Title : Dozens of clinics market risky 'cell therapies' to treat eye disorders
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Dozens of clinics market risky 'cell therapies' to treat eye disorders
Scores of clinics across the United States directly advertise expensive — but unproven — cell therapy procedures to patients with serious eye diseases, often with devastating results, a new study warns.
Although there are no approved stem cell therapies to treat eye conditions in the U.S., when the authors of the study conducted a systematic internet search they found 40 companies with 76 clinics that advertised the procedures.
Desperate to save their vision, patients with conditions like macular degeneration and optic neuritis may respond to online advertisements from clinics across the country, often at tremendous personal cost, the researchers write in the journal Ophthalmology.
"None of this is covered by insurance. They're all paying out of pocket," coauthor Dr. Rajinder Nirwan of the Flaum Eye Institute at the University of Rochester Medical Center in New York told Reuters Health.
"Patients have paid anywhere from $5,000 US to upwards of $50,000 per treatment," he added. "Patients have been taking out mortgages on their homes to pay for these kinds of treatments."
California, Florida, and Illinois had the most clinics, according to the report. Sources of the stem cells included fat, bone, bone marrow, umbilical cord blood and placentas. Some companies infuse the cells through a vein; other companies inject them into the eye.
Complications can include bleeding in the eye and sudden, severe vision loss, Nirwan's team notes.
The researchers warn that cell therapy clinics often claim — incorrectly — that their services do not fall under FDA oversight. And because patient-funded trials of cell therapy for eye diseases may be listed on clinicaltrials.gov (the U.S. National Institutes of Health official online study registry), consumers may mistakenly take those listings as indications that the procedures have been vetted by regulators and the federal government.
"The proprietors have taken considerable pains to push the boundaries of the guidelines, and in some cases misrepresented registered studies as 'government approved' studies, thereby effectively gaming the system," said Dr. Henry Klassen, professor at the Gavin Herbert Eye Institute at the University of California, Irvine, who wasn't involved in the study.
Senior study author Dr. Ajay Kuriyan, also of the University of Rochester Medical Center, believes increasing patient awareness is the best path forward. He noted that most patients who opt for the treatments find them by looking for potential cures in Google searches.
"When you're searching online for other alternatives you do come across these very well designed websites and testimonials and videos that promise a lot, and I think it's easy when you have a disease that doesn't have a clear treatment option … that you try to look for other treatments," he said in a phone interview.
Klassen agrees that the clinic-seeking phenomenon is driven by desperation. "If validated medical options existed, there would be much less interest in non-validated procedures," he said.
Kuriyan is careful to clarify that cell therapies should not be broadly discounted as snake oil. "There are several studies happening … looking at stem cell therapy and I think we need to see what the [results] are," he said, adding that the safety and effectiveness need to be confirmed in legitimate clinical trials.
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