This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a complete thoracic injury. Dose levels from 0.3 mg - 9 mg of Cethrin will be administered.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
University of Cincinnati Mayfield Clinic and Spine Institute
Cincinnati, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Univ.of Virginia Health System
The primary goal of this study is to determine the safety and tolerability of Cethrin when administered in conjunction with fibrin sealant to the dura mater of the spinal cord.
Time frame: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months
Efficacy by AIS
Time frame: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months
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Charlottesville, Virginia, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
Sunnybrooke Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada