The studies are the first to provide evidence of mid- to long-term safety, survival, and potential biologic activity of pluripotent stem cell progeny into humans with any disease.
Advanced Cell Technology, Inc. (ACT) announces positive results from two clinical trials for treatment of macular degeneration. The Phase 1/2 clinical data, published online in The Lancet, show positive long-term safety results using ACT’s proprietary Retinal Pigment Epithelium (RPE) cells to treat Stargardt’s macular degeneration and dry age-related macular degeneration. The publication includes data from 18 U.S.-based patients with at least six months of follow-up post-transplant.
Paul K. Wotton, PhD, President and CEO, said in a statement, “These study results represent an important milestone and strengthen our leadership position in regenerative ophthalmology.” He continued, “We would like to thank the patients for their willingness to participate in these studies. Our findings underscore the potential to repair or replace tissues damaged from diseases. We plan to initiate comprehensive Phase 2 clinical trials for the treatment of both AMD and SMD, two disease states where there is currently no effective treatment.”
The studies are the first to provide evidence of mid- to long-term safety, survival, and potential biologic activity of pluripotent stem cell progeny into humans with any disease. Aside from showing no adverse safety issues linked to the transplanted tissue, anatomic evidence confirmed successful engraftment of the RPE cells, including increased pigmentation at the level of the RPE layer after transplantation in 13 out of 18 patients.
According to the Mayo Clinic, dry macular degeneration is a chronic eye disease that leads to vision loss in the center of one’s field of vision.
Leave a Reply