Status:
WITHDRAWN
Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
Lead Sponsor:
BioAxone BioSciences, Inc.
Conditions:
Acute Cervical Spinal Cord Injury
Eligibility:
All Genders
18-62 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 t...
Eligibility Criteria
Inclusion
- Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
- Males or females, 18 through 62 years of age, inclusive
- AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
- Motor neurological level of C5, C6, or C7
- Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
- Must be willing and able to participate in study procedures and assessments
- Must be medically stable
- If of childbearing potential, women must agree to either of the following for the duration of the 12-month trial: (a) abstinence, or (b) if sexually active, to use one of the following methods of birth control: barrier with spermicide, intrauterine device, birth control hormones, or surgical sterilization
- Must provide witnessed verbal authorization for use and disclosure of protected health information (PHI)
Exclusion
- Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
- Subjects who require the use of mechanical ventilation
- Females with a positive serum pregnancy test
- Females who are breastfeeding
- Preexisting SCI
- Subjects who are unable to receive study medication within 72 hours of injury
- Subjects with peripheral nerve injury, brachial plexus injury, or multifocal SCI
- Subjects with injuries that prevent a comprehensive ASIA assessment
- Complete spinal cord transection
- Acute SCI because of gun shot or knife wound
- Subjects who are mentally or medically unstable, or are otherwise unlikely to complete the trial in the judgment of the investigator
- Subjects who present with history of symptomatic cervical spondylotic myelopathy
- Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14
- History of multiple sclerosis or other neuromuscular disorder
- History of an adverse reaction to a fibrin sealant or its human or bovine components
- Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease
- History of cancer (except for basal cell carcinoma)
- Hemophilia or other bleeding abnormality
- Ankylosing spondylitis
- Use of insulin therapy to control diabetes mellitus within 6 months of SCI
- Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs
- Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00610337
Last Update
January 17 2014
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