NCT01649687已完成1 期
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety evaluation
研究概览
简要总结
The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
- •Subject's SARA score at 10~20 points.
- •Ages between 20~70 years.
- •Signed informed consent from the patient and/or guardian.
排除标准
- •Subjects enrolled in any other cell therapy studies within the past 30 days.
- •Pregnancy test positive.
- •Subjects deemed to be not suitable for the study by the investigator.
结局指标
主要结局
Safety evaluation
时间窗: 12 months
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
次要结局
- Positron emission tomography(9 months)
- Assessment of language and swallowing functions(12 months)
- Evaluation of syncope(12 months)
- Alterations in SARA score(12 months)
- Balance test(12 months)
- Magnetic resonance spectroscopy(12 months)
研究者
Oscar Kuang-Sheng Lee
Director of Stem Cell Research Centre
National Yang Ming Chiao Tung University
研究点 (1)
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