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

NCT05270850 | Unknown

• 1 other identifier: 20220210
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Benign Airway Stenosis; Respiratory Tract Fistula

Keywords

Stromal Vascular Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Clinical complete remission time

  within 3 months after administration

• Times of unplanned treatment

  within 3 months after administration

• Incidence of complications associated with SVF treatment

  within 3 months after administration

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

SVF group

EXPERIMENTAL

SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula.

Procedure: SVF group

Interventions

Control group PROCEDURE

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

Control group

SVF group PROCEDURE

SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula

SVF group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Fistula

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Shiyue Li, MD

CONTACT

86-020-83062885; lishiyue@188.com

Xinyu Song, MD

CONTACT

86-020-83062885; songxy_2021@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Medicine

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: March 20, 2022
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)