This study is to be performed on patients undergoing surgery after an acute trauma to their spinal cord. BA-210 is a drug that has shown (in the preclinical stages) an ability to protect neurons and to promote their growth. The purpose of this study is to determine the safety and tolerability of BA-210 when administered as a single extradural application. The neurological status of the patients undergoing this study will also be assessed following a certain schedule.

Condition	Treatment or Intervention	Phase
Spinal Cord Injury	Drug: BA-210	Phase I Phase II

Further Study Details: 

Primary Outcomes: Neurological status
Expected Total Enrollment:  38

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Informed Consent Form signed by the patient or patient’s legal representative.

2. Male or female, aged 18-70 years, inclusive.

3. 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.

4. Scheduled to undergo spinal decompression surgery or other interventional spinal surgery (e.g., fixation) within 7 days of injury.

5. American Spinal Injury Association (ASIA) Impairment Scale grade of A (complete, no motor or sensory function present in the sacral segment) as assessed within 12 hours before surgery.

6. Able to communicate effectively to obtain informed consent and to ensure neurological examination.

Exclusion Criteria:

1. Use of any experimental drug, or participation in any clinical trial, within 30 days prior to surgery.

2. History of adverse reaction to fibrin sealant.

3. History of hypersensitivity to bovine products.

4. Any medical condition that may interfere with the ASIA assessments.

5. Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease or malignancy.

6. Hemophilia or other bleeding abnormality as defined by:

• Platelet level lower than 100 X 10^9/L
• Activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal
• Baseline hematocrit lower than 0.25

7. Gunshot wound as the presenting injury, or any evidence of transecting injury to the spinal cord (e.g., by stab wound).

8. Cognitive impairment which may preclude accurate neurological assessments (e.g. traumatic head injury with Glasgow Coma Scale [GCS] of less than or equal to 14).

9. Ankylosing Spondylitis.

10. Diabetes mellitus requiring insulin therapy.

11. Known immunodeficiency, including Acquired Immune Deficiency Syndrome or use of immunosuppressive or cancer chemotherapeutic drugs.

12. 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 the Investigator’s discretion.

13. 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.

14. Any condition likely to result in the patient’s death within the next 6 months.

15. Any other condition that, in the opinion of the Investigator, would preclude the patient’s participation in the study.

16. Previous participation in this study.

17. Use of intravenous heparin in previous 48 hours, thrombolytics and/or aspirin containing products in the previous 10 days.

18. Non-traumatic causes of spinal cord injury (e.g. transverse myelitis, acute disc herniation, etc…).

Margaret Bretin Jones      (514) 282-9990  Ext. 174    margaret.bretinjones@bioaxone.com

Canada, Ontario
      Toronto Western Hospital, Toronto,  Ontario,  M5T-2S8,  Canada; Recruiting

Study ID Numbers:  BA-210-101
Record last reviewed:  February 2005
Last Updated:  February 25, 2005
Record first received:  February 24, 2005
ClinicalTrials.gov Identifier:  NCT00104221
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08