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BioTime, Inc. Message Board

futurequestnow 1 post  |  Last Activity: Aug 27, 2014 7:17 PM Member since: Oct 1, 2004
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  • futurequestnow by futurequestnow Aug 27, 2014 7:17 PM Flag

    "In four of the five subjects, serial MRI scans performed throughout the 2 to 3 year follow-up period indicate that reduced spinal cord cavitation may have occurred and that AST-OPC1 may have had some positive effects in reducing spinal cord tissue deterioration....
    AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams to assess the safety and activity of the product. Selection of the clinical trial sites is well underway and Asterias expects to begin patient enrollment during the first quarter of 2015.....
    The new clinical trial differs from the original clinical study in that doses up to 10 times higher will be tested. In addition, the trial will focus on patients with neurologically-complete cervical spinal cord injuries. Because of the anatomy of the spinal cord and the existence of more sensitive outcomes measures to assess movement of the arms and hands, it is currently believed that detection of efficacy is much more likely to occur in patients with cervical injuries. It is this patient population that Asterias anticipates will be the target for the first registration clinical trials of AST-OPC1. Asterias expects that the results of the Phase 1/2a clinical trial will provide support for a Phase 2b expansion study that will be conducted to more thoroughly demonstrate safety and efficacy of the product."