Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

Early Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Biological: bronchial basal cells

• Registration Number: NCT03156673
• Lead Sponsor: First Affiliated Hospital of Shantou University Medical College

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-13
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bronchial basal cells	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.

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1)	1-6 months	An indicator for pulmonary function test to assess airway obstruction
Forced vital capacity (FVC)	1-6 months	An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation

Secondary Outcome Measures

Name	Time	Method
St. George's respiratory questionnaire (SGRQ) scale	1-6 months	A questionnaire to assess life quality affected by the respiratory problems
Diffusion capacity of CO (DLCO)	1-6 months	An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood
Maximum mid-expiratory flow (MMF)	1-6 months	An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
Maximum voluntary ventilation (MVV)	1-6 months	An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
Modified medical research council (MMRC) chronic dyspnea scale	1-6 months	An indicator to evaluate the level of dyspnea
6-minute-walk test (6MWT)	1-6 months	An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)	1-6 months	An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity

Trial Locations

Locations (1)

the First Affiliated Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guang Dong, China