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

Primary Purpose

Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HuCNS-SC cells
Sponsored by
StemCells, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury focused on measuring spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitation Center/USC
  • University of Miami Miller School of Medicine
  • Northwestern University
  • University of Maryland Medical Systems
  • University of Michigan Health System
  • University of Minnesota/Courage Kenny Rehabilitation Institute
  • Mount Sinai Medical Center, Dept of Neurosurgery
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center
  • University of Texas, Mischer Neuroscience Institute
  • University of Utah Health Sciences Center
  • Medical College of Wisconsin/Froedtert Hospital
  • Foothills Medical Center
  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HuCNS-SC cells

non-surgery arm

Arm Description

Intramedullary transplantation of HuCNS-SC cells in the cervical spine

non-surgery arm

Outcomes

Primary Outcome Measures

Change from baseline in ISNCSCI upper extremity motor scores

Secondary Outcome Measures

Number of participants with serious and non-serious adverse events
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

Full Information

First Posted
June 12, 2014
Last Updated
May 31, 2016
Sponsor
StemCells, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02163876
Brief Title
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Based on a business decision unrelated to any safety concerns.
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StemCells, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury
Keywords
spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HuCNS-SC cells
Arm Type
Experimental
Arm Description
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
Arm Title
non-surgery arm
Arm Type
No Intervention
Arm Description
non-surgery arm
Intervention Type
Drug
Intervention Name(s)
HuCNS-SC cells
Other Intervention Name(s)
human neural stem cells, HuCNS-SC, HCNS-SC
Intervention Description
surgery arm
Primary Outcome Measure Information:
Title
Change from baseline in ISNCSCI upper extremity motor scores
Time Frame
Up to one year after enrollment
Secondary Outcome Measure Information:
Title
Number of participants with serious and non-serious adverse events
Description
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
Time Frame
Up to one year from the time of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Huhn, MD
Organizational Affiliation
StemCells, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center/USC
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland Medical Systems
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota/Courage Kenny Rehabilitation Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Mount Sinai Medical Center, Dept of Neurosurgery
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas, Mischer Neuroscience Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9R1L5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27130222
Citation
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.
Results Reference
derived
Links:
URL
https://sciresearchstudy.com
Description
Study Website

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

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