In the past year, we have made significant process in the conduct of our clinical study and in process development efforts. We completed enrollment of the first cohort in our clinical study (The SCiSTAR study). This clinical study will test three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in 13 patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 will be administered 14 to 30 days post-injury and patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product. Additional information on the Phase 1/2a study, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.scistarstudy.com).
The first safety cohort of three patients were enrolled and successfully dosed with 2 million cells. The results of the study continue to support a robust safety profile for AST-OPC1, with no serious adverse events observed in any of the three treated patients to date. We recently reported that the first patient in the study has progressed from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS B injury. This level of recovery is observed in less than 5 percent of our AIS A patients at this stage of their recovery.
The Company expects to begin enrollment of the second dose cohort following Data Monitoring Committee review of the 30-day post-injection safety data from all three patients in 4Q15. The second cohort will enroll five patients who will receive 10 million AST-OPC1 cells.
We also continue to make progress on improving the process for AST-OPC1 manufacture as well as determining additional cellular markers which correlate with potency and the presence of undesired populations of cells. Our focus for process development continues to be identifying a process which is robust and consistently provides high-quality AST-OPC1.