![]() ![]() Arnie is funny, irreverent, and has an uncanny ability to take complex hard science topics and make them digestible for physicians. One of my favorite lecturers on the face of the earth is Arnie Caplan, who is arguably the discoverer of what we currently call “mesenchymal stem cells” (MSCs) (4). Find a Location The Scientific Debate Behind the Term “Stem Cell” Having said all of that, my focus here will be on the science and not on the regulatory argument.Ĩ5 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. ![]() This has made it difficult for legit medical providers offering orthobiologic treatments as they are often the baby getting thrown out with the proverbial bathwater. The biggest offenders were clinics using demonstrably dead cell birth tissue therapies and advertising these as live stem cell therapies (19-22). On the other hand, many companies are pursuing multi-year expensive clinical trials to get the legal right to market stem cell therapy as an FDA-regulated drug.Īlso, realize that we got here to what I call the “stem cell wild west” with an FDA sensitized to this issue because of a raft of companies offering to treat every known disease with “stem cell therapy”. On the one hand, multiple court cases have determined that society benefits from doctors being free to use whatever works to help patients and to describe that in any way that helps patients conceptualize the therapy (1-3). Given that our company both has affiliate clinics that use orthobiologics and also has several orthobiologic drug candidates in front of the FDA, I can see both sides of that argument. While the recent loss by the FDA at the hands of judge Bernal in LA regarding classifying adipose stromal vascular fraction as a drug has shaken that space up a bit, reading countless FDA documents makes it clear that the agency doesn’t like companies and practitioners using this terminology to describe treatment: It’s very clear that the FDA and FTC do not like physicians using the term “stem cell therapy”. I’ll cover the concept that bone marrow concentrate contains stem cells and that our current understanding of its mechanism of action is tied to that stem cell content. Today I’ll review the pure science of whether bone marrow concentrate is a stem cell therapy. It’s also been an interesting scientific ride as well. This has been an interesting few years with regard to the regulations behind using the term “stem cell therapy”. ![]()
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