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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| SVF group | Experimental | SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, MD | Contact | 86-020-83062885 | lishiyue@188.com | |
| Xinyu Song, MD | Contact | 86-020-83062885 | songxy_2021@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| SVF group | Procedure | SVF treatment following the conventional treatment for benign airway stenosis and respiratory tract fistula |
|
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 |
| ID | Term |
|---|---|
| D016156 | Respiratory Tract Fistula |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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