Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PaO2/FiO2
研究概览
简要总结
The patients suffered from acute lung ininjury (200<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.≤ 3 days (72h)
- •2.Age ≥18 years, ≤65 years
- •3.200<PaO2/FiO2 ≤ 300
- •4.Chest X-ray/chest CT : infiltrates of both lungs
- •5.Need assisted ventilation (ventilation or high flow oxygen therapy)
- •6.No left heart failure, pulmonary edema
- •7.Agree to participate and signe an informed consent
排除标准
- •1.Life expectancy <3 months due to non-respiratory failure
- •2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation
- •3.History of HIV, malignant tumors, or impaired immune function
- •4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.)
- •5.Pregnancy
- •6.Have a serious concomitant disease
- •7.Unable to follow-up
- •8.History of severe allergic reactions or allergy to saline and serum
- •9.Already participated in another clinical study within 12 weeks
- •10.Pulmonary edema caused by other underlying diseases
研究组 & 干预措施
hUC-MSCs treatment
Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.
干预措施: human derived umbilical cord derived mesenchymal stem cells (Biological)
non-cell therapy
Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.
结局指标
主要结局
PaO2/FiO2
时间窗: Day 28
Oxygenation index
PaO2/FiO2
时间窗: Day 14
Oxygenation index
PaO2/FiO2
时间窗: Day 3
Oxygenation index
PaO2/FiO2
时间窗: Day 7
Oxygenation index
次要结局
- the days of ventialtion and hospital stay(Day 28)
- the days of ventialtion and hospital stay(Day 3)
- the days of ventialtion and hospital stay(Day 7)
- the days of ventialtion and hospital stay(Day 14)