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

March 21, 2011
April 23, 2014
March 2011
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01321333 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thoracic Spinal Cord Injury
  • Spinal Cord Injury
  • Spinal Cord Injury Thoracic
  • Spinal Cord Trauma
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
Experimental: HuCNS-SC cells
Single dose intramedullary administration of HuCNS-SC cells
Intervention: Biological: HuCNS-SC cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
December 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Switzerland
 
NCT01321333
CL-N02-SC
Yes
StemCells, Inc.
StemCells, Inc.
Not Provided
Study Chair: Stephen Huhn, MD StemCells, Inc.
StemCells, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP