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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03092648
Other study ID # NFEC-2016-187
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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