The burgeoning U.S. stem cell therapy industry was delivered a setback last month in the form of a U.S. District Court injunction against use of the “Regenexx™ Procedure,” which purports to treat joint, muscle, tendon or bone pain due to injury or other conditions. The court agreed with the FDA that the cell product used in the procedure is both a drug and a “biological product” subject to FDA regulation. Because a similar process is used in other stem cell therapies the decision increases the possibility that the FDA will take a like position in other cases.
The general term “stem cell therapy” comprises an array of treatments which range from the clinically proven to quackery. On one end of the spectrum is blood stem cell transplantation to treat diseases and conditions of the blood and immune system. On the other lies the kind of stem cell therapy tourism addressed by both Steve Novella (here and here) and Orac (here and here), which involves the injection of what may, or may not be, stem cells from what may, or may not be, humans. In between fall therapies which are plausible and have promise but have not been adequately tested in clinical trials. There is a concern that these therapies are being oversold by clinics which charge thousands of dollars (not reimbursed by insurance) to treat conditions including multiple sclerosis, musculoskeletal pain, and cardiac disease.
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