NCT01769872已完成1 期
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
R-Bio1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- ASIA (American Spinal Injury Association) scale
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand and sign the consent form for this study
- •Age : 19-70
- •Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
- •Duration of injury : > 3 month
排除标准
- •Subjects who must put on a respirator
- •Subjects who had malignant tumor within 5 years
- •Subjects with a infectious disease include HIV and hepatitis
- •Subjects who injured brain or spinal cord before spinal cord injury
- •Subjects with anemia or thrombocytopenia
- •Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
- •Subjects with congenital or acquired immunodeficiency disorders
- •Patients with clouded consciousness or speech disorder
- •treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
- •participating another clinical trials within 3 months
- •other serious disease or disorder that could seriously affect ability to participate in the study
结局指标
主要结局
ASIA (American Spinal Injury Association) scale
时间窗: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
次要结局
- Magnetic Resonance Imaging(32 weeks)
- SF-36(32 weeks)
- ADL (activities of daily living)(32 weeks)
- MEP/SSEP(32 weeks)
- ODI (Oswestry Disability Questionnaire)(32 weeks)
- Frequency of Adverse Events(32 weeks)
研究者
研究点 (1)
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