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

Cervical Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02163876
• Other study ID #: CL-SCI-201
• Status: Terminated
• Phase: Phase 2
• First received: June 12, 2014
• Last updated: May 31, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: StemCells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Cervical Spine Injury
• Spinal Cord Injuries
• Spinal Injuries
• Spine Injury

Intervention

Drug:
• HuCNS-SC cells
surgery arm

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Toronto Western Hospital	Toronto	Ontario
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Maryland Medical Systems	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Rancho Los Amigos National Rehabilitation Center/USC	Downey	California
United States	University of Texas, Mischer Neuroscience Institute	Houston	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin
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 Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
StemCells, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ISNCSCI upper extremity motor scores		Up to one year after enrollment	No
Secondary	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	Up to one year from the time of enrollment	No

External Links

•   Study Website