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