Stem Cells for Treatment of Bronchopleural Fistula

NCT ID: NCT02961725

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchopleural Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCMSC treatment

UCMSC: umbilical cord mesenchymal stem cells

Group Type EXPERIMENTAL

UCMSC

Intervention Type BIOLOGICAL

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

Interventions

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UCMSC

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role collaborator

The Second Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yimin Zeng, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Fujian Medical University

Locations

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The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yimin Zeng, Dr.

Role: CONTACT

Phone: 0595-22766122

Email: [email protected]

Facility Contacts

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Hongzhi Gao, Dr.

Role: primary

Other Identifiers

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SC-BF

Identifier Type: -

Identifier Source: org_study_id