Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
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
1 other identifier
interventional
12
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 18, 2015
June 1, 2015
4.1 years
March 21, 2011
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
HuCNS-SC cells
EXPERIMENTALSingle dose intramedullary administration of HuCNS-SC cells
Interventions
single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemCells, Inc.lead
Study Sites (3)
Foothills Medical Center
Calgary, Alberta, T2N-2T9, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
Zurich, Canton of Zurich, 8008, Switzerland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Huhn, MD
StemCells, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 23, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 18, 2015
Record last verified: 2015-06