And there are likely even more cases. Since writing the first report, says Ajay Kuriyan, an author on the report and now a retinal specialist at the University of Rochester, eye doctors around the country have come forward with similar stories of stem-cell injections gone awry. They are now preparing an article describing the additional cases.
* * *
Stem-cell clinics that offer seeming miracle cures for everything from back pain to erectile dysfunction have proliferated in the United States in the past decade. These cases of blindness now cropping up in the medical literature point to the potential dangers of letting hundreds of such clinics operate without oversight.
In August, the FDA moved toward a crackdown. It posted a warning letter to the Florida clinic that had treated the first three women and called the fat-derived stem cells an unapproved treatment. On the same day, the agency announced that federal marshals had seized live-virus vaccines from a California company that was injecting the viruses along with stem cells into cancer patients. After the news broke, says Mark Berman, a plastic surgeon and the California company’s director of stem-cell implantation,“I’ve actually had patients call me up, cancel their surgery, demand their money back, and tell me what a disgusting human being I am and I should be removed from this planet.” He criticized the initial news reports as “classic leftist kind of propaganda, fake news.”
Berman also cofounded the Cell Surgical Network, of which the Georgia clinic that treated the 77-year-old woman is an affiliate. The network trains affiliated doctors to use their equipment and follow their stem-cell therapy protocols.
The case report does not name the Georgia clinic, but The Atlantic has independently confirmed it is the Stem Cell Center of Georgia, which operates within the Ageless Wellness Center in Peachtree City. The clinic declined to comment for this story. A local news report from June 2016 quotes the center’s doctor as saying, “We have an ophthalmologist who is going to treat three people with macular degeneration with intraocular injections.”
Berman says that his network’s affiliates have performed about 15 eye procedures total. They stopped offering it after the woman went blind. (Cell Surgical Network and the Stem Cell Center of Georgia both still list macular degeneration on their websites.) The injections, he says, were part of a study approved by an institutional review board. At the clinic, the 77-year-old woman received injections into her two eyes one day apart. Berman concedes that they should have waited longer to make sure there were no serious side effects after the first eye. “That’s a pretty good lesson learned. Unfortunately it was learned by doing them,” he says.
Others say the clinic should have known better. “It’s just not a professional thing to take an unproven intervention and inject it in both eyes,” says Leigh Turner, a bioethicist at the University of Minnesota, who tracks stem-cell clinics. Kuriyan says that injecting both eyes and asking patients to pay out of pocket for their treatment are both highly unusual for clinical trials. “Those are all big red flags,” he says. A better approach, he says, would have been to test the injections in animals for safety first.