Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells
NCT ID: NCT03156673
Last Updated: 2017-05-17
Study Results
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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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2017-04-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
75 Years
ALL
No
Sponsors
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Regend Therapeutics
INDUSTRY
Tongji University
OTHER
First Affiliated Hospital of Shantou University Medical College
OTHER
Responsible Party
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Xiaohe Zheng
Chief Physician
Locations
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the First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017112
Identifier Type: -
Identifier Source: org_study_id
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