Ajay E. Kuriyan, MD
Assistant Professor of Ophthalmology
Flaum Eye Institute
University of Rochester Medical Center
I had the privilege of presenting the complications and blinding outcomes of three patients who underwent bilateral intravitreal “stem cell” injections at a “stem cell” clinic at the Retina Society 2017 meeting. The patients’ visual acuity in their better-seeing eye ranged from 20/30 to 20/50 prior to the intravitreal injections. After one year, the patients’ visual acuity in their better-seeing eye ranged from 20/200 to NLP. The patients developed acute angle closure glaucoma (2 or 6 eyes), lens subluxation (5 of 6 eyes), intraretinal hemorrhages (4 of 6 eyes), and retinal detachment with severe proliferative vitreoretinopathy (5 of 6 eyes). The patients paid $5,000 for the procedure and the injections were performed by a nurse practitioner.
Prior to taking care of these patients, I had heard of complications after treatments at foreign “stem cell” clinics for non-ocular diseases. However, I was not aware of the scope of the problem in the United States (U.S.). The U.S. has the largest number of “stem cell” clinic websites in the world: 187 websites offering treatments at 215 clinics. These clinics offer costly, unproven and unregulated “stem cell” therapies for a variety of disorders, charging up to $50,000 for the procedures. Since publishing the three cases described above, I have learned about several other similar cases occurring at different “stem cell” clinics.
The Retina Society 2017 meeting highlighted the tremendous progress made over the last 50 years in the field of retina (Historic Symposium link). Several presenters spoke about the potential of cell therapy for retinal diseases. It is with great hope that I look forward to the results of future legitimate cell therapy clinical trials. These predatory “stem cell” clinics exploit the same hope that patients have about cell therapy. The “stem cell” clinic that performed the bilateral intravitreal injections had a study examining intravitreal stem cell injections for dry AMD listed on Clincialtrials.gov. Although none of the patients were enrolled in the study, the listing of the study on Clinicaltrials.gov may have led the patients to have a false sense of trust in the “stem cell” clinic.
The American Academy of Ophthalmology issued a clinical statement in 2016 which highlighted the “stem cell” clinic issue and emphasized that the risks of these “stem cell” treatments is still unknown. The Clinicaltrials.gov website has added a statement on its homepage reinforcing that it is simply a registry of clinical trials and encouraging patients to speak with a “trusted healthcare professional” prior to enrolling in a study. The FDA has also recently issued a warning letter to the “stem cell” clinic that performed the procedure in the three patients for marketing stem cell products without FDA approval and for deviations from good manufacturing practices.
It is imperative that we continue to disseminate this information to our patients and explain the difference between actual stem cell research and the activities carried out at “stem cell” clinics. Further regulation of these “stem cell” clinics is also necessary to help prevent similar catastrophic visual outcomes in patients and an erosion in trust in legitimate stem cell research.