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

Lineage Cell Therapeutics

Status: Active, not recruiting

Conditions: Spinal Cord Injuries

Treatments: Diagnostic Test: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Industry

Identifiers

NCT05975424

AST-OPC1-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who received AST-OPC1 under Study AST-OPC1-01
• Reconfirmation of consent for long-term follow-up

Exclusion criteria

•Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator

Trial design

25 participants in 1 patient group

Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01

Description:

Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI)