NCT00695149终止1 期
Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Motor function
研究概览
简要总结
This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury is confirmed with MRI
- •Methylprednisolone therapy according to this study can be started within 8 hours after the injury
- •Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury
- •Age between 15 and 60
- •With the informed consent of obtaining bone marrow and injecting incubated BMSCs.
排除标准
- •Complete disruption of spinal cord
- •Central spinal cord injury
- •Spinal canal stenosis before the injury
- •Brain or spinal cord disease before the injury
- •Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody
- •Pregnancy
结局指标
主要结局
Motor function
时间窗: six months
次要结局
- Sensation(six months)
研究者
研究点 (2)
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