LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1
Active, not recruiting
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT05975424
- Lead Sponsor
- Lineage Cell Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Inclusion Criteria:<br><br> - Subjects who received AST-OPC1 under Study AST-OPC1-01<br><br> - Reconfirmation of consent for long-term follow-up<br><br>Exclusion Criteria:<br><br>•Subjects who, for geographic or compliance reasons, are inappropriate candidates for<br>participation in a long-term follow-up study in the opinion of the Investigator
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AEs);Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1;Changes at the injection site as monitored by MRI
- Secondary Outcome Measures
Name Time Method Changes in neurologic function as assessed by the ISNCSCI