Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Healios K.K.
- 入组人数
- 134
- 试验地点
- 32
- 主要终点
- Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
研究概览
简要总结
A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.
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 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 83 years of age (inclusive)
- •Clinical diagnosis of cortical cerebral ischemic stroke
- •Occurrence of a moderate to moderately severe stroke
排除标准
- •Presence of a lacunar or a brainstem infarct
- •Reduced level of consciousness
- •Major neurological event such as stroke or clinically significant head trauma within 6 months of study
研究组 & 干预措施
Cohort 1
Low dose MultiStem or Placebo
干预措施: Placebo (Biological)
Cohort 2
High dose MultiStem or Placebo
干预措施: Placebo (Biological)
Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
干预措施: Placebo (Biological)
Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
干预措施: MultiStem (Biological)
Cohort 1
Low dose MultiStem or Placebo
干预措施: MultiStem (Biological)
Cohort 2
High dose MultiStem or Placebo
干预措施: MultiStem (Biological)
结局指标
主要结局
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
时间窗: 90 days
frequency of dose limiting adverse events
时间窗: 7 days
次要结局
- proportion of subjects with a mRS score of less than or equal to 2(90 days)
- change in functional outcome throughout range of mRS scores(90 days)
- changes in outcome measures (mRS, NIHSS, BI) over time(365 days)
- proportion of subjects with an excellent functional outcome(90 days)
- frequency of secondary infections(365 days)
- frequency of adverse events(365 days)
- change in vital signs(365 days)
- change in safety labs(365 days)