Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis

Launched by GUANGZHOU INSTITUTE OF RESPIRATORY DISEASE · Mar 26, 2019

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with aged between 18 to 75
• • 2. 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
• • 3. Subjects tolerant to bronchoscope；
• • 4. Subjects signed informed consent
• Exclusion Criteria:
• • 1. Subjects with airway disease:congenital benign central airway stenosis, recurrent polychondritis, etc;
• • 2. Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
• • 3. Subjects with malignant tumors or have a history of malignant tumors;
• • 4. Subjects with uncontrolled systemic infection;
• • 5. Subjects requiring anti-clotting drugs;
• • 6. Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
• • 7. Subjects with syphilis, HIV,HBV,HCV antibody positive;
• • 8. Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
• • 9. Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
• • 10. Subjects with liver disease or liver damage: ALT,AST, total bilirubin \> 2 times the upper limit of the normal value;
• • 11. Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
• • 12. Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
• • 13. Subjects allergic to thrombin;
• • 14. Subjects accepted by any other clinical study within the first three months of the study;
• • 15. Subjects with poor compliance;
• • 16. Any other conditions might increase the risk of the patient or interfere with the clinical study.