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

StemCells, Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thoracic Spinal Cord Injury Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Trauma

Interventions

HuCNS-SC cellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (3)

Foothills Medical Center

Calgary, Alberta, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Types and frequencies of adverse events and serious adverse events

Analysis of types and frequencies of adverse events one year after transplant.

Time frame: One year after transplant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.