Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- fever
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.
详细描述
the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender
- •Age: 18-55
- •Sporadic form of disease
- •ALS-FRS> = 24
- •FVC >= 40%
排除标准
- •Familial form of ALS
- •Malignancy
- •Autoimmune disease
- •Diagnosis of other motor neuron diseases
研究组 & 干预措施
Stem cell
The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
fever
时间窗: 72hours
The increase of body temperature that is defined as fever, within 72 hours after injection.
Unconsciousness
时间窗: 72hours
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
次要结局
- The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)(2 months)
- FVC(2 months)