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ARTICLE | Clinical News

MA09-hRPE cells: Phase I/II data

October 20, 2014 7:00 AM UTC

An open-label, dose-escalation, U.S. Phase I/II trial in 9 dry AMD patients ages >55 who each received sub-retinal transplantation of MA09-hRPE cells in 1 eye showed no adverse safety issues related to the transplanted tissue and confirmed successful engraftment of the RPE cells. At 6 months of follow-up, visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart improved by >=15 letters in 4 eyes, improved by 11-14 letters in 2 eyes and remained stable (change of <=10 letters) in 3 eyes. In 7 evaluable patients with 12 months of follow-up, visual acuity improved by >=15 letters in 3 eyes, improved by 13 letters in 1 eye and remained stable in 3 eyes. Patients received sub-retinal transplantation of 50,000, 100,000 or 150,000 RPE cells in 1 eye. Data were published in The Lancet. ...