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

Phase 1

Completed

• Conditions: Spinal Cord Injury Thoracic; Spinal Cord Injury; Thoracic Spinal Cord Injury; Spinal Cord Trauma
• Interventions: Biological: HuCNS-SC cells

• Registration Number: NCT01321333
• Lead Sponsor: StemCells, Inc.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HuCNS-SC cells	HuCNS-SC cells	Single dose intramedullary administration of HuCNS-SC cells

Primary Outcome Measures

Name	Time	Method
Types and frequencies of adverse events and serious adverse events	One year after transplant	Analysis of types and frequencies of adverse events one year after transplant.

Trial Locations

Locations (3)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340; 🇨🇭 Zurich, Switzerland