Asterias Biotherapeutics Inc., a California-based biotechnology company focused on regenerative medicine, recently announced positive results from long-term follow-up studies of five patients – including two treated at Shepherd Center – with thoracic-level spinal cord injury (SCI) who participated in the company’s clinical trial of an investigational product.
Results from Asterias’ Phase 1 clinical trial assessing the safety of a relatively low dose (2 million cells) of AST-OPC1 (oligodendrocyte progenitor cells) administered within 14 days of injury showed, in four of the five patients, reduced spinal cord cavitation as measured by serial MRI scans throughout the four- to five-year follow-up period.. Also, AST-OPC1 appeared to have positive long-term effects on reducing spinal cord tissue deterioration.
“This new long-term follow-up data continues to support the general safety of AST-OPC1 and indicates minimal risk of the transplanted cells having unintended effects,” said Edward Wirth III, M.D., chief medical officer for Asterias. “In detailed immune response monitoring of patients, the results are consistent with long-term cell engraftment, immune system tolerability and an absence of adverse effects. In short, AST-OPC1 does not appear to present any immunological or other long-term safety issues when administered to patients with spinal cord injuries.”
In addition, Asterias announced that recent successes in both the Phase 1 and Phase 1/2a clinical trials of AST-OPC1 supported the FDA’s recent decision to clear expansion of the current Phase 1/2a trial, named SCiStar, from 13 to up to 35 newly injured patients. In the SCiStar trial, the company and its research sites, including Shepherd Center, are testing escalating doses of AST-OPC1 that researchers believe may improve motor function in patients with cervical-level SCI.