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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.
ClinicalTrials.gov Identifier:
NCT01321333
First received: March 21, 2011
Last updated: April 23, 2014
Last verified: April 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Analysis of types and frequencies of adverse events one year after transplant.


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT01321333     History of Changes
Other Study ID Numbers: CL-N02-SC
Study First Received: March 21, 2011
Last Updated: April 23, 2014
Health Authority: Switzerland: Swissmedic
Canada: Health Canada
United States: Food and Drug Administration

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:
Retinitis Pigmentosa
Spinal Cord Injuries
Thoracic Injuries
Wounds and Injuries
Spinal Cord Diseases
Trauma, Nervous System
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014