NCT02959333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 3, 2016

Last Update Submit

November 7, 2016

Conditions

Bronchial Fistula

Outcome Measures

Primary Outcomes (1)

  • median time for fistula closure

    12 weeks

Secondary Outcomes (1)

  • complication

    1 year

Study Arms (1)

hAEC treatment

EXPERIMENTAL

hAEC: human amniotic epithelial cells 3-5\*10\^7 /5 ml

Biological: hAEC

Interventions

hAECBIOLOGICAL

hAEC: human amniotic epithelial cells

hAEC treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • absolute contraindication of bronchoscopic examination and treatment
  • with previous treatment of cell therapy, including stem cells.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

RECRUITING

MeSH Terms

Conditions

Bronchial Fistula

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory Tract FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Yimin Zeng, Dr.

    The Second Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yimin Zeng, Dr.

CONTACT

0595-22766122zeng_yi_ming@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 9, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

CN(1)