A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin During Surgery for Acute Thoracic and Cervical Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Cethrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be enrolled in this study only if they meet all of the following criteria: Informed Consent Form signed by the patient or patient's legal representative. Male or female, aged 16-70 years, inclusive. For Group 1, patients with acute thoracic (T2-T12) spinal cord injury; for Group 2, patients with acute cervical (C4-T1) spinal cord injury. The site of surgery should be able to accommodate a minimum volume of 2 mL of fibrin sealant. Scheduled to undergo spinal decompression surgery or other interventional spinal surgery (e.g., fixation) within 7 days of injury. ASIA Impairment Scale grade of A (complete, no motor or sensory function present in the sacral segment) as assessed within 12 hours before surgery. Able to communicate effectively to obtain informed consent and to ensure neurological examination. Exclusion Criteria: Patients will not be enrolled in this study if they meet one of the following criteria: Use of any experimental drug, or participation in any clinical trial, within 30 days prior to surgery. History of adverse reaction to fibrin sealant. History of hypersensitivity to bovine products. Any medical condition that may interfere with the ASIA assessments. Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease or malignancy. Hemophilia or other bleeding abnormality as defined by: Platelet level lower than 100 X 109/L Activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal Baseline hematocrit lower than 0.25 Gunshot wound as the presenting injury, or any evidence of transecting injury to the spinal cord (e.g., by stab wound). Cognitive impairment which may preclude accurate neurological assessments (e.g. traumatic head injury with GCS of less than or equal to 14). Ankylosing Spondylitis. Diabetes mellitus requiring insulin therapy. Known immunodeficiency, including Acquired Immune Deficiency Syndrome or use of immunosuppressive or cancer chemotherapeutic drugs. Pregnancy or breastfeeding during the study. A serum pregnancy test will be performed at Screening for female patients of childbearing potential. In addition, patients who are considered likely to be pregnant may be excluded at th Investigator's discretion. Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures or participate in all scheduled study assessments, including follow up through Month 6. Any condition likely to result in the patient's death within the next 6 Months. Any other condition that, in the opinion of the Investigator, would preclude the patient's participation in the study. Previous participation in this study. Use of intravenous heparin in previous 48 hours, thrombolytics and/or aspirin containing products in the previous 10 days. Non-traumatic causes of spinal cord injury (e.g. transverse myelitis, acute disc herniation, etc…).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3 mg<br>Subjects Receiving 0.3 mg Cethrin | Drug: Cethrin<br> <br> * Other names: (BA-210);|
| Experimental: 1 mg<br>Subjects receiving 1 mg Cethrin | Drug: Cethrin<br> <br> * Other names: (BA-210);|
| Experimental: 3 mg<br>Subjects receiving 3 mg Cethrin | Drug: Cethrin<br> <br> * Other names: (BA-210);|
| Experimental: 6 mg<br>Subjects receiving 6 mg Cethrin | Drug: Cethrin<br> <br> * Other names: (BA-210);|
| Experimental: 9 mg<br>Subjects receiving 9 mg Cethrin | Drug: Cethrin<br> <br> * Other names: (BA-210);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy by AIS |  | Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biologic drug, transport sequence, rho, spinal cord injury, paralysis, paraplegia, tetraplegia, quadraplegia, trauma, nervous system, fibrin sealant, neurosurgery