As a result, three elderly women were robbed of their vision after undergoing a stem cell therapy for macular degeneration in 2015, offered by an un-named clinic in Florida, reported a recently published paper.
According to Dr Thomas Albini, from the University of Miami and co-author of the study, it is possible that the patients may remain virtually blind for good.
Patients thought they were participating in a clinical trialThe three women, within the age of 72 to 88, were under the impression that they were taking part in a clinical trial, according to the paper. The women had found out about the clinic’s work on the ClinicalTrials.gov database, which is run by the US National Library of Medicine.
Yet, according to one of the study’s authors, Dr Jeffrey Goldberg, chair of ophthalmology at the Stanford University School of Medicine, listings on ClinicalTrials.gov have not been vetted for scientific legitimacy nor patient safety.
Moreover, the consent form signed by patients prior to the treatment was in fact to give permission for the stem cell procedure and not for participation in a clinical trial, according to Albini.
Albini had treated two of the women a few days after their procedures. The women who initially had trouble reading small text were could barely see hand movements or light. They suffered pain, detached retinas and haemorrhages in their eyes.
The procedure cost USD $5,000 per patient, and involved using abdominal fat cells to create stem cells that are injected into the eyes. However, there was little evidence that the stem cells in the procedure could potentially treat macular degeneration.
"There is a lot of very well-founded evidence for the positive potential of stem therapy for human diseases, but there's no excuse for not designing a trial properly," said Goldberg.
FDA to tighten regulation on the use of stem cells in treatmentsThe "devastating outcomes" experienced by the women raise the "need for oversight of such clinics and for the education of patients by physicians and regulatory bodies," stated in the paper.
The US Food and Drug Administration (FDA) has come under fire for the lack of regulation of stem cell treatments. Clinics are not subject to regulation of procedures using stem cells taken from a patient’s own body provided they are “minimally processed.”
“There is little question that when the FDA is involved in regulatory oversight it works in favor of patient safety,” added Goldberg. “That would have protected patients in cases like these.”
"The inaction by the FDA not only puts many patients at serious risk from unproven stem cell offerings, but also it undermines the agency's credibility," Paul Knoepfler, a University of California stem cell researcher, wrote in an email.
An FDA spokeswoman wrote in an email that the agency is in the process of finalising four new guidelines to clarify the use of stem cells as treatments in clinics. The FDA also said that it had previously issued a warning to patients.
Patients need to learn how to identify legitimate procedures"Patients have to be wary and tell the difference between the snake oil salesmen who are going to exploit them and the kind of slow, painstaking legitimate clinical trials that are also going on," said George Daley, Harvard Medical School's dean and stem cell researcher, who penned the editorial accompanying the study.
Physicians should also take part in educating patients to be more aware of the legitimate stem cell treatments and verify beforehand that any procedure claiming to be a clinical trial is indeed affiliated with an academic medical centre. According to the paper, legitimate research is unlikely to be funded by patient fees.
As Albini warns, something that "sounds too good to be true may indeed be too good to be true and may even be horrible." MIMS
FDA puts leukaemia drug trial on hold after four patient deaths
China’s FDA says 80% of data from clinical trials in the country are ‘fabricated’
Hundreds of women died for the sake of research in cancer clinical trial