Following successful results from its Phase 1 trial, California company Asterias Biotherapeutics Inc. will now initiate a Phase 1/2a clinical trial of its stem cell product, AST-OPC1, in patients with complete cervical spinal cord injury.
The new clinical trial differs from the original clinical study in that doses up to 10 times higher will be tested. It will be an open-label, single-arm study testing three escalating doses of AST-OPC1 in 13 patients with C5-C7, neurologically-complete cervical spinal cord injury. The cells will be administered 14 to 30 days post-injury. Selection of the clinical trial sites is well underway and the Company expects to begin patient enrollment during the first quarter of 2015.