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

NCT ID: NCT01321333

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HuCNS-SC cells

Single dose intramedullary administration of HuCNS-SC cells

Group Type EXPERIMENTAL

HuCNS-SC cells

Intervention Type BIOLOGICAL

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

Interventions

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HuCNS-SC cells

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Human central nervous system stem cells allogeneic stem cells

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StemCells, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Huhn, MD

Role: STUDY_CHAIR

StemCells, Inc.

Locations

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Foothills Medical Center

Calgary, Alberta, Canada

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Canada Switzerland

Related Links

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http://www.stemcellsinc.com/Therapeutic-Programs/Overview.htm

Click here for more information on this study

Other Identifiers

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CL-N02-SC

Identifier Type: -

Identifier Source: org_study_id

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