As announced this morning, Advanced Cell Technology said that Mass Eye & Ear Infirmary had received IRB approval to become the fourth clinical site for ACT’s embryonic stem cell trials in treating the dry form of age-related macular degeneration.
Harvard’s Mass Eye & Ear joins UCLA’s/Jules Stein, Wills Eye Institute, and Bascom Palmer in the ongoing Phase I/II clinical trial using subretinal injections of embryonic stem cell-derived retinal pigment epithelial cells.
In addition, it is my understanding that Moorfields Eye Hospital in London is awaiting final approval of an IND application to also participate in ACT’s clinical trial for dry AMD, along with its current participation as part of the company’s Stargardt’s disease stem cell clinical trial.
The following information was taken from the company’s news release
"We are delighted to announce that Mass. Eye and Ear will participate as a site for our clinical trial for dry AMD," said Gary Rabin, ACT's chairman and CEO. "Dr. Dean Eliott and his team are deeply committed to finding new treatments for preventing blindness, and we very much look forward to tapping into his expertise and insight into the progression of macular degenerative disorders. The primary teaching hospital for ophthalmology at Harvard Medical School, Mass. Eye and Ear is ranked as among the top ophthalmology hospitals in the country by U.S. News & World Report and has a reputation that is unrivaled."
The Phase I/II trial is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format.
"Dry AMD represents one of the largest unmet medical needs in ophthalmology," commented Dr. Dean Eliott, M.D. a full time retina surgeon, scientist and Associate Director of the Retina Service at Mass. Eye and Ear. "We appreciate the opportunity to get some first-hand experience with the protocol and be involved with the international team that has been assembled around the U.S. and European trials."