The Wills Eye Institute has received institutional review board approval as a site for a phase I/II clinical trial for nonexudative (dry) age-related macular degeneration using human embryonic stem cell-derived retinal pigment epithelial cells from Advanced Cell Technology Inc.
Philadelphia-The Wills Eye Institute has received institutional review board (IRB) approval as a site for a phase I/II clinical trial for nonexudative (dry) age-related macular degeneration (AMD) using human embryonic stem cell-derived retinal pigment epithelial (RPE) cells from Advanced Cell Technology Inc. (ACT).
The trial is a prospective, open-label study designed to determine the safety and tolerability of the human embryonic stem cell (hESC)-derived RPE cells following subretinal transplantation into patients with dry AMD. It ultimately will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Which patients will be enrolled at the Wills Eye Institute will be determined soon.
“Degenerative diseases of the retina often lead to a significant visual impairment,” said Carl Regillo, MD, director of clinical retina research at Wills Eye Institute and professor of ophthalmology at Thomas Jefferson University. “Replacing lost or damaged cells with functional and healthy cells may provide a treatment option that could slow vision loss, and perhaps even reverse the effects of disease. We are looking forward to collaborating with ACT to evaluate the potential of the stem cell-derived RPE cells for debilitating diseases such as Stargardt’s macular dystrophy and dry AMD.”
Gary Rabin, chairman and chief executive officer of ACT, said, “This clinical trial represents the culmination of years of innovation and hard work by ACT’s scientific team.”
Additional details about these studies, for which the Jules Stein Institute at the University of California, Los Angeles, also has received IRB approval, can be found at http://clinicaltrials.gov/; ClinicalTrials.gov Identifier: NCT01345006 and NCT01344993.
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