Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT02302157
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2014-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Sponsor:
Lineage Cell Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: