Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF

Chronic Respiratory Disease Clinical Trial

Official title:

Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153800
• Other study ID #: 2017042
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 5, 2017
• Est. completion date: October 4, 2021

Study information

• Verified date: September 2019
• Source: Regend Therapeutics
• Contact: Wei Zuo, Ph. D.
• Phone: 086-400-882-1090
• Email: zuow[@]regend.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, the safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 4, 2021
• Est. primary completion date: April 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with COPD, BE or PF according to the guideline;

• Clinically stable for more than 4 weeks;

• Tolerant to fiberoptic bronchoscopy test;

• 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 investigators.

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Biological:
• bronchial basal cells
Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.

Locations

Country	Name	City	State
China	The First Affiliated Hopsital of Soochow University	Suzhou	Jiang Su

Sponsors (2)

Lead Sponsor	Collaborator
Regend Therapeutics	The First Affiliated Hospital of Soochow 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 in pulmonary function test, a marker to assess airway obstruction	1-6 months
Primary	Diffusion capacity of CO (DLCO)	One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood	1-6 months
Secondary	The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)	One of the indicators in pulmonary function test, representing the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity	1-6 months
Secondary	Maximum mid-expiratory flow (MMF)	One of the indicators in pulmonary function test, standing for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second	1-6 months
Secondary	Maximum voluntary ventilation (MVV)	One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute	1-6 months
Secondary	Forced vital capacity (FVC)	One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation	1-6 months
Secondary	6-minute-walk test (6MWT)	An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases	1-6 months
Secondary	Modified medical research council (MMRC) chronic dyspnea scale	An indicator to evaluate the level of dyspnea	1-6 months
Secondary	St. George's respiratory questionnaire (SGRQ) scale	A questionnaire to assess life quality affected by the respiratory problems	1-6 months
Secondary	Imaging of lung by high resolution computed tomography (HR-CT)	HR-CT images of lung will be analyzed to indicate the pulmonary structure.	1-6 months

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