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January 23 Office of the Food and Drug Administration USA (Food and Drug Administration - FDA) has approved loci the company's application Geron to conduct loci a multicenter phase I clinical trial (CT) GRNOPC1 study therapy based on the use of embryonic stem cells in patients with acute spinal cord injury.
Permission is granted to Geron to start the world's first clinical trials for the therapy loci based on the use of embryonic stem cells in humans, stated in a press release. The design of this study jointly developed by the American Spinal Injury Association (American Spinal Injury Association).
"The loci FDA approval of our application for GRNOPC1 study is one of the most significant loci achievements Geron by now, - said Thomas Okarma (Thomas Okarma), president and chief executive officer. - This is the beginning of a potentially loci new page in the medical treatment carried out without the participation of drugs and leading to a new level of healing - restoring of organs and tissue functions, which will be achieved by replacing healthy cells, introduced loci by injection. The ultimate goal of GRNOPC1 is to achieve functional recovery spinal injection of oligodendrocytes derived from human embryonic stem cells and administered directly to the damaged site of spinal cord patient. "
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