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

ABSTRACT:

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 3.0×10⁵ palucorcel administered via a transvitreal route. A sample of the ERM was retained for analysis following the ERM peeling procedure. Clinical out

SUBMITTER: Spencer R 

PROVIDER: S-EPMC5640410 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature