NCT02302157

Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Lineage Cell Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-11-26
• Last updated: 2021-07-14
• Results posted: 2021-07-13

Locations

9 sites across 1 country: United States