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Advanced Cell Technology (OTC BB: ACTC) receives Approval for First hESC Trial in EU

Moorfields Eye Hospital in London is Site for P1/2 Trial to Treat Stargardt’s Macular Dystrophy


OTCBB: ACTC has received clearance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin treating patients as part of a P1/2 clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelium (RPE) derived from human embryonic stem cells (hESCs).

The Bottom Line: ACT received similar approval from the Gene Therapy Advisory Committee (GTAC), which has responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies in theU.K. The European Medicines Agency (NYSEMKT:EMA) previously granted Orphan Drug designation for RPE cell product for use in treating SMD. This is the 1st time an embryonic stem cell trial has ever been approved anywhere else in the world.