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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioAxone BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT00500812
First received: July 11, 2007
Last updated: August 21, 2014
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Drug: Cethrin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioAxone BioSciences, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy by AIS [ Time Frame: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2005
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.3 mg
Subjects Receiving 0.3 mg Cethrin
Drug: Cethrin
(BA-210)
Experimental: 1 mg
Subjects receiving 1 mg Cethrin
Drug: Cethrin
(BA-210)
Experimental: 3 mg
Subjects receiving 3 mg Cethrin
Drug: Cethrin
(BA-210)
Experimental: 6 mg
Subjects receiving 6 mg Cethrin
Drug: Cethrin
(BA-210)
Experimental: 9 mg
Subjects receiving 9 mg Cethrin
Drug: Cethrin
(BA-210)

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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…).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500812

Locations
United States, Arizona
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
United States, Ohio
University of Cincinnati Mayfield Clinic and Spine Institute
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Univ.of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, Ontario
Sunnybrooke Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Sponsors and Collaborators
BioAxone BioSciences, Inc.
Investigators
Principal Investigator: Michael J. Fehlings, MD, PhD, FRCSC, FACS Univestity Health Network, Toronto Western
  More Information

Additional Information:
Publications:
Responsible Party: BioAxone BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT00500812     History of Changes
Obsolete Identifiers: NCT00104221
Other Study ID Numbers: BA-210-101
Study First Received: July 11, 2007
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by BioAxone BioSciences, Inc.:
biologic drug
transport sequence
rho
spinal cord injury
paralysis
paraplegia
tetraplegia
quadraplegia
trauma
nervous system
fibrin sealant
neurosurgery

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014