Clinical trial NCT03092648: Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Regend Therapeutics
name: Tongji University
First posted: 2017-03-28
Enrollment: 20
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
Intervention model description: open, non-random, concurrent control
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial 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, cultured 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.);
* 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 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: Forced expiratory volume in one second (FEV1)
timeFrame: 1-6 months
measure: Forced vital capacity (FVC)
timeFrame: 1-6 months
Secondary outcomes:
measure: FEV1/FVC, MMF, MVV and DLCO
timeFrame: 1-6 months
measure: 6 minute walk test (6MWT)
timeFrame: 1-6 months
measure: MMRC
timeFrame: 1-6 months
measure: SGRQ
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Regend Therapeutics Co.Ltd
name: Wei Zuo, Ph. D.
role: STUDY_CHAIR
References: