When doctors give their patients a difficult diagnosis, whether it’s for a condition like cancer or a rarer disease for which there is no standard treatment, they often refer them to clinicaltrials.gov. The National Institutes of Health and National Library of Medicine provide this web site as a service for people who want to find and participate in trials of experimental treatments. With so many new studies launched every day of promising therapies, it is a helpful resource for both doctors and patients eager to do everything they can to beat their disease.
But a report published in the New England Journal of Medicine highlights the dangers of some experimental trials, even ones listed on a government-supported site. Three women in their 70s and 80s who enrolled in a stem cell trial to treat age-related macular degeneration, caused by deterioration of the most sensitive part of the retina, were left with severe vision loss following the treatment they received in the trial. All three patients found the study, sponsored by BioHeart, Inc., on clinicaltrials.gov.
The women each had liposuction to remove fat tissue, and the fat cells were processed to extract stem cells that they were told would develop into cells that would replace the diseased ones in their eyes.
Instead, the injected solution caused inflammation, infection and detached retinas in all three women. Detached retinas require surgery to repair in order to prevent blindness. Within days of receiving the treatment, all three patients went to the hospital with vision loss, severe infections and bleeding.