The Phase 1/2A clinical trial includes 6 patients in the AIS-A 10 million cell cohort. The company’s AST-OPC1 progenitor cell therapy is derived from human embryonic stem cells and has been shown to produce neurotrophic factors, stimulate vascularization and induce remyelination of denuded axons in animal models – functions that are critical for restoring nerve impulses in patients with spinal cord injuries, according to Asterias.
The company said today that data from its ongoing clinical trial confirm motor function improvements 6 months after the administration of AST-OPC1.
“We are excited to see the 6 and final patient in the AIS-A 10 million cell cohort show upper extremity motor function improvement at 3 months and further improvement at 6 months, especially because this particular patient’s hand and arm function had actually been deteriorating prior to receiving treatment with AST-OPC1,” chief medical officer Dr. Edward Wirth III said in prepared remarks. “We are very encouraged by the meaningful improvements in the use of arms and hands seen in the SciStar study to date since such gains can increase a patient’s ability to function independently following complete cervical spinal cord injuries.”
Asterias is measuring improvements in motor function using the International Standards for Neurological Classification of Spinal Cord Injury scale, according to the company. The researchers calculate an upper extremity motor score, which quantifies motor function in the muscle groups that drive arm and hand function, and “motor levels”, which correspond to where on the spinal cord a patient has a minimum level of function.
In all 6 patients, administration of the company’s progenitor cell therapy was followed by improvements in the upper extremity motor score at 3 months. The improvements were sustained or increased at the most recent follow-up point of 6 months.
The company also reported that all 6 patients in the AIS-A 10 million cell cohort have achieved at least 1 motor level improvement over baseline on at least 1 side.
“These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population,” CEO Steve Cartt said. “We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year.”