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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging (MRI)

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01; Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring	Diagnostic test: Magnetic Resonance Imaging (MRI); Observational study; annual MRI for first 5 years only to monitor changes in the injection site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Up to 5 years after AST-OPC1 injection

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lineage Cell Therapeutics, Inc.
• Investigators: Study Chair: Gary Hogge, DVM, MS, PhD, Lineage Cell Therapeutics, Inc.

Publications and helpful links

General Publications

• Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.

Helpful Links

• A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Estimated): January 14, 2033
• Study Completion (Estimated): January 14, 2033

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: AST-OPC1-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No