Industry News — Clinical Updates
StemCells, Inc. Advances AMD Clinical Trial to Final Cohort
StemCells, Inc. (Newark, CA) has announced that it transplanted its HuCNS-SC (purified human neural stem cells) into the first 5 patients in the final cohort of its 16-patient Phase I/II trial for geographic atrophy of age-related macular degeneration (AMD). Each of the 8 patients in this second cohort will receive a dose of 1 million stem cells into the more affected eye.
The Phase I/II trial evaluates the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The investigation is divided into 2 sequential cohorts, with patients enrolled in each cohort based on best-corrected visual acuity (BCVA) as determined by the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) acuity test.
Patients with less severe BCVA of 20/320 to 20/100 in the study eye were enrolled in cohort II. Patients with BCVA ≤20/400 in the study eye were enrolled in cohort I. Cohort I consists of 4 patients who were each transplanted with 200,000 stem cells, followed by 4 patients who were each transplanted with 1 million cells.
HuCNS-SC cells are administered by a single injection into the more affected eye. Patients are evaluated using conventional and state-of-the-art methods to assess safety and vision improvement. Evaluations take place at predetermined intervals over a 1-year period, and patients will be followed for an additional 4 years in a separate observational study.
Updated May 27, 2014