Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Benign Airway Stenosis and Respiratory Tract Fistula
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cure rate for benign airway stenosis
研究概览
简要总结
Benign airway stenosis and respiratory tract fistula are common types of airway injury. The diseases occurred after endogenous and exogenous stimuli (tuberculosis, tumor, surgery, tracheal intubation) causing damage to the airway mucosa, resulting in scar repair and irreversible loss of airway epithelium. Autologous adipose vascular fraction (stromal vascular fraction, SVF) is a mixture of cells obtained from adipose tissue through digestion and centrifugation, containing a variety of cell types, such as mesenchymal cells, endothelial progenitor cells, endothelial cells, pericytes, and macrophages. Previous studies have shown that SVF can achieve regeneration and wound healing through modulating the immune microenvironment, promoting angiogenesis, thereby promoting endogenous regeneration of the in situ adult stem cells. This project utilizes the tissue repair function of autologous SVF to treat benign airway stenosis and respiratory tract fistula. To clarify the efficacy and safety of autologous SVF in the treatment of airway injury.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 to 75
- •Subjects diagnosed with benign airway stenosis, tracheoesophageal fistula(the sizes of the fistulas less than 2cm), and bronchopleural fistula
- •Subjects willing to accept SVF treatment
- •Subjects tolerant to the bronchoscope
- •Subjects signed informed consent
排除标准
- •Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
- •Subjects with incomplete remission of malignant tumors or with incurable malignant tumors;
- •Subjects with uncontrolled systemic infection;
- •Subjects requiring anti-clotting drugs;
- •Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
- •Subjects with syphilis, HIV, HBV, HCV antibody positive;
- •Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
- •Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
- •Subjects with liver disease or liver damage: ALT, AST, total bilirubin > 2 times the upper limit of the normal value;
- •Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
- •Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
- •Subjects allergic to thrombin;
- •Subjects accepted by any other clinical study within the first three months of the study;
- •Subjects with poor compliance;
- •Any other conditions might increase the risk of the patient or interfere with the clinical study.
结局指标
主要结局
Cure rate for benign airway stenosis
时间窗: within 3 months after administration
The proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after SVF treatment
Cure rate for respiratory tract fistula
时间窗: within 3 months after administration
The proportion of patients who have complete closure of fistula, no need for endotracheal intervention and with stable clinical symptoms after SVF treatment
次要结局
- Times of unplanned treatment(within 3 months after administration)
- Incidence of complications associated with SVF treatment(within 3 months after administration)
- Clinical complete remission time(within 3 months after administration)
研究者
ShiYue Li
Director of Department of Respiratory Medicine
Guangzhou Institute of Respiratory Disease