LTFU Study of Subjects Who Received GRNOPC1
- Conditions
- Spinal Cord Injuries
- Interventions
- Diagnostic Test: Magnetic Resonance Imaging (MRI)
- Registration Number
- NCT05919563
- Lead Sponsor
- Lineage Cell Therapeutics, Inc.
- Brief Summary
This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
- Detailed Description
Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5
- Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.
- There are no exclusion criteria for this LTFU study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects treated with GRNOPC1 in the initial dosing study CP35A007 Magnetic Resonance Imaging (MRI) Subjects treated with GRNOPC1 in the initial dosing study CP35A007 will be followed for 15-year long-term safety monitoring
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AEs) Up to 15 years after GRNOPC1 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Stanford University
🇺🇸Palo Alto, California, United States
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Northwestern Medical Group
🇺🇸Evanston, Illinois, United States