MA09-hRPE cells: Phase I/II data
An open-label, dose-escalation, U.S. Phase I/II trial in 9 SMD patients ages >18 who 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. In 8 evaluable patients with 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 3 eyes, remained stable (change of <=10 letters) in 4 eyes and decreased by 11 letters in 1 eye. In 7 evaluable patients with 12 months of follow-up, visual acuity improved by >=15 letters in 3 eyes, remained stable in 3 eyes and decreased by >10 letters in 1 eye. Patients received sub-retinal transplantation of 50,000, 100,000 or 150,000 RPE cells in 1 eye. Data were published in The Lancet. ...