Benign Airway StenosisNCT05270850
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula
A study testing SVF group in people with Benign Airway Stenosis and Respiratory Tract Fistula, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Benign Airway Stenosis, Respiratory Tract Fistula
- What is being tested?
- SVF group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shiyue Li, MD, 8620-83062896, lishiyue@188.com
Xinyu Song, MD, 8620-83062896, songxy_2021@163.com
About this study
Official title: 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.
- Conditions
- Benign Airway Stenosis, Respiratory Tract Fistula
- Being tested
- Control group, SVF group
- Keywords
- Stromal Vascular Fraction
- Medical subject headings
- Respiratory Tract Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupProcedure or surgery
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 groupProcedure or surgery
SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Control group |
| SVF group | Experimental | SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula. Receives: Procedure: SVF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 3 months after administration
Secondary outcomes (3)
Clinical complete remission time
The interval time of the first intratracheal interventional therapy needed again after SVF treatment
Measured: within 3 months after administration
Times of unplanned treatment
The number of times a patient needs to be reviewed and treated by bronchoscopy
Measured: within 3 months after administration
Incidence of complications associated with SVF treatment
Wound healing, sputum retention, etc. during follow-up
Measured: within 3 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start20 Mar 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Airway StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270850
- Sponsor's protocol ID
- 20220210
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Benign Airway Stenosis and Respiratory Tract Fistula
- ClinicalTrials.gov ID
- NCT05270850
- Acronym / sponsor ID
- 20220210
- Conditions
- Benign Airway Stenosis, Respiratory Tract Fistula
- Keywords
- Stromal Vascular Fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Control groupConventional 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 group | Experimental | Procedure: SVF groupSVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupConventional 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 or surgery | Control group |
| SVF groupSVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula | Procedure or surgery | SVF group |
Primary outcome
Cure rate for benign airway stenosis
Time frame: within 3 months after administration
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
Time frame: within 3 months after administration
The proportion of patients who have complete closure of fistula, no need for endotracheal intervention and with stable clinical symptoms after SVF treatment
3 secondary outcomes
Clinical complete remission time
Time frame: within 3 months after administration
Times of unplanned treatment
Time frame: within 3 months after administration
Incidence of complications associated with SVF treatment
Time frame: within 3 months after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SVF group in people with Benign Airway Stenosis and Respiratory Tract Fistula, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, MD (86-020-83062885, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate for benign airway stenosis (time frame: within 3 months after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.