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Hundreds of clinics in US offering stem cell therapies without FDA approval

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Ajay E. Kuriyan

VANCOUVER, British Columbia — A cross-sectional, clinical study of stem cell therapy clinics found 40 companies with 76 clinics across the United States offering patients non-FDA approved “cell therapy” for ocular conditions, according to a speaker here.

“There is a large number of cell therapy clinics across the United States working on providing direct to consumer marketing. They offer treatment for a variety of retinal conditions and the cells are harvested from different sources and administered in various different routes. It’s very important to continue to educate patients about the potential risks of treatments at such stem cell clinics,” Ajay E. Kuriyan, MD, said at the American Society of Retina Specialists meeting.

The researchers found 187 websites offering non-FDA approved stem cell interventions at 215 different clinics across the United States. The fee for treatment injections ranged from $5,000 to $50,000.

The cross-sectional, clinical study used systematic, keyword-based internet searches, and websites were data-mined for content analysis.

Of the 76 clinics offering stem-cell treatments for ocular conditions, the most common marketed treatment was “macular degeneration” with 35 clinics offering treatment.

“The most common were macular degeneration, retinitis pigmentosa, diabetic retinopathy, and retinal detachment. Some of the websites were very vague, including ‘ophthalmology’ as a condition they treated,” he said.

The common source of the “cell therapy” advertised by the clinics was “autologous adipose-derived stem cells,” with 67% of the clinics offering that therapy. Thirty-two clinics offered single “cell” source types and eight companies offered multiple “cell” types, Kuriyan said.

Eye injections, intravitreal injections and retrobulbar injections were the three most used routes of “cell therapy” administration, he said. – by Robert Linnehan

Reference: Kuriyan AE. Direct-to-consumer marketing by U.S. “cell therapy” clinics for retinal conditions. Presented at: American Society of Retina Specialists annual meeting; July 20-25, 2018; Vancouver.

Disclosure: Kuriyan reports no relevant financial disclosures.