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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321333
First Posted: March 23, 2011
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
StemCells, Inc.
  Purpose
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.

Condition Intervention Phase
Thoracic Spinal Cord Injury Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Trauma Biological: HuCNS-SC cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by StemCells, Inc.:

Primary Outcome Measures:
  • Types and frequencies of adverse events and serious adverse events [ Time Frame: One year after transplant ]
    Analysis of types and frequencies of adverse events one year after transplant.


Enrollment: 12
Study Start Date: March 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HuCNS-SC cells
Single dose intramedullary administration of HuCNS-SC cells
Biological: HuCNS-SC cells
single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
Other Names:
  • Human central nervous system stem cells
  • allogeneic stem cells

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321333


Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N-2T9
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada
Switzerland
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
Zurich, Switzerland, 8008
Sponsors and Collaborators
StemCells, Inc.
Investigators
Study Chair: Stephen Huhn, MD StemCells, Inc.
  More Information

Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT01321333     History of Changes
Other Study ID Numbers: CL-N02-SC
First Submitted: March 21, 2011
First Posted: March 23, 2011
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by StemCells, Inc.:
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

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Thoracic Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System


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