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

Sponsor

StemCells, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01321333

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Spinal Cord Injury Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Trauma	Biological: HuCNS-SC cells	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Foothills Medical Center	Calgary	Alberta	Canada	T2N-2T9
2	Toronto Western Hospital	Toronto	Ontario	Canada
3	University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340	Zurich		Switzerland	8008