Asterias Biotherapeutics reported 12-month data for its Phase 1/2a SCiStar study on spinal cord injury treatment.
The study's second cohort included six patients suffering from AIS-A injuries and injected with 10 million AST-OPC1 cells.
Here are five key points:
1. The study is investigating the safety and efficacy of AST-OPC1 cells. AST-OPC1 is "an oligodendrocyte progenitor population derived from human embryonic stem cells."
2. Of these patients, four (or 67 percent) regained two or more motor levels on at least one side.
3. All patients recovered at least one motor level improvement on both sides.
4. One patient regained three motor levels of improvement on one side.
5. The FDA also designated AST-OPC1 a Regenerative Medicine Advanced Therapy.
"The 12-month results suggest that many of the Cohort 2 subjects are seeing a durable clinical benefit above and beyond what you would expect to see from spontaneous recovery following a severe spinal cord injury," said Edward Wirth, III, MD, PhD, Asterias' CMO.