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

Regend Therapeutics

Status and phase

Unknown

Early Phase 1

Conditions

Chronic Respiratory Disease

Treatments

Biological: bronchial basal cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03153800

2017042

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 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 investigators.