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
About this trial
This is an interventional treatment trial for Bronchial Fistula
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.
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
NCT ID
NCT02959333
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
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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