- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163876
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
May 31, 2016 updated by: StemCells, Inc.
A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Center
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Ontario
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Toronto, Ontario, Canada, M9R1L5
- Toronto Western Hospital
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California
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Downey, California, United States, 90242
- Rancho Los Amigos National Rehabilitation Center/USC
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Florida
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Systems
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota/Courage Kenny Rehabilitation Institute
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center, Dept of Neurosurgery
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas, Mischer Neuroscience Institute
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah Health Sciences Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin/Froedtert Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects age 18 to 60 years.
- 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:
- History of penetrating SCI.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HuCNS-SC cells
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
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surgery arm
Other Names:
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No Intervention: non-surgery arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in ISNCSCI upper extremity motor scores
Time Frame: Up to one year after enrollment
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Up to one year after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with serious and non-serious adverse events
Time Frame: Up to one year from the time of enrollment
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Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale
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Up to one year from the time of enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stephen Huhn, MD, StemCells, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
June 12, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Estimate)
June 2, 2016
Last Update Submitted That Met QC Criteria
May 31, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-SCI-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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