Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Biological: Bronchial basal cell

• Registration Number: NCT03092648
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-01
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Last Update Submitted: 2017-03-22
• Study First Posted: 2017-03-28
• Last Update Posted: 2017-03-28
• Primary Completion: 2018-12-30
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchial basal cells	Bronchial basal cell	-

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1)	1-6 months	One of the indicators for pulmonary function
Forced vital capacity (FVC)	1-6 months	One of the indicators for pulmonary function

Secondary Outcome Measures

Name	Time	Method
FEV1/FVC, MMF, MVV and DLCO	1-6 months	Other indicators for the pulmonary function
6 minute walk test (6MWT)	1-6 months	Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
MMRC	1-6 months	Indicator to evaluate the level of dyspnea
SGRQ	1-6 months	A questionnaire to assess life quality affected by the respiratory problems

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China