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This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 GRNOPC1 injection |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007
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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 |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Shepherd Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35364569 | Result | McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1. |
| Label | URL |
|---|---|
| Ten-year safety of pluripotent stem cell transplantation in acute thoracic 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
| Atlanta |
| Georgia |
| 30309 |
| United States |
| Northwestern Medical Group | Evanston | Illinois | 60208 | United States |
| D014947 | Wounds and Injuries |