Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare the adverse events between mesenchymal stem cell treatment and placebo groups
研究概览
简要总结
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.
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
- Triple (Participant, Care Provider, Investigator)
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
- •ARDS diagnosed using Berlin definition
- •Eligible patients were at least 18 years of age had acute onset of ARDS.
- •Bilateral opacities in chest radiography
- •No cardiac failure
- •PaO2/FiO2 ratio < 200
排除标准
- •72 hours after all inclusion criteria met
- •Pre-existing severe diseases of any major organs
- •Pulmonary hypertension
- •Malignant diseases
- •HIV infections.
研究组 & 干预措施
Placebo
Patients received one dose of normal saline.
干预措施: Placebo (Drug)
Mesenchymal stem cell arm
Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.
干预措施: Mesenchymal stem cells (Drug)
结局指标
主要结局
Compare the adverse events between mesenchymal stem cell treatment and placebo groups
时间窗: From day 0 at the start of treatment to day 28.
次要结局
- Hospital indices by treatment group(From admission to discharge)