We have reported a lot on the amazing possibilities that stem cell treatment offer the rare disease community.
But something we assume, though we don’t hear much about, is that stem cell therapy doesn’t always work. Like in this case, of three women who entered a clinical trial for stem cell therapy treatment for age-related macular degeneration.
In short, this clinical trial, sponsored by U.S. Stem Cell, formerly Bio Heart, Inc., had some considerable peculiarities:
- The women paid $5,000 each to participate in the trial. Usually, treatment and costs incurred by the patient are covered, so actually paying to participate in the clinical trial is pretty weird.
- The women were treated in both eyes, simultaneously, with a treatment that was previously untested. Usually, researchers will test in one eye at first, just in case there are adverse reactions.
- The women cannot recall signing anything other than a surgical consent form. There is usually a clinical trial consent form, that at least addresses possible risks to the procedure.
It’s worth it to note, these clinical trials were posted on clinicaltrials.gov, a service provided by the NIH. While the NIH doesn’t endorse every individual clinical trial listed, I am sure there is a perceived level of reassurance of the legitimacy of the clinical trial, if it is listed here. But unfortunately, it’s up to the patient to verify the legitimacy of the trial.
But a recent move by the FDA goes beyond clinical trials and focuses on deceptive stem cell treatment centers.
The FDA actually sent a warning letter to the sponsors of the above mentioned clinical trial, U.S. Stem Cell, in Florida. They basically said, “you probably shouldn’t be marketing stem cell products without our approval”. The goal of this crackdown is to prevent the administration of possibly harmful, and unapproved treatment to desperate patients. In a way, they are trying to prevent patients from being taken advantage of with empty promises of cures.
But, representatives from some of the clinics they are cracking down on have denounced these moves, claiming that it’s preventing the field from moving forward. With that said, other stem cell researchers like George Daly, Dean of Harvard Medical School, have applauded the FDA. To read more on NPR, click here.
