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Eyes Wide Open: Stem Cell Therapy Patients Confront Promise, and Peril

SriniVas Sadda, MD

President & Chief Scientific Officer

I want to share a few thoughts regarding the recent stories about three elderly patients in Florida who hoped to slow the decline of their vision due to macular degeneration by opting for stem cell injections to the eye. Instead of enjoying restored vision, they wound up blind. The doctors offering the treatment believed that because the stem cells were harvested from the patients’ own bodies, (using liposuction) the treatments were exempt from FDA approval or other regulations regarding the use of stem cell therapies. Unfortunately, the results were devastating.

If you are considering stem cell therapy, the short answer is: at this time, in the U.S., the only legitimate retinal stem cell therapy protocols are trials being conducted with oversight from the FDA and after careful review by an independent Institutional Review Board (IRB). You can go to the National Institutes of Health clinicaltrials.gov website to read about the trial. But this listing is not evidence that the trial has been endorsed by the government or by the FDA. You need to confirm with your doctor that the trial has been approved by an experienced IRB. You should also carefully review all of the risks and benefits described in the written informed consent form. Legitimate clinical trials rarely charge patients to participate in the study. If you are being charged, be wary. In addition, I personally would never participate in a study where both eyes are being treated by an experimental therapy at the same time. Any of these should be warning signs to you that the experimental procedures have not been vetted carefully.
I’ve written here before about Doheny’s work in the area of adult stem cell research. We are encouraged by the early findings, and we continue to collaborate with our colleagues around the globe to find the best approaches and applications. We are committed to ensuring that we proceed in a careful and meticulous fashion, making sure that all risks and safety concerns are addressed.

We are engaged in this research because we are always searching for the treatments that will work. Yet, even when we have proven approaches, it is impossible to predict the precise outcome of any medical procedure, because every case is different, as every individual is unique.

What we do know is that the best Rx for vision loss is always some combination of what Doheny has to offer every patient—excellent doctors + top notch technology + superior science + hope. I understand how important hope is. We at Doheny hope along with our patients. And, rigorous science and continuous institutional review is the foundation of all that we do. When considering any experimental therapies, don’t be shy about exercising due diligence to make sure the procedure you are considering has been carefully reviewed by the FDA and by an IRB.

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