We must caution the consumer to be wary of “clinics” that promise to deliver curative stem cell therapies, and to exercise extreme caution when considering enrollment in a clinical trial being offered by a “stem cell clinic.” It falls to the consumer to investigate whether the clinical trial is being conducted with FDA oversight, or whether a “therapy” accompanied by numerous testimonials has been scientifically proven safe, effective, and FDA-approved.
Fortunately, oversight of “stem cell clinics” is increasing. On Thursday, March 22, Governor Inslee signed into law House Bill 2356. This legislation will require Washington State “stem-cell clinics” to post a visible notice that their injection procedures are not FDA-approved and that patients should consult with primary-care providers before undergoing one.
At this point in time only a few FDA-approved stem cell-based treatments are available. One such treatment is the use of blood stem cells and umbilical cord stem cells to treat and even cure individuals with blood cancers such as leukemia.
The methodology used by most of the “stem cell clinics” currently advertising available therapies is to remove adult stem cells from one part of a person’s body, minimally process the cells, and then inject the cells into another part of their body. This use of adult stem cells has never been vigorously tested. It has never been demonstrated to be safe or even effective. These widely-advertised “clinics” are able to circumvent the FDA because they minimally manipulate the cells, a regulatory loophole that enables them to offer this “treatment” without regulatory oversight.
A highly publicized article in the New England Journal of Medicine reported cases of severe vision loss in patients with macular degeneration who had received injections of their own adipose stem cells into their eyes. *The injections were conducted by a Florida “stem cell clinic” under the auspices of a clinical trial that had not been reviewed by the FDA.
Take care of yourself!