An experimental stem cell treatment made 3 patients blind. They hoped they could be cured of AMD.
They hoped to cure their age-related macular degeneration (AMD). They eventually lost their sight. Three women were victims of an unscrupulous clinic in Florida (United States). Under the guise of a clinical trial, the establishment offered them experimental treatment, based on stem cells, for this eye disease.
In reality, the experiment was absolutely not authorized by the health authorities, indicates Stanford University (United States). She returns, in the New England Journal of Medicine, on this almost perfect scam.
A cleverly crafted deception
All the elements were in place to mislead the three women who volunteered. In 2015, the Bioheart Clinic – since renamed US Stem Cell Inc. – launched a “study to assess the safety and effect of cells by intravitreal injection in dry macular degeneration.” Nowhere is the term clinical trial mentioned. No more in the documents signed by the three patients, aged 72 to 88.
The deception is in fact skillfully worked. Description of the experience is posted on a government site that lists clinical trials. This involves transforming fat cells into stem cells before injecting them into patients’ eyes, and then observing the results. The transplant is said to be autologous because it relies on the cells of the patients themselves.
First element of suspicion: the clinic chooses to perform the injections in both eyes at the same time. Prudence would have liked it to treat only one eye. Because in the week following the treatment, the three women develop complications. Retinal detachment, loss of vision, hemorrhage… the situation quickly escalates. Today, all three are blind and risk remaining blind for life.
A test not at all controlled
The possible causes for such complications are multiple: the preparation itself, the injection of a contaminant, the composition of the solution for washing the eyes … Stanford researchers even estimate that the stem cells have transformed into myofibroblasts, responsible for scars. In fact, even if the transplant had been performed correctly, there is no guarantee that the procedure would have worked.
The literature is quite cautious about the efficacy of stem cells derived from adipose tissue. Moreover, the sites working on this subject make it clear: “stem cell therapy is not approved by the FDA (American Food and Drug Administration, editor’s note) and does not constitute treatment for any pathology ”.
“There is a lot of solid evidence of the potential of cell therapy for many human diseases, but this is no reason to badly organize a clinical trial and rely on preclinical research”, plague Jeffrey Goldberg, also author of the NEJM article. In short, almost all the essential elements of a clinical trial worthy of the name were missing: preliminary laboratory experiments, control group, data collection, anonymity, patient follow-up … The procedures were not even approved by the FDA, because the stem cells were autologous and very little processed… in accordance with the rules, which have since been revised.
$ 5,000 per volunteer
“A lot of hopes are heightened by stem cells, and this type of clinic is aimed at desperate patients, awaiting treatment, who hope that this will be the solution”, underlines Thomas Albini. Bioheart is not the only establishment to bear fruit on the hopes of patients. According to the agency Reuters, some 600 American clinics claim to carry out experiments of this type.
This estimate is taken from an assessment published in June 2016, in Cell Stem Cell. She points out that the industrialist’s approach to the patient has many flaws. Starting with that the effectiveness of stem cells has not been demonstrated.
This type of incident should cause “an awareness for patients, doctors and health authorities on the risks of this type of study, funded by the patient and very little regulated”, according to Jeffrey Goldberg. Indeed, each patient had to pay 5,000 dollars (4,650 euros) for the procedure. No clinical trial requires volunteers to pay any fees to be included. In these unscrupulous institutes, organizers can claim up to $ 50,000.
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