NCT03545607终止3 期
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Healios K.K.
- 入组人数
- 206
- 试验地点
- 78
- 主要终点
- assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
研究概览
简要总结
A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Inclusion Criteria:
- •Male or female subjects ≥18 years of age
- •Clinical diagnosis of ischemic stroke involving cerebral cortex
- •Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
- •A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke
排除标准
- •Presence of a lacunar or a brainstem infarct
- •Comatose state
- •Brain hemorrhage
- •Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study
研究组 & 干预措施
MultiStem
Experimental
1.2 billion cells
干预措施: MultiStem (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
时间窗: 90 days
次要结局
- proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:(90 days)
- proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently(90 days)
研究者
研究点 (78)
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