Three elderly women in Florida have been blinded by an unproven treatment, as a reminder of how dangerous stem cell therapies can be. The New England Journal of Medicine reports that the women signed up for a purported clinical trial in 2015 – for which they had to pay US$5,000. Within a week, they experienced a variety of complications, including vision loss, detached retinas and haemorrhage. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200. They are now blind.
The article is a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," said Jeffrey Goldberg, of Stanford University School of Medicine and a co-author.
"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," said Thomas Albini, another co-author.
At the clinic, U.S. Stem Cell Inc, fat cells from the patients’ abdomens were processed to obtain stem cells which were injected into their eyes. Patients reported that the entire process took less than an hour. The patients had both eyes treated at once -- even though most doctors would opt for a conservative approach to observe how the first eye responds.
"There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but there's no excuse for not designing a trial properly and basing it on preclinical research," Goldberg said.
The "trial" lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said. "There was a whole list of egregious things," Albini said.
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