Tuesday, October 18, 2011

Europe’s First Embryonic Stem Cell Trial Approved

    A U.S.-based company has received permission to start Europe’s fi rst clinical trial involving human embryonic stem (hES) cells. Advanced Cell Technology (ACT), based in Marlborough, Massachusetts, received approval 22 September from the U.K. Medicines and Healthcare products Regulatory Agency to begin a trial that will treat 12 patients with Stargardt’s macular dystrophy. The disease strikes people between the ages of 10 and 20, causing progressive vision loss. There is currently no treatment. The new trial is the fi rst one using hES cells to receive approval outside the United States, says Robert Lanza, ACT’s chief scientific officer.
     Eye surgeon James Bainbridge of Moorfields Eye Hospital and University College London will lead the U.K. trial. He and his colleagues will inject into patients’ eyes retinal pigment epithelial cells derived from hES cells. In animal models, the cells have been able to stave off or even reverse disease progression. The phase I/II trial will primarily examine the treatment’s safety.



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