Doctors say unproven stem cell treatment blinded three women

NEW YORK Three women were left nearly or totally blind by a vision treatment at a stem cell clinic, in what doctors call a dramatic illustration of how risky such clinics can be.

The clinic’s method hasn’t been proven effective or tested for safety in people, said ophthalmologist Dr. Thomas Albini of the University of Miami. He and colleagues, who examined the women after their treatments at a Florida clinic, described the outcome in Thursday’s New England Journal of Medicine.

“These women had fairly functional vision prior to the procedure ... and were blinded by the next day,” Albini said in an interview.

One woman is totally blind and the others legally blind, and it’s very unlikely their vision will improve, he said.

Scientists have long studied the use of stem cells, including those taken from a patient’s own body, for treating vision problems and a variety of other diseases. But they and regulators have also issued warnings about clinics that offer unproven stem cell therapies.

The new report says the three women, in their 70s and 80s, paid $5,000 to be treated in 2015 for age-related macular degeneration. A leading cause of vision loss in people older than 50, the condition damages a part of the retina needed for sharp, central vision.

At least two of the women had gone to the clinic because it listed a macular degeneration study on a federal database, Albini said. The clinic later withdrew the listing before recruiting any patients to participate. The consent form one woman showed Albini’s group was simply for a medical procedure not a study, he said.

Each woman was injected in both eyes with a cell preparation derived from her own fat tissue.

“It’s very alarming to us as clinicians that somebody would do this to both eyes at the same time,” said Albini.

He said all suffered detached retinas.

The clinic is operated by U.S. Stem Cell, Inc. It offers stem cell treatments for a variety of diseases and injuries, according to the company’s website. In a statement Tuesday, the Sunrise, Floridabased company said it does not currently treat eye patients. The company said it could not comment on specific cases, but that its clinics “have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported.”