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Completed

NCT Number: NCT01321333

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

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.

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Key information

Conditions

Thoracic Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Trauma Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HuCNS-SC cells

Biological

single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord

Other names: Human central nervous system stem cells, allogeneic stem cells

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

StemCells, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2011
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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