LTFU Study of Subjects Who Received GRNOPC1
This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
|Condition or Disease
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.
Arms and Interventions
|Subjects treated with GRNOPC1 in the initial dosing study CP35A007
Subjects treated with GRNOPC1 in the initial dosing study CP35A007 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
Primary Outcome Measures
- 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.
- Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.
- There are no exclusion criteria for this LTFU study.
Contacts and Locations
|Northwestern Medical Group
Sponsors and Collaborators
- Lineage Cell Therapeutics, Inc.
- Study Chair: Gary Hogge, DVM, MS, PhD, Lineage Cell Therapeutics, Inc.
Study Documents (Full-Text)None provided.