A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord I… (NCT00500812) | Clinical Trial Compass
CompletedPhase 1/2
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
United States48 participantsStarted 2005-02
Plain-language summary
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.
Who can participate
Age range16 Years – 70 Years
SexALL
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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 interna…
What they're measuring
1
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.