Enrollment and dosing complete in Phase I/IIa trial of cell therapy for spinal cord injury

Written by Freya Leask

Asterias Biotherapeutics, Inc. has announced that enrolment and dosing in both cohorts in their ongoing trial of OPC-1 for complete cervical spine injury are complete.

Asterias Biotherapeutics, Inc. (CA, USA) has announced that they have completely enrolling and dosing a total of 10 patients with complete cervical spinal cord injury (SCI) with OPC-1. OPC-1 is an oligodendrocyte progenitor population derived from human embryonic stem cells and has previously been shown to be safe in patients with neurologically complete, thoracic spinal cord injury in a dose of 2 million cells.

In these most recent Phase I/IIa trials, five patients with AIS-B grade SCIs received 10 million cells and five with AIS-A received 20 million, the highest dose to be investigated in the SCiStar Phase I/IIa trials. Initial results are expected for both cohorts in January 2018.

“Completing enrollment and dosing of the first cohort of AIS-B patients marks [an] important milestone for our AST-OPC1 program,” explained Edward Wirth, Chief Medical Officer, Asterias. “AIS-B patients have some levels of sensation following their injury but like AIS-A patients have severe spinal cord injuries and no meaningful motor function below the injury site.

“Completing enrollment and dosing of the first cohort of patients receiving 20 million AST-OPC1 cells marks another important milestone for our SCiStar study. The results from this cohort will help us evaluate what is the optimal dose for a future, larger clinical study. We look forward to evaluating the data from our enrolled cohorts as we begin to design the next study for AST-OPC1.”

Under an existing US$14.3 million Strategic Partnerships Award grant from the California Institute for Regenerative Medicine (CA, USA), enrolment and dosing of the fifth patient in this cohort triggers a final US$1.5 million grant payment. Asterias also recently announced that the FDA had accepted an amendment to the research protocol for the SCiStar study, expanding the eligibility criteria to include patients with a C-4 spinal cord injury and extending the dosing window from 14—30 days to 21—42 days post-injury.

To learn more about previous trials of OPC-1 and existing treatments for spinal cord injury, watch #TalkingRegMed episode 1, featuring NeuroCentral Editor Lauren Pulling.

Watch #TalkingRegMed episode 1 now

Sources: http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2286677&date=July+17%2C+2017&title=Asterias+Biotherapeutics+Completes+Enrollment+and+Dosing+of+SCiStar+Study%27s+AIS-A+20+Million+Cell+Cohort; http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2285936&date=July+12%2C+2017&title=Asterias+Biotherapeutics+Completes+Enrollment+and+Dosing+of+SCiStar+Study%27s+AIS-B+10+Million+Cell+Cohort