Typically, when patients go to a doctor they are seeking for a problem to either be improved or resolved; unfortunately, this is not always the outcome. According to an article in The New York Times, three elderly women with macular degeneration went to a vision clinic in Florida possessing at least partial vision. However, after treating at this clinic, one of the women went blind and the other two lost a considerable amount of their eyesight. Before the procedures, the women had vision deficiencies, but they could at least drive a car. The ladies underwent stem cell injections in 2015 at a clinic that is now called U.S. Stem Cell, and at this clinic, fat is taken out of the women’s stomachs and then stem cells are extracted from this and put into their eyes. The company claimed that they did not require FDA approval as the patients were being treated with their own stem cells, which aren’t classified as a drug.
According this same New York Times Article, regulations state that stem cells don’t require FDA approval if they are the patient’s stem cells and those stem cells are only “minimally manipulated”, but the question becomes: what qualifies as minimally manipulated? Troublingly, it appears that at the time, this company had found some sort of legal loophole, as they haven’t had any other penalties aside from being sued by two of the eye patients.
There are multiple different avenues to take to find companies that perform stem-cell treatments, and some of them are misleading. All three women discovered U.S. Stem Cell because one of their studies was on clinicaltrials.gov. According to the New York Times article, clinical trials don’t need to be approved by the government to be listed on their website. The chief science officer of U.S. Stem Cell, Kristin Comella, has announced that the company is no longer treating eyes, but they continue to treat people for other ailments. Hundreds of similar clinics are appearing all over the country, and concerned researchers have been warning people against these types of facilities with poor regulations and big promises.
Some other ailments that people are claiming to treat with stem cells include: injured knees, arthritis, heart failure and damaged spinal discs. Frighteningly, an article in The New England Journal of Medicine proposes that negative events transpiring from stem-cell treatments are “probably much more common than is appreciated, because there is no reporting requirement when these therapies are administered outside clinical investigations”. According to an article in Healthline, other negative outcomes that could result from stem-cell treatments include tumors and lesions, and this can even occur with less extreme procedures, such as therapy for anti-aging.
A new, unproven technology coupled with a lack of reporting requirements is generally a mishap waiting to happen. If you or a loved one have suffered from a negative outcome because of stem-cell treatment(s), please call my office for a free consultation.
New York Times- March 16, 2017, A16 of the New York edition with the headline: After Stem Cell Shots in Their Eyes, 3 Patients in Florida Lose Vision.