Three women with macular degeneration who thought they were taking part in a clinical trial against this progressive and irreversible loss of vision, became blind after this unapproved therapy, according to a report from the American medical journal.
In addition to loss of vision, patients aged 72-88 suffered retinal detachment and hemorrhage, and shortly after this procedure was performed in an unidentified clinic in Florida.
They believed they were participating in a legitimate clinical trial on a National Institute of Health (NIH) website, according to an article in The New England Journal of Medicine . This is ClinicalTrials.gov, where all current studies are listed for information purposes.
This article is “a call to raise awareness among patients, the medical community and federal regulatory agencies about the risks of this type of uncontrolled and patient-funded research,” in this case stem cell therapy, “Says Dr. Jeffrey Goldberg, a professor of ophthalmology at the Stanford Medical School.
“Stem cells are raising great hopes and these types of clinics attract desperate patients who think that such therapy will cure them but in this case these women have experienced a dangerous and out-of-the-ordinary clinical experience,” adds Dr. Thomas Albini, Professor of Clinical Ophthalmology at the University of Miami.
Each of the three patients paid $ 5,000 for the intervention.
However, any paid clinical trial should put the chip in the ear, say the authors, who explain that serious studies are never financed by the patients.
The preparation of poor quality stem cells for injection into the eyes of these women could explain the complications, they say, citing possible contamination of the solution to purify them.
And even if the interventions were done well, they say, there is no evidence that they could have restored the patients’ vision.
There are, in fact, very few indications that this type of stem cells, taken from the fat of the abdomen, have the capacity to become cells of pigmented retinal epithelium.
Another fact unusual, Professors Goldberg and Albini argue, was performed in both eyes of the patients, while doctors always choose caution in this type of experimental therapy.