Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety will be determined by the assessment of major adverse events
研究概览
简要总结
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.
详细描述
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.
Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.
Clinical results will be analyzed after completion of 14 days of followup.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Signed informed consent
- •* Age between 35 and 70 y
- •* Acute onset within 7 days.
- •* Oxygenation index:200\35mmHg
- •* Bilateral infiltrates on chest radiography
- •* No cardiac failure
排除标准
- •Declined to sign informed consent
- •Socially and mentally disabilities
- •Malignant diseases
- •Combined with severe infectious diseases
- •Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
- •Pregnant or perinatal women
- •Severe diseases of any major organs
结局指标
主要结局
Safety will be determined by the assessment of major adverse events
时间窗: From day 0 at the start of treatment to day 14.
Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.
次要结局
- The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8(6 hours post-infusion, and days 1, 2, and 3)
- The efficacy of UC-MSC treatment was measured by arterial blood gas analysis(Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.)
- The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6(6 hours post-infusion, and days 1, 2, and 3)
- Quantify pulmonary respiratory function measured by chest computerized tomography(Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.)