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

Sponsor:	StemCells, Inc.
Information provided by (Responsible Party):	StemCells, Inc.
ClinicalTrials.gov Identifier:	NCT01321333

Purpose

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	Intervention	Phase
Thoracic Spinal Cord Injury Spinal Cord Injury	Procedure: HuCNS-SC cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis Help Me Understand Genetics

MedlinePlus related topics: Injuries Spinal Cord Injuries Wounds

U.S. FDA Resources

Further study details as provided by StemCells, Inc.:

Primary Outcome Measures:

Types and frequencies of adverse events and serious adverse events [ Time Frame: One year after transplant ] [ Designated as safety issue: Yes ]
Analysis of types and frequencies of adverse events one year after transplant.

Estimated Enrollment:	12
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HuCNS-SC cells	Procedure: 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321333

Locations

Switzerland
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340	Recruiting
Zurich, Switzerland, 8008
Contact: Armin Curt, MD 41-44-386 3901
Contact: Dagmar Keller-Lang, MD 41 44 386 39 05 Dagmar.Keller@balgrist.ch
Principal Investigator: Armin Curt, MD

Sponsors and Collaborators

StemCells, Inc.

Investigators

Principal Investigator:

Armin Curt, MD

University Hospital Balgrist

More Information

Additional Information:

spinal cord injury trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	StemCells, Inc.
ClinicalTrials.gov Identifier:	NCT01321333 History of Changes
Other Study ID Numbers:	CL-N02-SC
Study First Received:	March 21, 2011
Last Updated:	May 22, 2012
Health Authority:	Switzerland: Swissmedic

Keywords provided by StemCells, Inc.:

thoracic spinal cord injury
spinal cord injury
sub-acute spinal cord injury

Additional relevant MeSH terms:

Retinitis Pigmentosa
Spinal Cord Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases

Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2012