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SAN FRANCISCO (PNA/Xinhua) – An ophthalmologist in the United States calls for increased patient education and regulation after three patients were blinded following a treatment marketed as a stem cell clinical trial.
A recent paper documenting the cases was co-authored by Jeffrey Goldberg, professor and chair of ophthalmology at the Stanford University School of Medicine, and published in The New England Journal of Medicine, a publication of the Massachusetts Medical Society as one of the most prestigious peer-reviewed medical journals in the world.
The three patients are all women, ranging in age from 72 to 88. They suffered from macular degeneration, a common, progressive disease of the retina that leads to loss of vision. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200, meaning they can read at 20 feet, or about 6 meters, a letter that people with “normal” vision can read from 30 to 200 feet, or about 9 meters to 60 meters.
Now, the patients are likely to remain blind, said co-author Thomas Albini, an associate professor of clinical ophthalmology at the University of Miami, where two of the patients were treated for complications from the stem cell treatments.
Two of the patients learned of the so-called clinical trial on ClinicalTrials.gov, a registry and results database run by the U.S. National Library of Medicine, where it was called “Study to assess the safety and effects of cells injected intravitreal in dry macular degeneration.”
Each patient paid 5,000 U.S. dollars for the procedure. Any clinical trial that has a fee should raise a red flag, said the authors, with Albini adding “I’m not aware of any legitimate research, at least in ophthalmology, that is patient-funded.”
At the clinic in Florida, which is not named in the paper, the patients had fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said.