Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- unconsciousness
研究概览
简要总结
ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.
详细描述
In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-65
- •both gender
- •duration of disease<2 years
- •FVC>40% ALS-FRS>26
排除标准
- •neurological and psychiatric concomitant disease
- •concomitant systemic disease
- •treatment with corticosteroid,Ig,immunosuppressive during 12 months.
结局指标
主要结局
unconsciousness
时间窗: 6months
evaluation the rate of unconsciousness during 6months after stem cell injection.
vomiting
时间窗: 48hours
evaluation the rate of vomiting 48hours after stem cell injection.
brain hematoma
时间窗: 48hours
Evaluation the rate of hematoma 48hours after stem cell injection.
fever
时间窗: 48hours
evaluation the rate of fever 48hours after stem cell injection
次要结局
- EMG-NCV(6months)
- ALS-FRS(6months)