NCT00500812已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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...).
研究组 & 干预措施
1 mg
Experimental
Subjects receiving 1 mg Cethrin
干预措施: Cethrin (Drug)
0.3 mg
Experimental
Subjects Receiving 0.3 mg Cethrin
干预措施: Cethrin (Drug)
3 mg
Experimental
Subjects receiving 3 mg Cethrin
干预措施: Cethrin (Drug)
6 mg
Experimental
Subjects receiving 6 mg Cethrin
干预措施: Cethrin (Drug)
9 mg
Experimental
Subjects receiving 9 mg Cethrin
干预措施: Cethrin (Drug)
结局指标
主要结局
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.
时间窗: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months
次要结局
- Efficacy by AIS(Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months)
研究者
研究点 (8)
Loading locations...
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