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

NCT05975424 | Active Not Recruiting FDA Drug

• 1 other identifier: AST-OPC1-02
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in neurologic function as assessed by the ISNCSCI

  Up to 5 years after AST-OPC1 injection

Study Arms (1)

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)

Interventions

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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

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

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lineage Cell Therapeutics, Inc.: lead

Study Sites (6)

University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 35901693 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for immune response monitoring and xenotransplantation safety samples.

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gary Hogge, DVM, MS, PhD

  Lineage Cell Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 3, 2023
• Study Start: June 13, 2018
• Primary Completion (Estimated): January 14, 2033
• Study Completion (Estimated): January 14, 2033
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)