U.S. Biotech Gets Approval for Stem Cell Trial in Europe

(Photos8.com)

Advanced Cell Technology Inc. in Marlborough, Massachusetts has received clearance from authorities in the U.K. to begin treating patients with compounds derived from human embryonic stem cells (hESCs) as part of a clinical trial. The approval from the U.K. Medicines and Healthcare Products Regulatory Agency involves a test of retinal pigment epithelium (RPE) from hESCs to treat Stargardt’s Macular Dystrophy.

Stargardt’s Macular Dystrophy, also known as Stargardt disease, is a common form of inherited juvenile macular degeneration, where progressive vision loss is caused by the death of photoreceptor cells in the central portion of the retina called the macula. This new trial will be a prospective, open-label study testing for the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced Stargardt’s Macular Dystrophy, and is similar in design to a clinical trial in the U.S. begun in July.

Advanced Cell Technology received similar approval from the U.K.’s Gene Therapy Advisory Committee, which has responsibility for ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies. The European Medicines Agency previously granted orphan drug designation for the company’s RPE cell product for use in treating the disease.

The trial will take place at Moorfields Eye Hospital in London under  the direction of James Bainbridge, consultant surgeon at the hospital and chair of retinal studies at University College London.

Read more: FDA Clears Stem Cell Trial for Macular Degeneration

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