The FDA and Stem Cells

Can Cell Therapy Work for Me?

Are you thinking of having a stem cell procedure? If so there are lots of things to consider like who is offering the procedure? What is their experience? And most importantly, is it reasonable to believe  stem cell therapy can work?

One other thing you might wonder is What does the FDA think about stem cell treatments?


First, it is important for you to understand that the only “FDA approved” stem cell therapy is the one used to used treat cancers like leukemia. However comments made by former FDA commissioner Scott Gottlieb, suggests that the FDA recognizes the incredible potential of cell therapy. 

Scott Gottlieb, while chairman of the FDA, made his thoughts on stem cell clear:

We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; …… adult stem cells can generate replacements for cells that are lost to injury or disease.

The ability to facilitate the regeneration of parts of the human body is no longer the stuff of science fiction, the cell based therapies and their use in regenerative medicine is one of the most promising fields of science already producing improbable advances.

Clearly the commissioner understands the incredible promise of stem cell.


Even though the FDA may recognize the enormous potential of cellular therapy, their first mission must be to protect the public. The number of stem cell clinics in the U.S. has risen exponentially over the past few years and many of these clinics are run by poorly qualified providers (often non-physicians) with little experience. Some clinics make ridiculous comments suggesting they have the ability to heal dementia, multiple sclerosis, and even blindness. Because of this, in 2017 the FDA issued guidance on how clinics can operate, under what conditions, and using which products.

The FDA recognizes the industry built around regenerative medicine and stem cells needs to be regulated. With that in mind, the FDA commented in the fall of 2017, giving their long term regulatory plans. In those documents, the they suggested that in the future they will only allow autologous and homolgous stem. Now what exactly that means is still a question to many of us, but it may mean only a patient’s own cells may be used, and only for the “purpose originally intended”. If you are confused, don’t feel alone.


Beginning in November 2017 the FDA allowed a 36 month period, in which they will not seek to enforce these directives. Their statement suggests that soon the only cells doctors can use will be cells from the patient, unless providers of allogenic (donated cells) can show studies similar to that which drug manufacturers must show, proving their product is safe and efficacious.  Will clinics using a patients own cells be allowed to remain in business?  Well at this point, no one is sure, but most providers believe this is likely.

You can read the complete FDA documents below:




In our practice, above all else, we believe in the ethical practice of medicine. I have spent over twenty years treating spine and joint pain and have seen the poor surgical outcomes and miserable options that we offer patients now. I see regenerative options as an incredible breakthrough with the potential to help many patients. PRP has proven effective in many applications but I think the potential of bone marrow (and possibly fat) cellular therapy is even greater. We constantly review the literature to look for the newest, safest, best options, and studies like the one Hernigou published last year strongly suggest that cell therapy is a reasonable option.

The FDA clearly has the need to police medicine, but it is our hope that reasonable treatments like those studied by Orthopedic surgeon Phillipe Hernigou will continue to give patients a chance for pain relief without surgery.



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