Stem Cells for Treatment of Bronchopleural Fistula

Sponsor

The Second Affiliated Hospital of Fujian Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02961725

Collaborator

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China (Industry)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bronchopleural 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 umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.

Condition or Disease	Intervention/Treatment	Phase
Bronchopleural Fistula	Biological: UCMSC	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Umbilical Cord Mesenchymal Stem Cells for Treatment of Bronchopleural Fistula

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UCMSC treatment UCMSC: umbilical cord mesenchymal stem cells	Biological: UCMSC UCMSC: umbilical cord mesenchymal stem cells 3-5*10^7/5 ml

Arm

Intervention/Treatment

Experimental: UCMSC treatment

UCMSC: umbilical cord mesenchymal stem cells

Biological: UCMSC

UCMSC: umbilical cord mesenchymal stem cells 3-5*10^7/5 ml

Outcome Measures

Primary Outcome Measures

closure of the fistula [24 weeks]
median time for fistula closure

Secondary Outcome Measures

complication [1 year]
fever, coughing up blood, infection...

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosed with bronchopleural fistula by imaging or bronchoscopic examination
typical symptom of bronchopleural 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian	China	362000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Yimin Zeng, Dr., The Second Affiliated Hospital of Fujian Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Second Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT02961725

Other Study ID Numbers:

SC-BF

First Posted:

Nov 11, 2016

Last Update Posted:

Nov 11, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Fistula

Study Results

No Results Posted as of Nov 11, 2016