Three Women Blinded in Unproven Stem Cell Treatment

Medical trials involving stem cells, specifically those asking for money can be dangerous. The New England Journal of Medicine will be publishing an article about a trial that was done in Florida that left 3 subjects blinded. The article is an attempt to make regulatory agencies, doctors and patients aware of the dangers of patient funded, minimally regulated research. The patients involved in this trial paid 5,000 dollars each to participate.

This particular trial took place in 2015, stem cells were injected into the intravitreal to treat dry macular degeneration. The website for the trial states that it was being monitored by the U.S. National Library of Medicine, a group that is supposed to be monitored by the NIH. The three women, who were suffering from dry macular degeneration, had fat cells removed from their abdomens and stem cells were extracted. The cells were mixed with platelet dense plasma drawn from each patient and injected into their eyes. The cause of the blindness could have been contamination in the injections or scar tissue formed but experts believe the blindness is permanent.

There were red flags before this trial started, the most obvious being not a lot of information on the trial’s website. The trial was not FDA approved or regulated. People who want to participate in stem cell trials should check out trusted websites for stem cell trials as well as researching that the trial is being done at an accredited academic affiliated clinic.

Key Points:

  • 1Three women were blinded in a clinical trial that involved injections of stem cells into their eyes to treat dry macular degeneration.
  • 2Warning signs that the clinical trial was suspect include lack of information about the trial, having the test subjects pay for treatment, and that the surgeon treated both eyes.
  • 3The clinic that performed the procedure is still seeing patients, but no longer performing the eye injections that caused blindness in the three women.

Researchers warn people to be careful of stem cell clinical trials that aren’t properly run or ask patients for payments.

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