This past month there were some big news stories on illegal fat stem cell clinics. These are clinics that digest fat tissue to isolate stem cells, something the FDA has said isn’t allowed as they believe that this constitutes the production of a new drug without approval. I had a reader ping me on the difference between Regenexx and these clinics, so I created the above “Regenexx vs Illegal Fat Stem Cell Clinics” infographic to hit the high points of that comparison.
First, why are same day bone marrow stem cell procedures allowed when these fat clinics are illegal? The FDA has stated that while isolating platelets from blood or stem cells from bone marrow can be performed using “minimal manipulation” and still be considered the practice of medicine, the isolation of stem cells from fat is over that line. Why? The latter’s stem cells are locked inside fat tissue and that structure must be broken down via chemical or other means to get the stem cells out. It’s this last part that the FDA believes crosses from the practice of medicine into illegal drug production.
There are medical clinics using fat in a compliant manner. In that case they don’t try to breakdown the cellular structure of the tissue using chemicals, they just perform minimal processing on that tissue and inject it for structural purposes. Since this type of fat procedure doesn’t lend itself to IV infusion, you can always tell an illegal clinic by the fact that they offer stem cells through an IV treatment. In addition, most clinics that only offer orthopedic treatments are usually compliant, as illegal fat stem cell clinics are usually those who offer to treat a wide variety of ailments including cardiac, neurological, pulmonary and other diseases.
The upshot? Illegal fat stem cell clinics abound right now. While there is no doctor in America who wished more that a broad array of therapies that were safe and helped patients were being responsibly delivered to patients and that this was all regulated strictly as the practice of medicine, that never came to pass. In the meantime, while there may be good providers out there offering illegal fat stem cell therapies, the bad providers have tarnished the field so badly that regrettably the baby is getting thrown out with the bathwater. These bad providers offer to treat anyone with a credit card rather than looking critically at good or bad candidates for the therapy. They use research as a marketing tool, rather than actually publishing any research data. They train any doctor who wants to make a few quick bucks rather than trying to discern if the doctor is qualified to treat the conditions being offered on the menu. Finally, they make no attempt to track nor transparently report side effects or complications, despite rumblings of serious complications being sustained by patients. In the end, instead of a sane and safe technology explosion in stem cells being offered by responsible physicians, we’ve gotten the worst of the wild, wild west!