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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

NCT02302157 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-07-14

Study results available
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Summary

The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

Conditions

  • Cervical Spinal Cord Injury
  • Spine Injury
  • Spinal Cord Trauma

Interventions

BIOLOGICAL

AST-OPC1

One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent

Sponsors & Collaborators

  • Lineage Cell Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Edward D Wirth III, MD, PhD · Asterias Biotherapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302157 on ClinicalTrials.gov