A team of ophthalmologists says the amount of harm being done by unapproved stem cell therapy is underreported.
The team went looking for scientific evidence in support of commercially available “cell therapy” for eye diseases after one of the ophthalmologists lost the battle to save a woman’s sight after undergoing an unapproved treatment for macular degeneration. Not only did they find virtually none; they instead discovered a growing number of patients are being irreparably harmed by unapproved cell therapies.
The ophthalmologists leading the study, Drs Ajay Kuriyan and Andrew Chen, and colleagues at the University of Rochester’s Flaum Eye Institute and the University of Miami’s Bascom Palmer Eye Institute reviewed evidence supporting cell therapy published in scientific journals and from the clinics’ websites and marketing materials. Their review of published studies found only a few case studies, involving a total of 18 patients. All patients were reported to have had positive treatment outcomes or no improvement. However, the researchers were able to identify at least seven patients who had experienced devastating harm from an unapproved cell therapy.
The number of clinics administering stem cell therapies not authorised by the Federal Drug Administration (FDA) has proliferated in recent years, with nearly 600 clinics opening in the United States alone. The clinics claim to help patients suffering from a broad range of conditions including age-related macular degeneration, Parkinson’s disease, autism and multiple sclerosis.
In May, the FDA began cracking down on clinics marketing unapproved therapies after three women with macular degeneration lost their vision after undergoing an unproven stem-cell treatment at a Florida clinic.
