LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1
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 |
|---|---|---|
|
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
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
- 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
- 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
Criteria
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
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.
Investigators
- Study Chair: Gary Hogge, DVM, MS, PhD, Lineage Cell Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- AST-OPC1-02