A new report published by the New England Journal of Medicine details that three women have become permanently blinded after undergoing stem cell injections into their eyes at a Florida clinic. The three subjects were suffering from macular degeneration, an age-related eye disease that leads to vision impairment, and were under the impression that they were participating in a clinical trial for treatment of the disorder. In reality, these women had undergone the procedure at an unregulated Florida clinic called US Stem Cell, where staffers extracted stem cells from the women’s belly fat via liposuction and then injected them into the eyes.
Stem cell treatments, although buzzy (you’ve heard about them in the context of being able to treat a myriad of disorders and even incorporated into skin care products) are largely unregulated, making it difficult for consumers to differentiate between solid medical research versus marketing hype. While there is plenty of legitimate research being done in the space—some very promising—therapy centers that lack safety standards or sufficient medical knowledge are commonplace.
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According to Westchester, NY, oculoplastic surgeon James Gordon, MD, stem cell injections could potentially offer ocular benefits including treatment for corneal disease and optic nerve problems, but isn’t considered the most conventional approach for treating common eye disorders. “Macular degeneration is usually a slowly progressive disorder,” he says. “The disease progress can be slowed down further with intake of antioxidant vitamins, sunglasses and green leafy vegetables, and in more severe cases, by injecting certain medications directly into the eye.”
Montclair, NJ, plastic surgeon Vincent Giampapa, MD, says that there are some promising uses for stem cell treatments with a track record of good results and years of research behind them, but the use of stem cell treatments for macular denegation is still “very new and experimental at the moment.”
To date, there is only one FDA-approved stem cell product, which is used to treat specific blood disorders and the agency advises those considering stem cell treatment for other uses to only participate in FDA-regulated clinical studies.
“If patients want to consider stem cell therapy for a disease, they should go to ClinicalTrials.gov and look for specific trials that are approved by the government with an IRB (independent review/ethics board) study,” says Dr. Giampapa. “This is the only legitimate way to find a study that is being run in an approved fashion and with the appropriate safety factors in place.”
“When patients are considering an unconventional approach to treating a medical condition they should first investigate approved treatment options. If none of these seem particularly promising, then it's reasonable to explore other alternatives,” adds Dr. Gordon. “The credentials of the doctors involved need to be known. Previous results and complications of the treatment need to be carefully reviewed. Potential risks are very important to consider. When the risks of poor outcomes outweighs the potential benefits, the patient might be wise not to pursue the treatment. Second and third opinions from physicians not involved should be sought.”