Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- SOFA score
研究概览
简要总结
The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.
详细描述
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine > 8μg/kg/min)
- •At least 2 organ failure other than hemodynamic
- •Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)
- •Signature of informed consent (patient/close relative or reliable person)
- •Affiliation to social security plan
排除标准
- •Non-septic shock
- •Nosocomial septic shock
- •PaO2/FiO2 <100
- •Pregnant or breast-feeding woman
- •Brain death
- •Dying person
- •Therapeutic limitations
- •Participation to another current interventional clinical trial or since less than 30 days
研究组 & 干预措施
MSC
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line.
干预措施: Injection of mesenchymal stem cells (Biological)
Placebo
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 250 ml albumin 4%, infused for 30 minutes in central venous line.
干预措施: Injection of albumin alone (Biological)
结局指标
主要结局
SOFA score
时间窗: Day 7 (or death day or day of recovery unit exit if before day 7)
To assess the efficacy of a recovery treatment
次要结局
- Number of living days without catecholamines(Day 28)
- Number of living days without mechanical ventilation(Day 28)
- Number of living days without dialysis(Day 28)
- Duration of residence time in recovery unit(Day of exit from recovery unit, up to 90 days)
- Mortality, across all causes(Day 90)
- Administration safety (i.e. side effects)(up to 90 days)