Researchers warn of “devastating” consequences from unapproved stem cell therapy

US clinics that claim to offer treatment for blinding eye disease using cell therapy are under-reporting serious complications, scientists caution


Scientists have warned of the dangers of using unapproved stem cell therapy by identifying at least seven patients who experienced “devastating” harm as a result of the intervention.

Presenting their findings at the American Academy of Ophthalmology annual meeting (27–30 October, Chicago), the researchers highlighted that there are close to 600 clinics in the US offering stem cell therapies that have not been approved by the Food and Drug Administration (FDA).

Eye conditions that the clinics claim to treat include age-related macular degeneration, serpiginous choroidopathy, Leber hereditary optic neuropathy and nonarteritic ischemic optic neuropathy.

In May, the FDA began restricting clinics marketing unapproved therapies after three women in Florida with macular degeneration lost their vision from an experimental stem cell treatment.

Researchers from the University of Rochester and University of Miami found that many unapproved clinics omit adverse results from their reported data.

Dr Ajay Kuriyan, from the University of Rochester, said that his research team were able to identify at least seven patients who suffered “disastrous” outcomes from unapproved stem cell therapy.

“When you look at these company’s websites and their publications, you’ll see a big under-reporting of profound complications. There’s a fairly significant number of patients who experienced poor or in some cases devastating results,” he elaborated.

To help patients identify legitimate clinical trials, the ophthalmologist advised against joining studies that require payment.