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Andrew Chen, Daniel Simhaee, Rajinder Singh Nirwan, Thomas A Albini, Jayanth Sridhar, Harry Flynn, Ajay E. Kuriyan; Assessing the level of evidence for the benefit of commercially-available “cell therapy” treatments in the U.S. for ocular diseases. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6400. doi: https://doi.org/.
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“Cell therapy” treatments, while non-FDA approved, are increasingly available to patients via online direct-to-consumer advertising for a variety of ophthalmic diseases. Few evidence-based studies have been performed to evaluate commercially available “cell therapy” efficacy or safety. We conducted a review of scientific literature review to assess the level of evidence (LOE) of treatment benefit for commercially-available “cell therapy” treatments in the U.S. for ocular diseases.
A review of scientific literature was performed using PubMed and Google Scholar to grade the LOE for treatment benefit using commercially-available ocular “cell therapy” treatments in the U.S. (Oxford Centre LOE scheme).
Two case series (level 4 evidence) and 3 case reports (level 5 evidence) reported positive outcomes without adverse events. All studies with positive outcomes were registered under the same clinical trial and treated a variety of diseases. The listed outcome measures were visual acuity and fields. One case series (level 4 evidence) and 4 case reports (level 5 evidence) reported severe complications of commercially available “cell therapy” treatments. Stem cell sources included adipose-derived and bone-marrow derived stem cells.
Published series from “cell therapy” clinics emphasize benefits and reported no complications with commercially-available “cell therapies.” However, severe blinding complications after treatments at “cell therapy” clinics have been reported by the physicians who managed the complications. The medical and scientific community need to continue educating the public about the potential risks associated such with commercially available “cell therapy” treatments.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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