US-based biotechnology firm Asterias Biotherapeutics has started patient enrolment in its Phase I/IIa clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).
First patient was enrolled at Canada-based Shepherd Center, one of the nation’s top rehabilitation hospitals for spinal cord injury and brain injury.
The new trial follows the successful completion of the Phase I trial of AST-OPC1, which was also conducted at the Shepherd Center.
The Phase I trial met its primary endpoints of safety and feasibility when administered to five patients with neurologically complete, thoracic SCI.
In the coming months, the company expects to start patient enrollment for the Phase I/IIa trial at up to seven additional sites.
Shepherd Center medical director and principal investigator for the study site Donald Peck Leslie said: "The Phase I study generated a strong package of data regarding the safety of AST-OPC1.
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"With the Phase I/IIa clinical trial, we are excited to begin testing AST-OPC1 at the doses and in the population where it has the maximum potential to bring benefit to patients."
The an open-label, single-arm Phase I/IIa trial is designed to evaluate the safety and activity of escalating doses of AST-OPC1 for complete cervical SCI, the first targeted indication for AST-OPC1.
The trial will be testing three escalating doses of AST-OPC1 in patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI.
These patients have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs.
During the trial, AST-OPC1 will be administered 14 to 30 days post-injury, while patients will be followed by neurological exams and imaging methods to evaluate the safety and activity of the product.
Rush University Medical Center professor of neurological surgery and principal investigator for the Phase I clinical trial Richard Fessler said: "There are currently no FDA-approved therapeutics or devices for the more than 12,000 individuals who sustain an SCI each year in the US alone, or for the approximately 1.3 million Americans who are estimated to be living with an SCI.
"If AST-OPC1 could deliver even modest improvements in motor or sensory function, it would result in significant improvements in quality of life."
Additionally, the company is seeking FDA concurrence to increase the robustness of the proof of concept in the Phase I/IIa clinical trial by expanding enrolment from 13 patients to up to 40 patients.