Age-related Macular Degeneration (AMD): Clinical Program
Phase II Clinical Trial in GA-AMD (Suspended pending funding TBD)
Based upon both the strength of our pre-clinical studies and the positive results from our Phase I/II clinical trial, StemCells, Inc. has initiated the Radiant™ Study, a Phase II proof-of-concept study using our HuCNS-SC® platform technology for the treatment of advanced dry AMD, also referred to as geographic atrophy (GA). Although we maintain high confidence in the potential of our clinical approach, further enrollment in this study has been suspended while we seek a funding partner.
Phase I/II Trial in GA-AMD (Completed)
In June 2014, based on positive interim results, StemCells, Inc. closed enrollment earlier than planned in its Phase I/II clinical trial to assess the tolerability, safety and preliminary efficacy of subretinal HuCNS-SC transplantation in GA-AMD.
Top-line results for the Phase I/II clinical trial were presented in June 2015. In addition to a favorable safety profile for our HuCNS-SC platform technology, patients demonstrated either stable or improved visual acuity and contrast sensitivity at 6 and 12 months post-transplant. Increased macular volume and foveal thickness was observed in the study eye. Analysis and assessment of changes in RPE defects and GA progression is underway.