Three blinded after dubious stem cell treatment injected into their eyeballs
Three blinded after dubious stem cell treatment injected into their eyeballs

          
          
There’s no evidence that any stem cell treatment can successfully reverse age-related macular degeneration (although there is legitimate research looking into it). And the use of fat cell-derived stem cells for treatments in general is also dubious. These types of stem cells are becoming trendy in shady stem cell clinics, likely because they’re easy to get. But there’s little evidence that they work or are safe. There’s not even hard evidence that these types of stem cells can differentiate into cells found in the eyes, the authors note.
Yet, because the cells come directly from individual patients, they aren't regulated by the Food and Drug Administration. This allowed US Stem Cell to register its “trial” on clinicaltrials.gov without FDA approval.
The results for the patients were dramatic and devastating. One woman, aged 72, went completely blind. Before the treatment, she scored 20/30 vision with one eye and 20/60 with the other. The other two, aged 78 and 88, lost nearly all of their vision. They all suffered detached retinas and other damage.
Each of the women said they paid $5,000 for the procedure.
Researchers, doctors, and the FDA generally recommend against ever going to non-academic stem cell clinics, which are poorly regulated, unsafe, and have little evidence for the effectiveness of their treatments. For anyone interested in signing up for a clinical trial, researchers recommend making sure that the trial is approved by the FDA and taking place in an academic or other reputable institution.
Also, look out for red flags. Legitimate clinical trials generally do not require you to pay for an experimental procedure. In fact, some compensate participants for their efforts and risks. Paperwork and consent forms should clearly indicate that you’re entering a trial. (Two of the women in this case thought they were in a trial but in fact never signed anything indicating an enrollment.) And be wary of odd procedures. In the case of the eye injections, the clinic injected both eyes at once, which is highly unusual and unsafe for an experimental treatment.

"The need for oversight of such clinics and for the education of patients by physicians and regulatory bodies is paramount to protecting patients while advancing proper research and innovation," the authors conclude.
New England Journal of Medicine, 2017. DOI: 10.1056/NEJMoa1609583  (About DOIs).



          
                  