Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

NCT ID: NCT03156673

Last Updated: 2017-05-17

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

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2022-06-30

Brief Summary

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Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

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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bronchial basal cells

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Group Type EXPERIMENTAL

bronchial basal cells

Intervention Type BIOLOGICAL

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Interventions

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bronchial basal cells

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Aged between 40 to 75;
* Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1\<70% predicted value and FEV1/FVC \< 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
* Clinically stable for more than 4 weeks;
* Tolerant to bronchofiberscope;
* Written informed consent signed.

Exclusion Criteria

* Pregnant or lactating women;
* Patients positive for syphilis, HIV;
* Patients with malignant tumor;
* Patients with serious or significant pulmonary infection and need anti-infection treatment;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
* Patients with a history of abusing alcohol and illicit drug;
* Patients participated in other clinical trials in the past 3 months;
* Patients assessed as inappropriate to participate in this clinical trial by investigator.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regend Therapeutics

INDUSTRY

Sponsor Role collaborator

Tongji University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role lead

Responsible Party

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Xiaohe Zheng

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaohe Zheng, M.D.

Role: CONTACT

086-0754-88258290

Wei Zuo, Ph. D.

Role: CONTACT

Facility Contacts

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Xiaohe Zheng, M. D.

Role: primary

086-0754-88258290

Other Identifiers

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2017112

Identifier Type: -

Identifier Source: org_study_id

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