NCT05975424

LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1

A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Lineage Cell Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.

Detailed description

Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging (MRI)	Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Timeline

• Start date: 2018-06-13
• Primary completion: 2033-01-14
• Completion: 2033-01-14
• First posted: 2023-08-03
• Last updated: 2024-08-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study