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

Active, not recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT05975424
• Lead Sponsor: Lineage Cell Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2018-06-13
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2033-01-14
• Study Completion: 2033-01-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01	Magnetic Resonance Imaging (MRI)	Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	Up to 15 years after AST-OPC1 injection	Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.
Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1	Up to 5 years after AST-OPC1 injection	Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.
Changes at the injection site as monitored by MRI	Up to 5 years after AST-OPC1 injection	MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1

Secondary Outcome Measures

Name	Time	Method
Changes in neurologic function as assessed by the ISNCSCI	Up to 5 years after AST-OPC1 injection	Subject baseline results will be compared against changes in motor and sensory examination results

Trial Locations

Locations (6)

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

RUSH University Medical Center; 🇺🇸 Chicago, Illinois, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States