Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Bronchial Fistula Clinical Trial

Official title:

Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959333
• Other study ID #: hAEC-BF
• Status: Recruiting
• Phase: Phase 1
• First received: November 3, 2016
• Last updated: November 7, 2016
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: The Second Affiliated Hospital of Fujian Medical University
• Contact: Yimin Zeng, Dr.
• Phone: 0595-22766122
• Email: zeng_yi_ming[@]126.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchial Fistula
• Fistula

Intervention

Biological:
• hAEC
hAEC: human amniotic epithelial cells

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median time for fistula closure		12 weeks	Yes
Secondary	complication	fever, coughing up blood, infection...	1 year	Yes