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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03092648
• Other study ID #: NFEC-2016-187
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 22, 2017
• Last updated: March 22, 2017
• Start date: March 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guodong Hu, M.D.
• Email: huguodong123123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2019
• Est. primary completion date: December 30, 2018
• 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.);

• 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 ?-?);

• 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 cell
autologous bronchial basal cell transplantation

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Regend Therapeutics, Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)	One of the indicators for pulmonary function	1-6 months
Primary	Forced vital capacity (FVC)	One of the indicators for pulmonary function	1-6 months
Secondary	FEV1/FVC, MMF, MVV and DLCO	Other indicators for the pulmonary function	1-6 months
Secondary	6 minute walk test (6MWT)	Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases	1-6 months
Secondary	MMRC	Indicator to evaluate the level of dyspnea	1-6 months
Secondary	SGRQ	A questionnaire to assess life quality affected by the respiratory problems	1-6 months