An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- changes of ALS-FRS score
研究概览
简要总结
The purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.
详细描述
This pilot clinical trial is design to see the safety and possible efficiency of ADSCs treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3 months, 6 months 9 months and 12 months.
Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety before and after brain implantation.
Timing of Study: 12months recruitment period after approvals
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
- 35 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Compassionate Treatment
- •The number of participants for a person.
- •The patients (Guo XX) of 28% of lung function assessment (normal lung function was greater than 80%), the daily life of motor function score was 17 points (normal function score of 40 points).
排除标准
- 未提供
研究组 & 干预措施
Compassionate Treatment
ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation.
干预措施: Autologous Adipose-Tissue Derived Stem Cells (Procedure)
结局指标
主要结局
changes of ALS-FRS score
时间窗: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months
using ALS-FRS score to assess patient's function after transplantation.
changes of respiratory function
时间窗: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
check the changes of respiratory functions after intervention .
changes of neurologic function
时间窗: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
check any changes of neurologic functions after intervention .
次要结局
- changes of brain structure(Baseline-Day 60- 6 mounths-12 mounths)
研究者
Shinn-Zong Lin
Superintendent, China Medical University Beigang Hospital, Taiwan
China Medical University Hospital