Clinical trial NCT02163876: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Spinal Cord Injury
Spine Injury
Cervical Spine Injury
Keywords: spine
injury
trauma
spine injury
cervical spine injury
cervical spine
stemcells transplantation
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in ISNCSCI upper extremity motor scores
timeFrame: Up to one year after enrollment
Secondary outcomes:
measure: Number of participants with serious and non-serious adverse events
timeFrame: Up to one year from the time of enrollment
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center/USC
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Systems
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota/Courage Kenny Rehabilitation Institute
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center, Dept of Neurosurgery
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas, Mischer Neuroscience Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: StemCells, Inc.
name: Stephen Huhn, MD
role: STUDY_DIRECTOR
References:
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.