As we know science is a powerful weapon for the ease of our lives, but sometimes it could be disastrous. The same is happen in this case of an unproven stem cell therapy conducted by a Florida clinic has blinded three patients in an apparent clinical trial.They promised to cure three women’s retina disease but actually led them to blinding for the whole life.
As reported in the New England Journal of Medicine, the clinical trial involving three women between the ages of 72 and 88 came for the treatment of macular degeneration, a common progressive disease of the retina that leads to loss of vision.
None of the women were completely blind, but they were experiencing various degrees of vision loss when came for treatment from the Florida clinic.
The clinic claimed that a stem cell procedure would treat macular degeneration. But just after a week of injecting stem cells into their eyes in 2015, all three women became blind, and today after two years of efforts, doctors have concluded that there is no chance that their vision will ever be restored.
The authors of the new report, ophthalmologists Jeffrey Goldberg from Stanford University School of Medicine and Thomas Albini from the University of Miami, said the unfortunate incident serves as,
“A call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research.”
Stem cells are undifferentiated cells that haven’t quite decided what they want to be when they grow up. Under the right conditions, these immature cells can be transformed into virtually any kind of cell found in the body, which is why they’ve proven useful in regenerative medicine.
The problem is that there are nearly 600 clinics in the United States are working on unproven and unapproved stem-cell procedures for a wide range of conditions, such as arthritis, autism, muscular dystrophy, cerebral palsy, stroke and even cancer.
All these clinics have no monitoring or regulation from any government authority. Thus their results and procedures are always dubious and risky.
Two of the three patients were also misled by the information related to the stem cell trial for macular degeneration on ClinicalTrials.gov, which although is a registry run by the US National Library of Medicine
The NEJM study quotes the name of the trail as: “Study to assess the safety and effects of cells injected intravitreal in dry macular,” which when googled calls the trial up with the name of the company, Bioheart Inc. also known as US Stem Cell.
According to Goldberg and Albini, the trail center is no longer offering the procedure, but it is still seeing patients. The trial itself lacked all the components for a properly designed test, with no prior laboratory experiments, no control group, no data and no plans for follow-ups any follow ups.
At the time of the test, the procedure didn’t need FDA approval since the cells weren’t transferred between patients and they were considered “minimally processed.” Since then, the FDA has finally revised its requirements which mean these types of procedures will also require approval as the authorities look to clamp down on stem cell clinics.