Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188627
• Other study ID #: 20170206
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 12, 2018
• Est. completion date: December 26, 2019

Study information

• Verified date: March 2023
• Source: Regend Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• 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.);
• Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
• 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 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
Transplantation of autologous bronchial basal cells

Locations

Country	Name	City	State
China	First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
Regend Therapeutics	Southwest Hospital, China, Tongji University

Country where clinical trial is conducted

China, 

References & Publications (1)

Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature1390 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicators for safety	Measured by blood routine test, urine routine test and blood chemistry panels	1-6 months
Primary	Diffusion capacity of CO (DLCO)	One of the indicators in pulmonary function test, 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)	One of the indicators in pulmonary function test, representing 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)	One of the indicators in pulmonary function test, standing 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)	One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute	1-6 months
Secondary	Forced expiratory volume in one second (FEV1)	One of the indicators in pulmonary function test, a marker to assess airway obstruction	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
Secondary	Imaging of lung by high resolution computed tomography (HR-CT)	HR-CT images of lung will be analyzed to indicate the pulmonary structure.	1-6 months
Secondary	Forced vital capacity (FVC)	One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation	1-6 months