Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- In-hospital mortality
研究概览
简要总结
This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.
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
- •≥ 18 years of age
- •Viral-induced acute respiratory distress syndrome
- •Ventilator treatment
- •Extracorporeal membrane oxygenation treatment
- •Relatives provide written informed consent
排除标准
- 未提供
结局指标
主要结局
In-hospital mortality
时间窗: During hospital stay, an expected average 2 months
次要结局
- Pulmonary compliance(During ventilator treatment, an expected average of 1 month)
- Pulmonary tidal volume(During ventilator treatment, an expected average of 1 month)
- Adverse events(6 months)
- All-cause mortality(12 months)
- Recovery of organ functions(12 months)
研究者
Karl-Henrik Grinnemo
MD, PhD
Karolinska University Hospital