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

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

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
surgery arm
Other Names:
  • HuCNS-SC
  • human neural stem cells
  • HCNS-SC
No Intervention: non-surgery arm

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
Up to one year after enrollment

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
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
Up to one year from the time of enrollment

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.

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

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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