Experts Warn Of Dubious Clinical Trials As Unproven Stem Cell Treatment Blinds 3 Patients With Macular Degeneration
Three women with macular degeneration, a common disease associated with ageing that threatens the eyesight, became blind after stem cells were injected into their eyes. The treatment was done in a loosely regulated clinic in Florida.
$5,000-Stem Cell Treatment For The Eyes
The patients paid $5,000 each so they can receive the stem cell injections at a private clinic, which is part of the company Bioheart, now known as U.S. Stem Cell.
The procedure involved using liposuction to suck fat from the women's bellies. Stem cells were then extracted from the fat and injected into their eyes.
The results were disastrous. The patients, whose cases were reported in The New England Journal of Medicine, experienced complications and are now blind.
"The patients' severe visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment, or lens dislocation. After 1 year, the patients' visual acuity ranged from 20/200 to no light perception," the report reads.
Patients Thought They Were Part Of A Government-Approved Clinical Trial
The women learned of the so-called clinical trial on ClinicalTrials.gov, a registry database that is run by the U.S. National Library of Medicine, but the consent form and other written materials for the experimental treatment made no mention of the trial.
Two of the patients later told the doctors that they thought they were participating in a research green-lighted by the government despite that no study took place and the proposed study on the site was not given government endorsement.
Ajay Kuriyan, from the University of Miami, where the patients were referred to after suffering from complications, said that it is difficult for patients to know if a stem cell therapy or a clinical trial is legitimate, noting that many clinics offering stem cell treatment treat their patients with little oversight and even without proof of efficacy.
Kuriyan and colleagues, however, identified some red flags for treatments claimed to be part of a clinical trial.
Red Flags To Watch Out For
The patients who were blinded by the procedure, for instance, were required to pay and that both of their eyes were treated at once.
Legitimate clinical trials do not ask for payment, and good doctors involved in any experimental treatment of the eyes would observe how one eye responds to the treatment first before making a second attempt on the second eye.
The authors likewise said that listings on ClinicalTrials.gov did not get full scrutiny for scientific soundness. Clinical trials neither need government approval to be listed on the website.
The Food and Drug Administration recommends that people who consider getting a stem cell treatment need to make sure it has been approved or is being studied in a clinical trial that federal health regulators have allowed.
"If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal," the FDA said.