Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Vascular Resistance from Baseline
研究概览
简要总结
Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.Mesenchymal stem cells (MSCs)are a subset of adult stem cells residing in many tissues, including bone marrow(BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues.It was found that MSCs can significantly improve the pulmonary hemodynamics, lung tissue gross and decrease the pulmonary artery pressure, middle artery thickness and right cardiac hypertrophy by intravenous injection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（1）40-75years （2）Male or female （3）The patients that COPD with moderate to severe pulmonary hypertension (pulmonary systolic pressure more than 40mmHg)in relatively stable period （4）To preliminary assess the Patients'lifetime have more than 6 months （5）According to the researchers' judgment, they can abide by the research protocol or Volunteer to participate in the clinical study, understand the study procedure and sign the informed consent in person.
排除标准
- •Patients with acute myocardial infarction and cardiac surgery in the past 1 month
- •Surgery may be required within 8 weeks
- •patients with prior pneumonectomy or having acute, chronic pulmonary embolism or other serious pulmonary diseases
- •Having a history of malignant tumor
- •Participated in other clinical investigators in the last 6 months
- •To allergic to penicillin, gentamicin, aminoglycoside, human serum albumin and DMEM medium
- •A woman who is planning to pregnancy, gestation, or lactation
- •Other reasons caused Pulmonary hypertension and heart failure caused by other causes;Severe liver and kidney failure;Autoimmune diseases;Patients with infectious diseases
- •According toThe researchers' judgments, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study
- •According to the researcher's judgment, this study is not suitable for other conditions -
研究组 & 干预措施
Intervention group
The MSCs of 1×10*6/kg will be given in Central venous catheterization for injection at a total 100 ml . Once every week#a total of two times. The Conventional drug therapy（expectorant，bronchodilator） is used.
干预措施: adipose derived mesenchymal stem cells (Biological)
Intervention group
The MSCs of 1×10*6/kg will be given in Central venous catheterization for injection at a total 100 ml . Once every week#a total of two times. The Conventional drug therapy（expectorant，bronchodilator） is used.
干预措施: Conventional drug therapy（expectorant，bronchodilator） (Drug)
Control group
The Conventional drug therapy（expectorant，bronchodilator） is used with the control group
干预措施: Conventional drug therapy（expectorant，bronchodilator） (Drug)
结局指标
主要结局
Change in Pulmonary Vascular Resistance from Baseline
时间窗: Baseline, 4, 12 and 24 weeks
次要结局
- Change from Baseline in Participant Quality of Life Using the SF-36(Baseline, 4, 12 and 24 weeks)
- Change in Plasma NT-pro-BNP levels(Baseline, 4, 12 and 24 weeks)
- Change in the IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 (ng/ul)(Baseline, 4, 12 and 24 weeks)
- Incidence of Treatment Adverse(Baseline, 4, 12 and 24 weeks)
- Change in Six Minute Walk distance(Baseline, 4, 12 and 24 weeks)