NCT07465198尚未招募2 期
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Autologous Stem Cell Therapy in Patients With Multiple System Atrophy
Biocells Medical1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
研究概览
简要总结
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple System Atrophy (MSA-P or MSA-C)
- •Age range of 35 to 65 years
排除标准
- •Other major neurological disorders
- •Severe cardiac/renal/hepatic impairment
- •Prior stem cell therapy
研究组 & 干预措施
MSC therapy
Experimental
200,000,000 cells per infusion
干预措施: MSCs (Drug)
Saline Solution
Placebo Comparator
0.9% saline infusion
干预措施: Placebo (Other)
结局指标
主要结局
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
时间窗: At week 48 from baseline
次要结局
- Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36)(At week 48 from baseline)
研究者
研究点 (1)
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