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

N/AActive Not RecruitingNCT05975424

Lineage Cell Therapeutics, Inc.25 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (6)

University of Southern California

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Shepherd Center

Atlanta, Georgia, United States

RUSH University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events (AEs)

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.

Time frame: Up to 15 years after AST-OPC1 injection

Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1

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.

Time frame: Up to 5 years after AST-OPC1 injection

Changes at the injection site as monitored by MRI

MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1

Time frame: Up to 5 years after AST-OPC1 injection

Secondary Outcomes

Changes in neurologic function as assessed by the ISNCSCI

Subject baseline results will be compared against changes in motor and sensory examination results

Time frame: Up to 5 years after AST-OPC1 injection

Data from ClinicalTrials.gov

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