Biotech company Advanced Cell Technology today announced it has initiated the dosing of the first patients in each of its phase I/II clinical trials for Stargardt’s macular dystrophy and dry age-related macular degeneration (dry AMD). Both studies were conducted earlier this week using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
Steven Schwartz, M.D., professor of ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute, headed the study to determine the safety and tolerability of hESC-derived RPE cells after sub-retinal transplantation into patients with the Stargardt’s and AMD.
Gary Rabin, interim chairman and CEO, emphasized the importance of the studies and the significance the results represent.
“This first treatment milestone is welcomed by scientists, stem cell advocates and patients hoping for cures,” Rabin stated in the press release. “The two trials could not have started any smoother, and we are very pleased to announce that the procedures went well. The dosing of the first patients represents an important milestone for ACT and opens the doors to a potentially significant new therapeutic approach to treating the many forms of macular degeneration. We believe that these procedures represent a key step forward in therapeutic stem cell research, and the capacity to treat a variety of devastating diseases.”
Dry AMD, Stargardt’s and other forms of atrophy-related macular degeneration are usually untreatable, representing an obvious need for safe and effective therapies to treat these common forms of blindness.
Robert Lanza, M.D., chief scientific officer of Advanced Cell, attended the clinical procedures, and noted the years of research and development the scientific field has achieved in regenerative therapy studies. He also commented on the need for continued efforts to combat debilitating conditions.
“Today –13 years after the discovery of human embryonic stem cells – the great promise of these cells is finally being put to the test,” said Dr. Lanza. “The initiation of these two clinical trials marks an important turning point for the field. While we will continue writing research papers and carrying out more research, it’s time to start moving these exciting new stem cell therapies out of the laboratory and into the clinic. Tens of thousands of people continue to die every day from diseases that could potentially be treated using stem cells. In the meantime, we intend to accelerate our efforts to translate new embryonic stem cell (ES) and induced pluripotent stem (iPS) cell therapies into the clinic. It has taken years of extensive research to get to this point. Our research and preclinical studies have demonstrated the safety and effectiveness of such therapies. We hope these cells may provide a treatment option not only for degenerative eye diseases, but for a wide spectrum of other debilitating conditions, ranging from diabetes to vascular and autoimmune diseases. Our team remains committed to moving the field of regenerative medicine forward from bench to bedside.”
For more information visit www.advancedcell.com