Cethrin in Acute Cervical Spinal Cord Injury

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.

Inclusion Criteria:

• Males or females, ages 18-62, inclusive
• Acute cervical spinal cord injury at a neurological level of C4-C6
• AIS Grade A or B
• Scheduled to undergo decompression/stabilization surgery within five days of injury
• Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits

Exclusion Criteria:

• Participation in any other clinical trial for acute SCI, including previous Cethrin trial
• Inability to receive study medication within five days of injury
• Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
• Significant hemorrhage on MRI/CT scan
• Females who are breastfeeding or have a positive serum pregnancy test
• Body mass index (BMI) of ≥ 35 kg/m2 at screening
• History of an adverse reaction to a fibrin sealant or its human or bovine components
• Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
• Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
• Unconsciousness or other impairment that precludes reliable ASIA examination
• Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
• Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease