Epiretinal membrane in a subject after transvitreal delivery of palucorcel (CNTO 2476).

Background: A 70-year-old woman with retinitis pigmentosa experienced an epiretinal membrane (ERM) formation and a tractional retinal detachment (RD) following subretinal administration of palucorcel (CNTO 2476), a novel human umbilical tissue-derived cell-based therapy, as part of a Phase I study. The clinical course and results of a histologic examination of the ERM, which was peeled during surgery to repair the RD, are described here.

Methods: In this open-label, first-in-human, Phase I study (NCT00458575), two of seven subjects developed RD, with an ERM formation reported in a woman receiving a targeted dose of 3.

Experience With a Subretinal Cell-based Therapy in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration.

Purpose: To evaluate the safety and tolerability of and clinical response to a single, subretinal dose of human umbilical tissue-derived cells (palucorcel [CNTO-2476]) in the eyes of adults aged ≥50 years with bilateral geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Design: Phase 1/2a, multicenter, open-label, dose-escalation, fellow-eye-controlled study.

Methods: In the phase 1 portion, eyes were assigned to receive a single, subretinal dose of palucorcel (ranging from 6.