Three women who paid thousands of dollars to participate in a clinical trial of a supposed “stem cell therapy” in the United States became blind as a result of the experiment, reports an article published in the journal New England Journal of Medicine (NEJM).
According to a note on the article released by the Stanford University Medical Center, where one of the co-authors teaches, the three patients, aged 72 to 88, suffered from macular degeneration. Before the treatment they still had some vision, but after the surgery to implant the experimental stem cells they were blind and had almost no chance of recovery, says one of the authors of the article in NEJM, Thomas Albini, professor of ophthalmology at the University of Miami, who treated two of the victims.
The study in which the women participated was registered as “evaluating the safety and effects of cells injected intravitrally in dry macular degeneration”, and the patients believed they were participating in a legitimate clinical trial, although, according to the article signed by Albini, Jeffrey Goldberg , from Stanford, and Ajay Kuriyan, from the University of Rochester Medical Center, the permission slips they signed weren't really clear about this. Each paid US$5 for the procedure.
“There is a lot of hope in stem cells, and there are clinics that appeal to desperate patients (.,..) but in this case the women participated in a clinical initiative that was incredibly dangerous,” said Albini, in a note, adding that tests Those who ask for money from participants should be viewed with suspicion.
The procedure, as described in NEJM, involved removing fat cells from patients' abdomens, as well as blood samples. The fat was then treated with enzymes, supposedly to generate stem cells, and the cells were then mixed with plasma extracted from the blood. The mixture was injected into both patients' eyes at the same time, another sign of danger and lack of control in the experiment, according to the authors.
The clinic, which is not identified in the “paper”, appears to have benefited from loopholes in the American regulation of clinical trials, which until October 2015 was more lenient with experiments involving cells originating in the patient's own body and “minimally processed”.
Reference:
Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD
[N Engl J Med 2017; 376:1047-1053 March 16, 2017 DOI: 10.1056/NEJMoa1609583]
