Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula
Primary Purpose
Benign Airway Stenosis, Respiratory Tract Fistula
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Control group
SVF group
Sponsored by
About this trial
This is an interventional treatment trial for Benign Airway Stenosis focused on measuring Stromal Vascular Fraction
Eligibility Criteria
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.
Sites / Locations
- Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
SVF group
Arm Description
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
SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Clinical complete remission time
The interval time of the first intratracheal interventional therapy needed again after SVF treatment
Times of unplanned treatment
The number of times a patient needs to be reviewed and treated by bronchoscopy
Incidence of complications associated with SVF treatment
Wound healing, sputum retention, etc. during follow-up
Full Information
NCT ID
NCT05270850
First Posted
February 26, 2022
Last Updated
March 19, 2022
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT05270850
Brief Title
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula
Official Title
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Benign Airway Stenosis and Respiratory Tract Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Airway Stenosis, Respiratory Tract Fistula
Keywords
Stromal Vascular Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
SVF group
Arm Type
Experimental
Arm Description
SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
SVF group
Intervention Description
SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula
Primary Outcome Measure Information:
Title
Cure rate for benign airway stenosis
Description
The proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after SVF treatment
Time Frame
within 3 months after administration
Title
Cure rate for respiratory tract fistula
Description
The proportion of patients who have complete closure of fistula, no need for endotracheal intervention and with stable clinical symptoms after SVF treatment
Time Frame
within 3 months after administration
Secondary Outcome Measure Information:
Title
Clinical complete remission time
Description
The interval time of the first intratracheal interventional therapy needed again after SVF treatment
Time Frame
within 3 months after administration
Title
Times of unplanned treatment
Description
The number of times a patient needs to be reviewed and treated by bronchoscopy
Time Frame
within 3 months after administration
Title
Incidence of complications associated with SVF treatment
Description
Wound healing, sputum retention, etc. during follow-up
Time Frame
within 3 months after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, MD
Phone
86-020-83062885
Email
lishiyue@188.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyu Song, MD
Phone
86-020-83062885
Email
songxy_2021@163.com
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
Phone
8620-83062896
Email
lishiyue@188.com
First Name & Middle Initial & Last Name & Degree
Xinyu Song, MD
Phone
8620-83062896
Email
songxy_2021@163.com
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula
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