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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Fistula; Benign Airway Stenosis
• Intervention / Treatment: Procedure: Control group; Procedure: SVF group

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyu Song, MD; Phone Number: 86-020-83062885; Email: songxy_2021@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Xinyu Song, MD; Phone Number: 8620-83062896; Email: songxy_2021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; 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
Experimental: SVF group; SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula.	Procedure: SVF group; SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stromal Vascular Fraction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Fistula; Constriction, Pathologic; Respiratory Tract Fistula
• Other Study ID Numbers: 20220210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No