Back to resultsStudy of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
Primary Purpose
Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HuCNS-SC cells
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Spinal Cord Injury focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Foothills Medical Center
- Toronto Western Hospital
- University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HuCNS-SC cells
Arm Description
Single dose intramedullary administration of HuCNS-SC cells
Outcomes
Primary Outcome Measures
Types and frequencies of adverse events and serious adverse events
Analysis of types and frequencies of adverse events one year after transplant.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01321333
Brief Title
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StemCells, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Trauma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HuCNS-SC cells
Arm Type
Experimental
Arm Description
Single dose intramedullary administration of HuCNS-SC cells
Intervention Type
Biological
Intervention Name(s)
HuCNS-SC cells
Other Intervention Name(s)
Human central nervous system stem cells, allogeneic stem cells
Intervention Description
single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
Primary Outcome Measure Information:
Title
Types and frequencies of adverse events and serious adverse events
Description
Analysis of types and frequencies of adverse events one year after transplant.
Time Frame
One year after transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Huhn, MD
Organizational Affiliation
StemCells, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N-2T9
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
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