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: January 17, 2014
Last verified: May 2012

July 11, 2007
January 17, 2014
February 2005
December 2008   (final data collection date for primary outcome measure)
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 ]
The primary goal of this study is to determine the safety and tolerability of BA 210 when administered in conjunction with fibrin sealant to the dura mater of the spinal cord.
Complete list of historical versions of study NCT00500812 on ClinicalTrials.gov Archive Site
Efficacy by AIS [ Time Frame: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months ] [ Designated as safety issue: No ]
The secondary goals of this study are to evaluate: • The pharmacokinetic (PK) profile of BA 210 • The neurological status of patients as measured by the ASIA assessment • The appropriate dose range for BA 210 in humans with SCI
Not Provided
Not Provided
 
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
Drug: Cethrin (BA-210)
0.3, 1, 6, 6 or 9 mg of Cethrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2009
December 2008   (final data collection date for primary outcome measure)

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…).
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00500812
BA-210-101
Yes
BioAxone BioSciences, Inc.
BioAxone BioSciences, Inc.
Not Provided
Principal Investigator: Michael J. Fehlings, MD, PhD, FRCSC, FACS Univestity Health Network, Toronto Western
BioAxone BioSciences, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP