criteria for minimal processing. But the company has a complicated history with the FDA, including a lawsuit it lost.
How Regenexx Operates Without FDA Approval
The FDA regulates human cells and tissues under a set of rules that creates two tracks. If a cell-based product meets all four criteria in federal regulations, it can be used without going through the full drug approval process. Those criteria require that the cells are only minimally processed, used for the same basic function they serve naturally in the body, not combined with other substances (beyond simple solutions like saline), and either used in the same person they came from or don’t depend on living cell activity for their effect.
Regenexx’s U.S. procedures use your own bone marrow concentrate or blood platelets, processed in a lab and reinjected into the same patient during a same-day or multi-day procedure. Because the cells come from you and go back into you (autologous use), and because the company argues its processing qualifies as “minimal manipulation,” these procedures fall into the category that doesn’t require FDA approval. Regenexx states that the treatments offered at its U.S. clinics comply with FDA regulations.
This is not the same as being FDA approved. It means the FDA has not evaluated these procedures for safety or effectiveness through clinical trials. The distinction matters: FDA approval requires rigorous testing in controlled studies, while the regulatory exemption Regenexx relies on simply means the agency isn’t treating the procedure as a new drug.
The FDA Lawsuit That Changed Regenexx
Regenexx originally offered a more advanced procedure called Regenexx-C, which involved removing stem cells from a patient’s bone marrow, culturing and expanding them in a lab over several weeks, then reinjecting the larger quantity of cells. In 2010, Regenexx sued the FDA, arguing that the agency had no authority to regulate this procedure since it used a patient’s own cells.
Regenexx lost. The FDA countersued, charging that the cultured cell procedure amounted to manufacturing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, ruling that lab-culturing cells goes beyond minimal manipulation and transforms the product into something that requires full drug approval. The court forced Regenexx to stop performing the procedure in the United States.
Today, Regenexx offers the Regenexx-C cultured stem cell procedure only at its clinic in the Cayman Islands, where government regulation permits it. The Cayman Islands has become a known destination for medical tourism partly because of its lighter regulatory framework for these types of treatments.
What Regenexx Offers in the U.S.
The procedures available at Regenexx’s network of U.S. clinics involve same-day processing of your own cells. The company uses proprietary lab techniques that it says go beyond what a standard bedside centrifuge can achieve. For platelet-rich plasma treatments, Regenexx claims its processing removes nearly all white and red blood cells and produces a concentration three to five times higher than what basic centrifuge machines deliver. The company also uses a platelet-lysate processing method designed to release growth factors more quickly.
These are meaningful technical differences from what many orthopedic clinics offer, but they don’t change the regulatory picture. None of these procedures have been through FDA clinical trials or received FDA approval.
The Broader FDA Position on Stem Cell Therapies
The FDA has been increasingly vocal about the gap between marketing claims and regulatory reality in regenerative medicine. The agency notes that clinics broadly market unapproved regenerative medicine products for a wide range of diseases, even though these products haven’t been studied in the controlled trials needed to demonstrate safety and effectiveness.
As of now, the only stem cell products with FDA approval in the United States are blood-forming stem cells derived from umbilical cord blood, and those are approved solely for blood disorders. They are not approved for orthopedic use, pain management, or any of the conditions that clinics like Regenexx typically treat.
The FDA has repeatedly notified manufacturers, clinics, and practitioners that administering unapproved regenerative medicine products legally requires an Investigational New Drug application, which places the treatment within a formal clinical trial framework with safety oversight.
Insurance and Out-of-Pocket Costs
Most health insurance plans do not cover Regenexx procedures, which means patients typically pay out of pocket. However, some self-funded employer health plans have begun including Regenexx as a covered benefit. Larimer County in Colorado, for example, covers Regenexx services at 100% under its PPO health plans with no deductibles, copays, or coinsurance. Under its high-deductible plan, coverage kicks in at 100% after the deductible is met.
These employer-sponsored arrangements are still uncommon. If you’re considering a Regenexx procedure, expect to pay the full cost yourself unless your specific employer plan has negotiated coverage. The lack of FDA approval is one reason most traditional insurers don’t cover it: without the clinical trial data that approval requires, insurers generally classify these procedures as experimental.