A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
NCT ID: NCT00500812
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2005-02-28
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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0.3 mg
Subjects Receiving 0.3 mg Cethrin
Cethrin
1 mg
Subjects receiving 1 mg Cethrin
Cethrin
3 mg
Subjects receiving 3 mg Cethrin
Cethrin
6 mg
Subjects receiving 6 mg Cethrin
Cethrin
9 mg
Subjects receiving 9 mg Cethrin
Cethrin
Interventions
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Cethrin
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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…).
16 Years
70 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J. Fehlings, MD, PhD, FRCSC, FACS
Role: PRINCIPAL_INVESTIGATOR
Univestity Health Network, Toronto Western
Locations
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
University of Cincinnati Mayfield Clinic and Spine Institute
Cincinnati, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Univ.of Virginia Health System
Charlottesville, Virginia, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
Sunnybrooke Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Countries
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References
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McKerracher L, Anderson KD. Analysis of recruitment and outcomes in the phase I/IIa Cethrin clinical trial for acute spinal cord injury. J Neurotrauma. 2013 Nov 1;30(21):1795-804. doi: 10.1089/neu.2013.2909. Epub 2013 Oct 1.
Fehlings MG, Theodore N, Harrop J, Maurais G, Kuntz C, Shaffrey CI, Kwon BK, Chapman J, Yee A, Tighe A, McKerracher L. A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. J Neurotrauma. 2011 May;28(5):787-96. doi: 10.1089/neu.2011.1765.
Related Links
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Other Identifiers
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BA-210-101
Identifier Type: -
Identifier Source: org_study_id
NCT00104221
Identifier Type: -
Identifier Source: nct_alias
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