The FDA flexed its regulatory muscle twice this past summer in going after a pair of medical clinics offering unapproved and potentially dangerous stem cell therapies to patients. Materials were seized from one clinic in California, while another in Florida received a warning letter after three patients were injured by stem cell treatments. It is important that the FDA action be viewed in the correct context rather than interpreting it as proof that regenerative medicine is illegitimate.
Regenerative medicine is a field of medicine that uses things like platelet-rich plasma (PRP) and stem cell therapies to promote natural healing. It is not new. Despite the impression given in some media reports, the concept of regenerative medicine has been around for decades. One of the earliest approved forms of regenerative medicine, using stem cells harvested from bone marrow to treat leukemia, has been in use since the 1970s.
The important thing to know and understand is that the two targeted clinics were performing procedures that were both dangerous and lacking any foundation in scientific evidence. Those procedures are a far cry from the orthopedic and aesthetic procedures doctors across the country are employing both safely and effectively.
The Autologous Factor
A person hearing about the FDA action for the first time may wonder how medical clinics can get away with offering procedures that are not FDA approved. The answer can be encapsulated in a single phrase: ‘the autologous factor’.
The stem cell material both clinics were using is autologous material. In other words, it is biological material extracted directly from the patient being treated. In the FDA-approved process of using bone marrow material to treat leukemia, the material can be taken directly from the patient being treated, then processed and returned to the patient via injection.
Under normal circumstances, autologous material is considered safe because there is almost no risk of rejection or complication. As long as clinics are following FDA standards for extracting, processing, and injecting autologous material, the specific procedures they offer do not need to be further approved after extensive clinical testing.
So what is the problem? Why were the California and Florida clinics subject to FDA action? Because the procedures they were offering went above and beyond the scope of what the FDA already considers acceptable. For example, the California clinic was offering a cure for cancer that is both unproven and highly questionable. The Florida clinic was using stem cells to treat macular degeneration in a way that runs afoul of FDA standards.
Aesthetic and Orthopedic Procedures
A distinction has to be made between the questionable procedures targeted by the FDA and the aesthetic and orthopedic procedures doctors practice every day. According to Advanced Regenerative Medicine Institute (ARMI), a Utah company that trains doctors in regenerative medicine procedures, the differences are like night and day.
Orthopedic and aesthetic applications of stem cell therapy and its PRP cousin are not unproven. Medical science has long known the basics of how both stem cells and PRP function. Current orthopedic and aesthetic procedures are based on that widely accepted body of knowledge.
Like any other industry, healthcare has its practitioners willing to engage in questionable and sometimes dangerous practices. But the actions of two clinics are not representative of the hundreds of doctors and clinics offering regenerative medicine for orthopedic and aesthetic purposes. In short, the FDA action against those two clinics in no way suggests that regenerative medicine is illegitimate. To accept it as such is to do a tremendous disservice to the doctors who use regenerative medicine safely and within FDA standards.