The FDA clears Asterias Biotherapeutics (OTCPK:ASTY) to initiate a Phase 1/2a clinical trial of AST-OPC1 in patients with completed cervical spinal cord injury. The trial will assess the safety and activity of escalating doses of AST-OPC1, oligodendrocyte progenitor cells derived from human embryonic stem cells.
The agency approved the next trial phase based on the results of a five-patient Phase 1 trial who had neurologically complete thoracic spinal cord injury. Each patient received a dose of 2M AST-OPC1 cells and have been followed for two to three years. No serious adverse events have been observed.
The Phase 1/2a trial will involve doses up to 10x higher in patients with cervical spinal cord injury. Patient enrollment should commence in Q1 2015. The results will support a Phase 2b trial that will more thoroughly assess the safety and efficacy of AST-OPC1.
The California Institute for Regenerative Medicine awarded the company a grant of $14.3M to help fund the work.