JPRN-UMIN000041030已完成3 期
A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury - A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
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 89years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •-The injury site is C1 - C2 or C2 - C3 -The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary -It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury -A history of spinal cord injury (SCI), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI -Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury -High dose steroid therapy administered for spinal cord injury -Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy -History of malignant tumor -Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration -Drug allergies to drugs that will be (or may be) used -Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass -Problems with the subject's ability to give informed consent in person -The subject is breastfeeding or possibly pregnant -The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator -It is inappropriate for the subject to be included in the study, in the judgement of the investigator
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