OCT 08, 2014
Cell Cure Neurosciences Ltd. filed an Investigational New Drug application with the FDA for a phase 1/2a clinical trial of OpRegen, a potential xeno-free stem-cell treatment for dry AMD.
Patients with dry AMD will undergo a single subretinal transplantation of retinal pigment epithelial cells derived from human embryonic stem cells.
Designed as a dose escalation study, the trial will investigate three different doses of OpRegen. Following transplantation, patients will be followed over 12 months to evaluate the treatment’s safety and tolerability. A secondary objective of the study will be to explore the ability of transplanted OpRegento engraft, survive and moderate the disease progression.