Cethrin in Acute Cervical Spinal Cord Injury

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioAxone BioSciences, Inc.
• Treatments: Fibrin Tissue Adhesive

Criteria

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