NCT02163876

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
2 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

June 12, 2014

Last Update Submit

May 31, 2016

Conditions

Cervical Spinal Cord InjurySpine InjuryCervical Spine Injury

Keywords

spineinjurytraumaspine injurycervical spine injurycervical spinestemcells transplantation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in ISNCSCI upper extremity motor scores

    Up to one year after enrollment

Secondary Outcomes (1)

  • Number of participants with serious and non-serious adverse events

    Up to one year from the time of enrollment

Study Arms (2)

HuCNS-SC cells

EXPERIMENTAL

Intramedullary transplantation of HuCNS-SC cells in the cervical spine

Drug: HuCNS-SC cells

non-surgery arm

NO INTERVENTION

non-surgery arm

Interventions

HuCNS-SC cellsDRUG

surgery arm

Also known as: human neural stem cells, HuCNS-SC, HCNS-SC
HuCNS-SC cells

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Rancho Los Amigos National Rehabilitation Center/USC

Downey, California, 90242, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota/Courage Kenny Rehabilitation Institute

Minneapolis, Minnesota, 55414, United States

Location

Mount Sinai Medical Center, Dept of Neurosurgery

New York, New York, 10029, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Mischer Neuroscience Institute

Houston, Texas, 77030, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M9R1L5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27130222DERIVED

Related Links

MeSH Terms

Conditions

Spinal InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Back Injuries

Study Officials

  • Stephen Huhn, MD

    StemCells, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 2, 2016

Record last verified: 2016-05

Locations

US(12)CA(2)