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

China20 participantsStarted 2022-03-20

Plain-language 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) 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cure rate for benign airway stenosis

Timeframe: within 3 months after administration

Cure rate for respiratory tract fistula

Timeframe: within 3 months after administration

Trial details

NCT IDNCT05270850

SponsorGuangzhou Institute of Respiratory Disease

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

Contact for this trial

Shiyue Li, MD

86-020-83062885 lishiyue@188.com

View on ClinicalTrials.gov More Benign Airway Stenosis trials