Status:
UNKNOWN
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Conditions:
Benign Airway Stenosis
Respiratory Tract Fistula
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05270850
Start Date
March 20 2022
End Date
July 1 2023
Last Update
March 22 2022
Active Locations (1)
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1
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120