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news.US-based StemCells has completed transplantation of the first subject in its Phase II Radiant trial of its HuCNS-SC platform technology (purified human neural stem cells) at the Retina Foundation of the Southwest.
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The trial is designed to evaluate both the safety and efficacy of human neural stem cells for the treatment of geographic atrophy (GA), the most advanced form of dry age-related macular degeneration (AMD).
StemCells Ophthalmology Clinical Development vice-president Joel Naor said: "Initiation of this fellow eye controlled Phase II clinical trial re-affirms our leadership in the study of stem cells to treat disorders of the eye.
"AMD is a debilitating condition that severely impacts quality of life for millions of people and for which there is currently no treatment. HuCNS-SC cells may have the potential to preserve vision in those affected with dry AMD and possibly other degenerative retinal disorders."
The Phase II Radiant trial is enrolling 63 patients between 50-90 years of age with bi-lateral GA-AMD.
In the trial, all subjects will receive subretinal transplantation of HuCNS-SC cells via a single injection into the eye with the inferior best-corrected visual acuity; the untreated eye will serve as a control.
All patients will be followed for 12 months, with evaluations performed at predetermined intervals to evaluate safety, anatomic and functional changes.
The trial’s objective is to demonstrate a reduction in the rate of disease progression in the treated eye versus the control eye.