Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cure rate for benign stenosis
研究概览
简要总结
Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Benign central airway stenosis is characterized by airway compromise involving the larynx, trachea, or bronchi and will lead to devastating consequences. Unfortunately, the incidence of this disease is increasing steadily. As most important treatment for benign airway stenosis, respiratory intervention has become one of the most common treatments to fight the disease. However, the restenosis caused by tissue hyperplasia, wound repair and scar formation after treatment is still common, which remains the limitation of respiratory intervention. Long-term efficacy of repeated interventional treatment is unsatisfying, too. Several studies have discovered similar mechanism between stenosis of tracheal to hyperplastic scar of skin, both of which are relative with deep structure injury such as the intrinsic layer of airway mucosa. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of refractory benign airway stenosis to reduce restenosis by inhibit the formation of granulation.
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 with aged between 18 to 75
- •Subjects diagnosed with refractory benign airway stenosis and meet the following conditions: a. Received two or more (including two) interventional treatments such as laser, high-frequency electrosurgical unit, argon plasma coagulation (APC), cryotherapy, balloon dilation, and metal stent placement. b. Restenosis within 1 month after more than 2 times interventional treatments suffering from repeated granulation hyperplasia of wound
- •Subjects tolerant to bronchoscope；
- •Subjects signed informed consent
排除标准
- •Subjects with airway disease:congenital benign central airway stenosis, recurrent polychondritis, etc;
- •Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
- •Subjects with malignant tumors or have a history of 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.
研究组 & 干预措施
Control group
Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
干预措施: Conventional treatment for benign airway stenosis (Procedure)
PRP group
Procedure/Surgery: PRP PRP treatment following the conventional treatment Slow spray / inject autogenous PRP to cover the wound of stenosis. Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
干预措施: Conventional treatment for benign airway stenosis (Procedure)
PRP group
Procedure/Surgery: PRP PRP treatment following the conventional treatment Slow spray / inject autogenous PRP to cover the wound of stenosis. Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
干预措施: PRP (Procedure)
结局指标
主要结局
Cure rate for benign stenosis
时间窗: within 6 months after administration
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
次要结局
- Clinical remission time(6 months after administration)
- Times of unplanned treatment(within 6 months after administration)
- Incidence of complications associated with PRP treatment(within 6 months after administration)
研究者
ShiYue Li
Director of Department of Respiratory Medicine
Guangzhou Institute of Respiratory Disease