NCT02611609已完成1 期
A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Healios K.K.
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- Frequency of sustained hypoxemia or hypotension
研究概览
简要总结
A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe ARDS, as defined by the Berlin definition, requiring an endotracheal or tracheal tube
- •Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion
排除标准
- •Concurrent illness that shortens life expectancy to less than 6 months
- •Other serious medical or psychiatric illness
研究组 & 干预措施
Cohort 1
Experimental
Low dose MultiStem
干预措施: MultiStem (Biological)
Cohort 3
Experimental
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
干预措施: Placebo (Biological)
Cohort 3
Experimental
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
干预措施: MultiStem (Biological)
Cohort 2
Experimental
High dose MultiStem
干预措施: MultiStem (Biological)
结局指标
主要结局
Frequency of sustained hypoxemia or hypotension
时间窗: 4 hours
Suspected Unexpected Serious Adverse Reactions (SUSARs)
时间窗: 24 hours
次要结局
- Frequency of adverse events(Up to 365 days)
- Changes in vital signs(Up to 7 days)
- Changes in blood safety laboratories(Up to 7 days)
- Ventilator-free days(28 days)
- ICU-free days(28 days)
- Total length of hospital stay(28 days)
- All-cause mortality(Up to Day 365)
- Changes in levels of oxygenation(Up to 28 days)
- Changes in positive end-expiratory airway pressure(Up to 28 days)
- Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)(Up to Day 365)
- All-cause mortality(28 days)
研究者
研究点 (10)
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