Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
NCT ID: NCT02163876
Last Updated: 2016-06-02
Study Results
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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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2014-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HuCNS-SC cells
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
HuCNS-SC cells
surgery arm
non-surgery arm
non-surgery arm
No interventions assigned to this group
Interventions
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HuCNS-SC cells
surgery arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
* American Spinal Injury Association Impairment Scale (AIS) Grades B or C
* Minimum of 12 weeks post-injury prior to Screening
Exclusion Criteria
* MRI evidence of complete spinal cord interruption .
* Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
* Prior participation in another investigational study within 90 days prior to Screening.
* Previous organ, tissue, bone marrow transplantation, or gene transfer
* History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy
18 Years
60 Years
ALL
No
Sponsors
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StemCells, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Huhn, MD
Role: STUDY_DIRECTOR
StemCells, Inc.
Locations
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Rancho Los Amigos National Rehabilitation Center/USC
Downey, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland Medical Systems
Baltimore, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota/Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, United States
Mount Sinai Medical Center, Dept of Neurosurgery
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas, Mischer Neuroscience Institute
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Foothills Medical Center
Calgary, Alberta, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Ahuja CS, Fehlings M. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury. Stem Cells Transl Med. 2016 Jul;5(7):914-24. doi: 10.5966/sctm.2015-0381. Epub 2016 Apr 29.
Related Links
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Spinal Cord Injury Program
Study Website
Other Identifiers
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CL-SCI-201
Identifier Type: -
Identifier Source: org_study_id
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