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Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02959333
Enrollment
10
Registered
2016-11-09
Start date
2016-10-31
Completion date
2017-12-31
Last updated
2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Fistula

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.

Interventions

BIOLOGICALhAEC

hAEC: human amniotic epithelial cells

Sponsors

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
CollaboratorINDUSTRY
The Second Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
median time for fistula closure12 weeks

Secondary

MeasureTime frameDescription
complication1 yearfever, coughing up blood, infection...

Countries

China

Contacts

Primary ContactYimin Zeng, Dr.
zeng_yi_ming@126.com0595-22766122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026