JPRN-UMIN000014434已完成1 期
Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury - Phase I/II study of KP-100IT in acute spinal cord injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •-Spinal cord injury at C1-C2 or C2-C3 level -Patients not able to start rehabilitation within a week, by setup of respirator, or other reason. -First dose of the study drug will not be given within 78 hours since the injury -History of spinal cord injury, abnormality in spinal cavity, or considerable meningeal damage -Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries -High-dose steroid therapy within 30 days before the entry -Patients who have diseases such as serious liver disorder, renal disorder, heart disease, blood dyscrasia, metabolism disorder and infections -History of malignant tumor -Patients who participated in other clinical study within 30 days before the entry -Patients who have allergies to drugs scheduled to be used in the study -Administration of the study drug to the area of spinal cord injury is not appropriate because of intrathecal infections or intrathecal tumor -Patients not able to understand "informed consent" properly -Patients who are nursing or may be pregnant -Investigator considers that the patient is not appropriate for participating in the study
研究者
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