Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced that the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA) has received institutional review board (IRB) approval to be a site for its Phase 1/2 human clinical trials for Stargardt’s Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
“It is only appropriate that an institution with the global stature of UCLA’s Jules Stein Eye Institute would be a site for the first-ever clinical trials using embryonic-derived stem cells to treat diseases of the eye, and we could not be more pleased,” said Gary Rabin, interim chairman and CEO of ACT. “One of the world’s foremost institutions for ophthalmology-related clinical trials, the institute represents an ideal partner for both trials, and we are eagerly anticipating starting them as soon as possible.”
The Phase 1/2 trials will be prospective, open-label studies designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD and Dry AMD.
“The outstanding scientific and leadership teams at ACT are extremely impressive. Together, our collaboration has led to both FDA and IRB permission to commence these trials. This signals the long-awaited societal and institutional ‘green light’ to take what will hopefully be a huge step forward into the realm of human stem cell science. I am honored to be leading the clinical collaboration,” said Steven Schwartz, MD, Ahmanson Professor and Retina Division Chief, at UCLA’s Jules Stein Eye Institute and Principal Investigator of the trials.
Date: April 28, 2011
Source: Advanced Cell Technology, Inc.