Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

Official Title
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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

Conditions
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Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Trauma

Intervention / Treatment
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* Biological: HuCNS-SC cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuCNS-SC cells<br>Single dose intramedullary administration of HuCNS-SC cells | Biological: HuCNS-SC cells<br>* single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord<br>* Other names: allogeneic stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic spinal cord injury, spinal cord injury thoracic, sub-acute spinal cord injury, human neural stem cells, stem cells, stem cells transplant, stem cells transplant spinal cord injury