FDA gives ACT clearance for another embryonic stem cell trial

Advanced Cell Technology just announced via press release that the Food and Drug Administration has approved their application for the second clinical trial using cells derived from embryonic stem cells. They will test retinal cells created from human embryonic stem cells in patients with Stargardt’s Macular Dystrophy, a juvenile eye disease which eventually leads to blindness.

The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation to patients with advanced SMD. A total of twelve patients will be enrolled in the study at multiple clinical sites.