Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Benign Airway Stenosis and Respiratory Tract Fistula

Conditions
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Benign Airway Stenosis, Respiratory Tract Fistula

Intervention / Treatment
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* Procedure: Control group
* Procedure: SVF group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Conventional treatment for benign airway stenosis Including, but is not limited to laser, high-frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation, and metal stent placement | Procedure: Control group<br>* Conventional treatment for benign airway stenosis Including, but is not limited to laser, high-frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation, and metal stent placement<br>|
| Experimental: SVF group<br>SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula. | Procedure: SVF group<br>* SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate for benign airway stenosis | The proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after SVF treatment | within 3 months after administration | 
| Cure rate for respiratory tract fistula | The proportion of patients who have complete closure of fistula, no need for endotracheal intervention and with stable clinical symptoms after SVF treatment | within 3 months after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical complete remission time | The interval time of the first intratracheal interventional therapy needed again after SVF treatment | within 3 months after administration | 
| Times of unplanned treatment | The number of times a patient needs to be reviewed and treated by bronchoscopy | within 3 months after administration | 
| Incidence of complications associated with SVF treatment | Wound healing, sputum retention, etc. during follow-up | within 3 months after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stromal Vascular Fraction