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Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Primary Purpose

Bronchial Fistula

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
hAEC
Sponsored by
The Second Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Fistula

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hAEC treatment

Arm Description

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

Outcomes

Primary Outcome Measures

median time for fistula closure

Secondary Outcome Measures

complication
fever, coughing up blood, infection...

Full Information

First Posted
November 3, 2016
Last Updated
November 7, 2016
Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT02959333
Brief Title
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Official Title
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hAEC treatment
Arm Type
Experimental
Arm Description
hAEC: human amniotic epithelial cells 3-5*10^7 /5 ml
Intervention Type
Biological
Intervention Name(s)
hAEC
Intervention Description
hAEC: human amniotic epithelial cells
Primary Outcome Measure Information:
Title
median time for fistula closure
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
complication
Description
fever, coughing up blood, infection...
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yimin Zeng, Dr.
Phone
0595-22766122
Email
zeng_yi_ming@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Zeng, Dr.
Organizational Affiliation
The Second Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhi Gao, Dr.
Phone
0595-22766122
Email
1564747628@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

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