A 77-year-old woman with exudative macular degeneration underwent bilateral intravitreal injections of “stem cells” at a clinic in Georgia. One month and 3 months after injection, she developed retinal detachments in the left and right eyes, respectively. Increased awareness within the medical community of such poor outcomes is critical so that clinics offering untested practices that have been shown to be potentially harmful to patients can be identified and brought under U.S. Food and Drug Administration oversight.
Enthusiasm for stem cell treatment has given rise to numerous clinics in the United States offering unproven “stem cell” therapies without the oversight of the U.S. Food and Drug Administration (FDA). Though current FDA-regulated clinical trials are ongoing to evaluate the use of stem cell technology, unproven and unregulated “stem cell” therapies are already being offered to patients in hundreds of clinics in the United States. In June 2016, the American Academy of Ophthalmology published a clinical statement warning that unproven “stem cell” therapies “require further scientific evaluation to assure their safety and effectiveness to the public in well-conducted clinical trials under the aegis of the FDA.”1 Here, we describe a case of delayed retinal detachment with poor visual acuity and anatomical outcomes following bilateral intravitreal injection of autologous adipose tissue-derived “stem cell” therapy in a clinic in Georgia performed without FDA oversight.Page