MIAMI — Cell therapy with CNTO 2476, sales an adult stem cell treatment for atrophic age-related macular degeneration, ailment is well tolerated when delivered safely into the subretinal space, a speaker told colleagues at Angiogenesis, Exudation, and Degeneration 2015.
Of the 35 subjects with bilateral geographic atrophy enrolled in the study, 33 received the cells via microcatheter.
“In this study, we need to do a better job with surgical delivery,” Allen C. Ho, MD, said, considering there was a 15% rate of retinal detachment with the method used. No patient had immune response, endophthalmitis, uveitis or tumor formation, however.
Ho gave early efficacy results on visual acuity accrued in the phase 1/2a clinical trial, but “with caution,” because the trial was small, unmasked and not controlled.
Mean visual acuity over 1 year in treated eyes improved four to five letters, whereas fellow eyes that were untreated lost approximately two letters, according to the presentation.
About 25% of treated eyes gained three lines of vision or more in best corrected visual acuity over 1 year, whereas no untreated eyes improved by that measure.
The strategy for therapy in this trial and in future trials of this cell line is to harvest adult umbilical tissue-derived cells without differentiation and to inject them subretinally to support or repair the diseased cells with cytokines or cell-to-cell interaction, according to the presentation.
“All the cells for this trial and the future trials will be derived from a single umbilical cord,” Ho said, with the cells being expanded according to good tissue practices, quality tested and cryopreserved into aliquots for delivery into the study subject’s eye.
A phase 2b randomized controlled trial is planned to begin in 2016, with an enrollment goal of 160 patients, Ho said – by Patricia Nale, ELS
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