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Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163876
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : June 16, 2014
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Spine Injury Cervical Spine Injury Drug: HuCNS-SC cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HuCNS-SC cells
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
 Drug: HuCNS-SC cells
surgery arm
Other Names:
  • human neural stem cells
  • HuCNS-SC
  • HCNS-SC
No Intervention: non-surgery arm
non-surgery arm


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in ISNCSCI upper extremity motor scores [ Time Frame: Up to one year after enrollment ]

Secondary Outcome Measures :
  1. Number of participants with serious and non-serious adverse events [ Time Frame: Up to one year from the time of enrollment ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163876


Locations
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United States, California
Rancho Los Amigos National Rehabilitation Center/USC
Downey, California, United States, 90242
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Medical Systems
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota/Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, United States, 55414
United States, New York
Mount Sinai Medical Center, Dept of Neurosurgery
New York, New York, United States, 10029
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas, Mischer Neuroscience Institute
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M9R1L5
Sponsors and Collaborators
StemCells, Inc.
Investigators
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Study Director: Stephen Huhn, MD StemCells, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT02163876    
Other Study ID Numbers: CL-SCI-201
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Keywords provided by StemCells, Inc.:
spine
injury
trauma
spine injury
 cervical spine injury
cervical spine
stemcells transplantation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries