Stem Cells for Treatment of Bronchopleural Fistula

Bronchopleural Fistula Clinical Trial

Official title:

Umbilical Cord Mesenchymal Stem Cells for Treatment of Bronchopleural Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961725
• Other study ID #: SC-BF
• Status: Recruiting
• Phase: Phase 1
• First received: November 3, 2016
• Last updated: November 9, 2016
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: November 2016
• Source: The Second Affiliated Hospital of Fujian Medical University
• Contact: Yimin Zeng, Dr.
• Phone: 0595-22766122
• Email: zeng_yi_ming[@]126.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopleural Fistula
• Fistula

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	closure of the fistula	median time for fistula closure	24 weeks	Yes
Secondary	complication	fever, coughing up blood, infection...	1 year	Yes