Three women who believed they were participating in a clinical trial either lost all or most of their vision after being injected with stem cells derived from their own fat in a Florida clinic. The case points to the dangers of unproven treatments offered by private clinics.
Within days of treatment the women, who all suffered from macular degeneration, began to experience severe side effects including bleeding in the eye, detached retinas and vision loss as reported in a study released week in The New England Journal of Medicine. Expert ophthalmologists tried to reverse the damage but were unable.
“There’s a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous” said Dr. Thomas Alibini, a lead author of the study, in a press release.
This isn’t the first time there have been adverse reactions to unproven treatments offered at clinics, many using stem cells drawn from the patient’s own fat, and we’ve written about it several times on this blog warning patients to be cautious of claims that appear too good to be true.
So how can patients protect themselves? The California Institute of Regenerative Medicine offers this advice:
- There is almost no evidence that the fat/blood stem cell combination the clinic used could help repair the photoreceptor cells in the eye that are attacked in macular degeneration.
- The clinic charged the women $5,000 for the procedure. Usually in Food and Drug Administration (FDA)-approved trials the clinical trial sponsor will cover the cost of the therapy being tested.
- Both eyes were injected at the same time. Most clinical trials would only treat one eye at a time and allow up to 30 days between patients to ensure the approach was safe.
- Even though the treatment was listed on the clinicaltrials.gov website, there is no evidence that this was part of a clinical trial, and certainly not one approved by the FDA.
Most importantly, patients should check with their doctor before considering any medical treatment or participating in any clinical trial. You can also find great information for patients considering stem cell treatments here that has been produced by the International Society for Stem Cell Research (ISSCR).