Human Amniotic Epithelial Cells for Treatment of Bronchia... | NCT02959333

Studies
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

NCT02959333

Sponsor

The Second Affiliated Hospital of Fujian Medical University

Status

Unknown status

Last Update Posted

Nov 9, 2016Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Bronchial Fistula

Interventions

hAEC

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 3, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2016

Last Update Posted Date

Nov 9, 2016Estimated

Name	Class
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hAEC treatment	Experimental	hAEC: human amniotic epithelial cells 3-5*10^7 /5 ml	Biological: hAEC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hAEC	Biological	hAEC: human amniotic epithelial cells	hAEC treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
median time for fistula closure		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
complication	fever, coughing up blood, infection...	1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yimin Zeng, Dr.	Contact	0595-22766122		zeng_yi_ming@126.com

Overall Officials

Name	Affiliation	Role
Yimin Zeng, Dr.	The Second Affiliated Hospital of Fujian Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Fujian Medical University	Recruiting	Quanzhou	Fujian	362000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001983	Bronchial Fistula

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D016156	Respiratory Tract Fistula
D005402	Fistula

Browse Leaves

Not provided

Browse Branches

Not provided