NCT06910384终止2 期
An Open Label Study of STR04 in Participants With Amyotrophic Lateral Sclerosis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
研究概览
简要总结
This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis.
详细描述
This study is a 69 week open label study of autologous bone-marrow-derived mesenchymal stem cells (STR04) in participants with ALS.
Participants will undergo a screening visit, followed by collection of peripheral blood and bone marrow for the manufacture of STR04. Once manufacturing is successfully completed, participants will have a Baseline visit followed by 4 doses of STR04, one dose every 12 weeks. Participants will have a final assessments 12 weeks after the 4th dose.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm, Open Label
Other
干预措施: STR04 (Biological)
结局指标
主要结局
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
时间窗: 25 weeks
次要结局
- Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score(49 weeks)
- Change in Percent-predicted forced vital capacity (%FVC)(From Baseline to 25 weeks and 49 weeks)
- Change in Manual Muscle Test (MMT)(From Baseline to 25 weeks and 49 weeks)
- Change in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)(From Baseline to 25 weeks and 49 weeks)
- Change in plasma neurofilament light (NfL)(From Baseline to 25 weeks and 49 weeks)
研究者
研究点 (1)
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