Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Phase 1
- Conditions
- Bronchial Fistula
- Interventions
- Biological: hAEC
- Registration Number
- NCT02959333
- Lead Sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Brief Summary
Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.
The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Diagnosed with bronchial fistula by Imaging or bronchoscopic examination
- typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss...
- patients present compromised conditions, who can only accept a conservative treatment.
Exclusion Criteria
- absolute contraindication of bronchoscopic examination and treatment
- with previous treatment of cell therapy, including stem cells.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hAEC treatment hAEC hAEC: human amniotic epithelial cells 3-5\*10\^7 /5 ml
- Primary Outcome Measures
Name Time Method median time for fistula closure 12 weeks
- Secondary Outcome Measures
Name Time Method complication 1 year fever, coughing up blood, infection...
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Fujian Medical University
🇨🇳Quanzhou, Fujian, China