Stem cell clinics around the country are offering experimental treatments to cure a myriad of ailments - from multiple sclerosis and paralysis to vision loss. However, these unproven treatments can cost patients thousands of dollars and potentially cause devastating side effects.
While serving as chief resident and co-director of Ocular Trauma at Bascom Palmer Eye Institute in Miami, FL, I was part of a team that took care of a patient who had blinding complications after receiving injections into her eyes at a stem cell clinic. She was charged $5,000 for the injection of stem cells that were isolated from her own body fat into both of her eyes, in hopes of halting the progressive vision loss caused by age-related macular degeneration.
Within days of the stem cell injections she was nearly blind and ultimately progressed to complete blindness. Two other patients who underwent similar treatments at the same clinic are also now legally blind after complications of the injections. Case studies of these three patients were published as a brief report today in the New England Journal of Medicine.
These patients provide an unfortunate example of what can go wrong when stem cell procedures are not appropriately regulated. Stem cell clinics have cropped up all over the US in recent years and are operating in a self-perceived regulatory loophole. They argue that deriving stem cells from a patient’s own body and minimizing manipulation of those cells should excuse them from the level of Food and Drug Administration (FDA) oversight used to vet traditional drugs.
The FDA, however, has stated that stem cells ought to be held to the same regulatory standard as any other drug, citing the complexity of mammalian cells, the manipulation needed to isolate stem cells, and the difficulty of predicting how these cells will react to different environments (i.e. different tissues of the body).
Without regulation of stem cell isolation and delivery processes at stem cell clinics, it’s hard to know whether their cocktails contain harmful chemicals leftover from the isolation process – or whether they contain stem cells at all. The stem cell clinic mentioned above committed a breach of standard clinical protocol by injecting an unproven experimental treatment into both eyes of a patient on the same day. Oversight from the FDA, would have prevented this.
The unregulated use of stem cells at these clinics is in stark contrast to the very responsible and appropriately regulated stem cell clinical trials being conducted at academic centers across the country. The actions of these stem cell clinics not only pose a risk to patients but also have the potential to erode trust in these legitimate stem cell studies. For patients, it’s hard to know the difference between a legitimate clinical trial and an unregulated experimental therapy that might put them at risk.
My best advice for all patients is to consult your physician about any experimental stem cell treatment that asks you to pay out-of-pocket; that is a huge red flag. Regulated clinical trials performed at academic medical centers are fully funded and do not require patients to pay for treatment.
In short, if you are asked to pay, walk away.
Ajay E. Kuriyan, M.D., M.S., is a retinal specialist certified by the American Board of Ophthalmology and an assistant professor of Ophthalmology at the University of Rochester Medical Center.