Human Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Infusion associated events
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.
详细描述
This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. A salvage package of 10^6/kg suspended UCMSCs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed.
This is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged≥18 years old;
- •Including all the criteria:
- •(1) Invasive ventilation, OI（PaO2/FiO2）<200; (2) PEEP≥8cmH2O; (3) Bilateral infiltration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI<200 after protective ventilation or conservative fluid management.
排除标准
- •Any malignant disease;
- •Cardiogenic pulmonary edema;
- •Over 50% atelectasis either lung lobe in X-ray;
- •Pregnancy or perinatal or lactation;
- •Previous end stage respiratory disease;
- •More than 3 organs failure;
- •Liver failure with MELD(Model For End-Stage Liver Disease) score>40;
- •Stage III or IV pulmonary hypertension;
- •None invasive arterial and central venous catheter;
- •Concurrent deep venous thrombus or pulmonary embolism in 3 months;
- •Cerebral hernia;
- •More than 96 hours after ARDS onset.
研究组 & 干预措施
UCMSCs group
Intravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min.
干预措施: umbilical cord derived mesenchymal stem cells (UCMSCs) suspension (Biological)
UCMSCs group
Intravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min.
干预措施: normal saline (Biological)
结局指标
主要结局
Infusion associated events
时间窗: From infusion beginning to the second day, 24 hours
Incidence of prescribed adverse events or unprescribed events agreed by investigators and consultant .
Mortality
时间窗: In 60 days after enrolled
All cause mortality. Cause of death, exact survival status (death/survival) and time (days) will also be recorded
次要结局
- Driving pressure(From day 0 to day 7, each day)
- Plateau pressure(Pplat)(From day 0 to day 7, each day)
- Static compliance(From day 0 to day 7, each day)
- Ventilation free days(VFDs)(From the day of UCMSCs use(day 0) to day 28)
- Positive end expiratory pressure(PEEP)(From day 0 to day 7, each day)
- Oxygenation index(OI) changes(From day 0 to day 7, each day)
- Lung injury score(LIS)(From day 0 to day 7, day0,1,3,7)
研究者
Lv Haijin
attending physician
Sun Yat-sen University