CIRM Funded Clinical Trials

A Phase I/IIa Dose Escalation Safety Study of AST-OPC1 in Patients with Cervical Sensorimotor Complete Spinal Cord Injury


Jane Lebkowski
Disease Area: 
Investigator:
CIRM Grant:
Award Value:
$14,323,318
Trial Stage: 
Phase 1/2
Trial Status: 
Active, not recruiting
Targeted Enrollment:
35
ClinicalTrials.gov ID:
Details: 

Up to 12,000 Americans suffer a spinal cord injury (SCI) each year. This condition leads to a high level of permanent disability and decreased life expectancy. Currently, there are no approved therapies for patients with SCI. Asterias Biotherapeutics uses cells derived from embryonic stem cells to heal the spinal cord at the site of injury. They mature the stem cells into brain cells called oligodendrocyte precursor cells that are injected at the injury site where it is hoped they can repair the insulating layer, called myelin, that normally protects the nerves in the spinal cord.

Design: 

Open label, single arm, dose escalation safety study.

Goal: 

Safety. Dosing. Efficacy - motor improvement.

Updates: 

Ongoing. Favorable safety profile to date, interim analysis confirms safety. Improvement in upper extremity motor function through 9 months post-treatment in cohort 2.