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A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

Trial Profile

A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 31 Oct 2018

At a glance

  • Drugs OPC 1 (Primary)
  • Indications Spinal cord injuries
  • Focus Adverse reactions; Proof of concept
  • Acronyms SCi-STAR; SCiSTAR
  • Sponsors Asterias Biotherapeutics
  • Most Recent Events

    • 31 Oct 2018 According to an Asterias Biotherapeutics media release, Asterias worked with the California Institute for Regenerative Medicine (CIRM) to complete the review of the data from this trial under CIRMs Clinical Advisory Panel process. The Panel reviewed the most recent safety, engraftment and efficacy data from the SCiStar study including analysis of the data after removing a small subset of subjects that are likely to be excluded from next trial.
    • 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 generated by patients enrolled in this study.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 the trial design for a phase 2 trial (281618).
    • 12 Sep 2018 Additional data results (Cohort 2; 24-months) presented in an Asterias Biotherapeutics media release.
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