Spinal Cord Injury Clinical Trial
Official title:
A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI) - T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT) - ASIA Impairment Scale (AIS) Grade A, B, or C - Minimum of six weeks post injury for the initiation of screening - Must have evidence of preserved conus function - Must be at stable stage of medical recovery after injury Exclusion Criteria: - History of traumatic brain injury without recovery - Penetrating spinal cord injury - Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma - Previous organ, tissue or bone marrow transplantation - Previous participation in any gene transfer or cell transplant trial - Current or prior malignancy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Center | Calgary | Alberta |
Canada | Toronto Western Hospital | Toronto | Ontario |
Switzerland | University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340 | Zurich |
Lead Sponsor | Collaborator |
---|---|
StemCells, Inc. |
Canada, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Types and frequencies of adverse events and serious adverse events | Analysis of types and frequencies of adverse events one year after transplant. | One year after transplant | Yes |
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