NCT02116634撤回1 期
Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
Alzahra Hospital, Iran1 个研究点 分布在 1 个国家开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS
研究概览
简要总结
Whether the mesenchymal injection on ALS patients is effective or not?
详细描述
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sporadic ALS according to escorial criteria
- •onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
- •mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
- •normal polysomnography
- •Signed consent form
排除标准
- •pregnancy or lactation,
- •vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
- •Hospitalization due to serious illness in the last two months
- •survival time less than two years
- •Hypersensitivity to any component used in the cell culture
研究组 & 干预措施
mesenchymal stem cell
Experimental
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
干预措施: mesenchymal stem cell (Biological)
结局指标
主要结局
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS
时间窗: every 6 months up 2 years after transplantation
次要结局
- FVC (forced vital capacity)and DWSE±QoL score(before transplantation and every 6 months up 2 years after transplantation)
- ALS-FRS(functional rating scale) score and EMG scale(before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation)
研究者
rokhsareh meamar
Principal Investigator
Alzahra Hospital, Iran
研究点 (1)
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