These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in a locale near me.
Tomorrow, July 11, reportedly the Irvine Stem Cell Treatment Center will open a Sacramento, CA branch. The doctor there will apparently be Thomas A. Gionis (picture from press release). This private, for-profit clinic has no affiliation with UC Davis School of Medicine in Sacramento where I’m located.
The stem cell clinic Sacramento branch will sell transplants of fat stem cells in the form of something called stromal vascular fraction or SVF, which I believe is almost certainly a drug. To my knowledge this clinic and the large chain that it belongs to called Cell Surgical Network (CSN), do not have FDA approval to use SVF.
Both publicly and to me on this blog, CSN continues to argue that it doesn’t need FDA approval (here, here and here), but recent FDA draft guidances sure suggest otherwise in my view. Of course if the FDA never takes action on the use of SVF then how are we all supposed to interpret that? Without FDA action or finalized guidelines, is it formally possible that the FDA could back down on SVF?
This clinic will reportedly sell SVF to treat a dizzying array of conditions having nothing to do with fat:
“Emphysema, COPD, Asthma, Heart Failure, Heart Attack, Parkinson’s Disease, Stroke, Traumatic Brain Injury, Lou Gehrig’s Disease, Multiple Sclerosis, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Muscular Dystrophy, Inflammatory Myopathies, and Degenerative Orthopedic Joint Conditions (Knee, Shoulder, Hip, Spine).”
To me as a scientist the use of SVF to treat all these very different conditions does not make good common sense.
It would also seem arguably to be quite likely be considered “non-homologous use” by the FDA, a standing that would also automatically make this a drug requiring FDA pre-approval. Non-homologous use means using a biological product of a certain kind that is not homologous (not the same or similar in origin) to the tissue being treated. For example, fat is not the same as the brain or other central nervous system tissue that is involved in several of the conditions on the clinic menu. Same goes for cardiac muscle, airways, etc.
The use of a non-FDA approved product in a largely non-homologous manner increases risks for patients. Note that these stem cell transplants are also very expensive with little evidence in the way of published data of benefit.
The CSN stem cell clinic in Sacramento will be located at the New Body MD Surgical Center, just about 10 minutes from my office. I plan on paying them a visit at some point. Let’s see how that goes. Will they let me in?