A Phase II, Randomized-Controlled Trial of AST-OPC1 in Patients with Spinal Cord Injuries
Phase of Trial: Phase II
Latest Information Update: 24 Jan 2019
At a glance
- Drugs OPC 1 (Primary)
- Indications Spinal cord injuries
- Focus Therapeutic Use
- Sponsors Asterias Biotherapeutics
- 24 Jan 2019 According to an Asterias Biotherapeutics media release, the Company held a Type B meeting with the Food and Drug Administration (FDA) late last year where FDA agreed with the companys plan to initiate this trial.
- 31 Oct 2018 According to an Asterias Biotherapeutics media release, the positive feedback received from the Panel will strengthen the meeting with the FDA later this year.Assuming successful execution of the FDA meeting and obtainment of additional CIRM funding or alternative financing, the company expect to enroll the first patient in this trial in first half of 2020.
- 31 Oct 2018 According to an Asterias Biotherapeutics media release, the company announces positive outcome from an independent Data Review Panels review of the data from the phase I/IIa trial (NCT02302157).Based on review of the data, the Panel recommended moving forward with the continued clinical development of OPC1.The next step in the development of OPC1 is a meeting with the FDA to later this year to discuss proposed next steps which also includes this phase II trial design(281618).