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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Diagnostic Test | Observational study; annual MRI for first 5 years only to monitor changes in the injection site |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hogge, DVM, MS, PhD | Lineage Cell Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35901693 | Result | 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. |
| Label | URL |
|---|---|
| A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples for immune response monitoring and xenotransplantation safety samples.
| Palo Alto |
| California |
| 94304 |
| United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| RUSH University Medical Center | Chicago | Illinois | 60612 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| D014947 | Wounds and Injuries |