Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Biological: Bronchial basal cells

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Conventional treatment
Experimental: Bronchial basal cells; Transplantation of autologous bronchial basal cells	Biological: Bronchial basal cells; Transplantation of autologous bronchial basal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicators for safety	Measured by blood routine test, urine routine test and blood chemistry panels	1-6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Forced expiratory volume in one second (FEV1)	One of the indicators in pulmonary function test, a marker to assess airway obstruction	1-6 months
6-minute-walk test (6MWT)	An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases	1-6 months
Modified medical research council (MMRC) chronic dyspnea scale	An indicator to evaluate the level of dyspnea	1-6 months
St. George's respiratory questionnaire (SGRQ) scale	A questionnaire to assess life quality affected by the respiratory problems	1-6 months
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
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

Collaborators and Investigators

• Sponsor: Regend Therapeutics
• Collaborators: Southwest Hospital, China; Tongji University

Publications and helpful links

General Publications

• 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/nature13903. Epub 2014 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): December 26, 2019

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 20170206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No