Stem cell clinic masquerading as legit research blinds three in Florida

Ars has reported before about the predatory ways of direct-to-consumer clinics touting unproven and sometimes dangerous stem cell therapies. As these clinics bubble up around the country, their slimy ads targeting desperate patient populations may seem pretty low. But a stem cell company in Florida may have them beat in the despicable category: it posed as a legitimate research clinic conducting a trial listed on the government registry, clinicaltrials.gov.

The result: three women permanently lost their vision after seeing the listing and signing up—and paying thousands of dollars, of course.

In a report published Wednesday in the New England Journal of Medicine, doctors and researchers report in detail the medical aftermath for the three patients, who were all seeking treatment for age-related macular degeneration. This is a common disease that diminishes eyesight slowly over time and does not, by itself, lead to blindness. Two of the patients have already sued the company behind the clinic, US Stem Cell (previously known as Bioheart, Inc.). The suit was settled, and the patients signed nondisclosure agreements.

The clinical trial, which the three women were never actually enrolled in, never took place and has been withdrawn. The trial was said to have been approved by an institutional review board, a necessary step for trials. But there were no details about the approval or the board.

US Stem Cell would not answer Ars’ questions, but in an e-mailed statement said:

Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01 percent adverse reactions reported. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations. Neither US Stem Cell nor US Stem Cell Clinic currently treats eye patients.

According to the authors of the NEJM report, led by ophthalmologists at the University of Miami, the company should never have tried to treat eyes. In the article, they describe how the clinic used liposuction to collect fat cells from the women’s abdomens and treated the cells with enzymes to try to induce them to revert to stem cells. Then, the cells were mixed with platelet-rich plasma, also taken from the patients, and injected directly 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.