Asterias Biotherapeutics concludes recruitment of initial safety cohort for the AST-OPC1 clinical trial

Written by RegMedNet

Asterias Biotherapeutics, Inc. (CA, USA) announced the inclusion of a third patient in their clinical trial investigating the therapeutic applications of oligodendrocyte progenitor cells in spinal cord injury.

Asterias Biotherapeutics, Inc. (CA, USA) is conducting a Phase I/IIa clinical trial into the effects of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) among newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The third patient, who was successfully dosed at Rush University Medical Center (IL, USA), is the final patient included in the initial low-dose (2 million cells) safety cohort. No serious adverse events have occurred among the three patients to date.

The first patient, dosed at Shepherd Center (GA, USA), progressed from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS B injury after 2 months. Donald Peck Leslie (Shepherd Center) commented: “This progress in the first patient is very encouraging and is observed in less than 5 percent of our AIS A patients at this stage of their recovery.”

Richard Fessler (Rush University Medical Center), who administered doses for the second and third patients, added: “The injection procedure went very smoothly for both patients and there were no complications. Both patients recovered quickly from the injection surgery and were able to resume their rehabilitation programs soon afterward.”

The 30-day post-injection safety data from the three patients will be reviewed by the Data Monitoring Committee, after which the company hopes to begin enrollment for the second dose cohort. This cohort will consist of five patients receiving 10 million AST-OPC1 cells.

“The safety data in this first cohort now paves the way for testing the higher doses of AST-OPC1 (10-20 million cells) that we believe correspond most closely to the doses that showed the greatest efficacy in animal studies,” explained Edward Wirth (Asterias Biotherapeutics, Inc.).

“We are encouraged by this performance improvement and are confident in meeting our disclosed timelines,” concluded Pedro Lichtinger (Asterias Biotherapeutics, Inc.) “We expect to provide updates as identified milestones are reached or when major events occur.”

— Written by Daphne Boulicault