NCT03153800

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Regend Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Respiratory Disease

Interventions

Type	Name	Description
BIOLOGICAL	bronchial basal cells	Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.

Timeline

• Start date: 2017-04-05
• Primary completion: 2021-04-04
• Completion: 2021-10-04
• First posted: 2017-05-15
• Last updated: 2019-09-18

Locations

1 site across 1 country: China