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

Phase 2

Terminated

• Conditions: Spine Injury; Cervical Spine Injury; Cervical Spinal Cord Injury
• Interventions: Drug: HuCNS-SC cells

• Registration Number: NCT02163876
• Lead Sponsor: StemCells, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Start: 2014-10
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HuCNS-SC cells	HuCNS-SC cells	Intramedullary transplantation of HuCNS-SC cells in the cervical spine

Primary Outcome Measures

Name	Time	Method
Change from baseline in ISNCSCI upper extremity motor scores	Up to one year after enrollment

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious and non-serious adverse events	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

Trial Locations

Locations (14)

Mount Sinai Medical Center, Dept of Neurosurgery; 🇺🇸 New York, New York, United States

Rancho Los Amigos National Rehabilitation Center/USC; 🇺🇸 Downey, California, United States

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Maryland Medical Systems; 🇺🇸 Baltimore, Maryland, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Minnesota/Courage Kenny Rehabilitation Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States

University of Texas, Mischer Neuroscience Institute; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin/Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States