Spinal Cord Injuries
Conditions
Brief summary
This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.
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.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)
Observational study; annual MRI for first 5 years only to monitor changes in the injection site
Sponsors
Lineage Cell Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed