drugset / Trial / NCT03153800

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

NCT03153800 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-04-05
Primary completion
2021-04-04
Completion
2021-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bronchial basal cells Cell therapy — Other