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

Stopped early · Phase 2

Conditions studied: Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury

In brief

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.

Key facts

Study ID

NCT02163876

Run by

StemCells, Inc.

People needed

31

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.