Luxa Biotechnology LLC announced the publication of phase 1/2a clinical trial results in Cell Stem Cell describing the first-in-human study of its proprietary adult retinal pigment epithelial stem cell therapy (RPESC-RPE-4W) for dry age-related macular degeneration (AMD).

The published data report on the low-dose cohort (Cohort 1) of the ongoing phase 1/2a trial (NCT04627428). In this group, 6 participants received a subretinal injection of 50,000 RPESC-RPE-4W cells. In the follow-up period, patients with severe vision loss experienced an average gain of +21.67 Early Treatment Diabetic Retinopathy Study letters maintained through 12 months. Patients with better baseline vision had more modest improvements (+3 letters at 6 months). No tumor formation, severe inflammation, or therapy-related serious adverse events were observed.

Find the full study here.OM