Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156673
• Other study ID #: 2017112
• Status: Recruiting
• Phase: Early Phase 1
• First received: May 13, 2017
• Last updated: May 16, 2017
• Start date: April 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2017
• Source: First Affiliated Hospital of Shantou University Medical College
• Contact: Xiaohe Zheng, M.D.
• Phone: 086-0754-88258290
• Email: 70229120[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 ?-?);

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Shantou University Medical College	Shantou	Guang Dong

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital of Shantou University Medical College	Regend Therapeutics, Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)	An indicator for pulmonary function test to assess airway obstruction	1-6 months
Primary	Forced vital capacity (FVC)	An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation	1-6 months
Secondary	Diffusion capacity of CO (DLCO)	An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood	1-6 months
Secondary	The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)	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	1-6 months
Secondary	Maximum mid-expiratory flow (MMF)	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	1-6 months
Secondary	Maximum voluntary ventilation (MVV)	An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute	1-6 months
Secondary	6-minute-walk test (6MWT)	An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases	1-6 months
Secondary	Modified medical research council (MMRC) chronic dyspnea scale	An indicator to evaluate the level of dyspnea	1-6 months
Secondary	St. George's respiratory questionnaire (SGRQ) scale	A questionnaire to assess life quality affected by the respiratory problems	1-6 months