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

Lineage Cell Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Actual Enrollment :
25 participants
Observational Model:
Time Perspective:
Official Title:
A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01
Actual Study Start Date :
Jun 13, 2018
Anticipated Primary Completion Date :
Jan 14, 2033
Anticipated Study Completion Date :
Jan 14, 2033

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033
2 Stanford University Palo Alto California United States 94304
3 Shepherd Center Atlanta Georgia United States 30309
4 RUSH University Medical Center Chicago Illinois United States 60612
5 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
6 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Lineage Cell Therapeutics, Inc.


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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Lineage Cell Therapeutics, Inc. Identifier:
Other Study ID Numbers:
  • AST-OPC1-02
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023