Patients Lose Sight After Stem Cells Are Injected Into Their Eyes

The left eye of a patient showing hemorrhages 13 days after stem-cell injection. CreditDr. Thomas Albini

Three women suffered severe, permanent eye damage after stem cells were injected into their eyes, in an unproven treatment at a loosely regulated clinic in Florida, doctors reported in an article published Wednesday in The New England Journal of Medicine.

One, 72, went completely blind from the injections, and the others, 78 and 88, lost much of their eyesight. Before the procedure, all had some visual impairment but could see well enough to drive.

The cases expose gaps in the ability of government health agencies to protect consumers from unproven treatments offered by entrepreneurs who promote the supposed healing power of stem cells.

The women had macular degeneration, an eye disease that causes vision loss, and they paid $5,000 each to receive stem-cell injections in 2015 at a private clinic in Sunrise, Fla. The clinic was part of a company then called Bioheart, now called U.S. Stem Cell. Staff members there used liposuction to suck fat out of the women’s bellies, and then extracted stem cells from the fat to inject into the women’s eyes.

The disastrous results were described in detail in the journal article, by doctors who were not connected to U.S. Stem Cell and treated the patients within days of the injections. An accompanying article by scientists from the Food and Drug Administration warned that stem cells from fat “are being used in practice on the basis of minimal clinical evidence of safety or efficacy, sometimes with the claims that they constitute revolutionary treatments for various conditions.”

Kristin C. Comella, the chief science officer of U.S. Stem Cell, said in an interview that the clinic did not need F.D.A. approval because it was treating patients with their own cells, which are not a drug. She said the stem-cell treatments were comparable to patients’ receiving grafts of their own skin — a procedure not a drug.

Two of the eye patients sued the clinic and settled, but it has faced no other penalties. Ms. Comella said it no longer treats eyes, but continues to treat five to 20 patients a week for other problems like torn knee cartilage and degenerating spinal discs.

All three women found U.S. Stem Cell because it had listed a study on a government website, clinicaltrials.gov — provided by the National Institutes of Health. Two later told doctors they thought they were participating in government-approved research. But no study ever took place, and the proposed study on the site had no government endorsement. Clinical trials do not need government approval to be listed on the website.

Legitimate research rarely, if ever, charges patients to participate, scientists say, so the fees should have been a red flag. But many people do not know that.

Promising stem-cell research in eye disease and other conditions is taking place. But researchers and health officials have been warning for years that patients are at risk from hundreds of private clinics that have sprung up around the United States and overseas, offering stem-cell treatments for all manner of ailments, like injured knees, damaged spinal discs, neurological diseases and heart failure. Businesses promising “regenerative medicine” have multiplied, with little or no regulation.