Clinical trial NCT03188627: Autologous Bronchial Basal Cell Transplantation for Treatment of COPD
Official title: A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Regend Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Southwest Hospital, China
name: Tongji University
First posted: 2017-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Indicators for safety
timeFrame: 1-6 months
measure: Diffusion capacity of CO (DLCO)
timeFrame: 1-6 months
Secondary outcomes:
measure: The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
timeFrame: 1-6 months
measure: Maximum mid-expiratory flow (MMF)
timeFrame: 1-6 months
measure: Maximum voluntary ventilation (MVV)
timeFrame: 1-6 months
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 1-6 months
measure: 6-minute-walk test (6MWT)
timeFrame: 1-6 months
measure: Modified medical research council (MMRC) chronic dyspnea scale
timeFrame: 1-6 months
measure: St. George's respiratory questionnaire (SGRQ) scale
timeFrame: 1-6 months
measure: Imaging of lung by high resolution computed tomography (HR-CT)
timeFrame: 1-6 months
measure: Forced vital capacity (FVC)
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
state: Chongqing
Study officials:
References:
citation: 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.