A clinical trial for Stargardt macular dystrophy using retinal pigment epithelium derived from human embryonic stem cells (hESCs) has received clearance to proceed from drug regulators in the United Kingdom.
Advanced Cell Technology, Inc. (Marlborough, MA), received clearance from the UK Medicines and Healthcare Products Regulatory Agency to conduct the phase 1/2 trial, the first clinical trial of hESCs to be sanctioned in Europe, according to a news release. The trial will include 12 patients and will be led by retinal surgeon James Bainbridge at Moorfields Eye Hospital in central London.
Advanced Cell Technology also recently announced the treatment of the first 2 patients in a phase 1/2 clinical trials for Stargardt macular dystrophy and dry AMD with hESC-derived retinal pigment epithelium cells in the United States. Both patients successfully underwent the outpatient transplantation surgeries, according to the company.
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