Recent results from Asterias Biotherapeutics Inc’s ongoing SCiStar Phase 1/2a clinical trial indicate that AIS-A patients with complete cervical spinal cord injuries showed additional motor function improvement at 6 months and 9 months following administration of 10 million AST-OPC1 cells.
“Recovery of upper extremity motor function is critically important to patients with complete cervical spinal cord injuries, since this can dramatically improve quality of life and their ability to live independently,” says Richard Fessler, MD, the study’s lead investigator.
“Patients in this cohort are seeing what we believe are meaningful improvements in their ability to use their arms, hands, and fingers at 6 months and 9 months following AST-OPC1 administration,” adds Fessler, also a professor in the Department of Neurosurgery at Rush University Medical Center.
In total, six patients were enrolled in the study and received 10 million AST-OPC1 cells. Five of the six patients have now completed their 6-month follow-up, and three of the six patients have completed their 9-month follow-up.
The patients’ upper extremity motor function improvements were measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale.
According to the release, the five patients who have completed at least 6 months of follow-up all saw their early improvements in motor score (UEMS) at 3 months maintained or further increased through their most recent data point (6 months or 9 months)
In addition, all of the patients who completed at least 6 months of follow-up had achieved at least a one motor level improvement over baseline on at least one side, and 40% (two of the five patients) had achieved two motor levels over baseline on at least one side, with one of these patients achieving a two motor level improvement on both sides.
“The results to date in the 10 million cell cohort treated with AST-OPC1 cells show that the improvements in arm, hand, and finger function observed very early in the study have been maintained and in most patients have even been further enhanced over time,” states Steve Cartt, chief executive officer of Asterias Biotherapeutics, in the release.
“These results to date are quite encouraging, and we look forward to initiating discussions with the FDA in mid-2017 to begin to determine the most appropriate clinical and regulatory path forward for this innovative therapy,” he adds.
[Source(s): Asterias Biotherapeutics Inc, PR Newswire]