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Stem Cells for Treatment of Bronchopleural Fistula

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ClinicalTrials.gov Identifier: NCT02961725
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
The Second Affiliated Hospital of Fujian Medical University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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




Primary Outcome Measures :
  1. closure of the fistula [ Time Frame: 24 weeks ]
    median time for fistula closure


Secondary Outcome Measures :
  1. complication [ Time Frame: 1 year ]
    fever, coughing up blood, infection...



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961725


Contacts
Contact: Yimin Zeng, Dr. 0595-22766122 zeng_yi_ming@126.com

Locations
China, Fujian
The Second Affiliated Hospital of Fujian Medical University Recruiting
Quanzhou, Fujian, China, 362000
Contact: Hongzhi Gao, Dr.    0595-22766122    1564747628@qq.com   
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

Responsible Party: The Second Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT02961725     History of Changes
Other Study ID Numbers: SC-BF
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical