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Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis

Bronchiectasis Clinical Trial

Official title:
Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis

Clinical Trial Summary

Bronchiectasis is a disease resulted from progressive destruction of bronchi with no effective drug for its treatment. In this study, we intends to carry out a randomized, single-blinded, controlled pilot clinical trial at 1/2 phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue via bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after airway clearance. The investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, 6 minute walk distance (6MWD), the distance-saturation product (DSP), St. George's Respiratory Questionnaire (SGRQ), FACED scoring, bronchiectasis severity index (BSI) , and high-resolution computed tomography (HRCT) at week 4, week 12, and week 24 after cell transplantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03655808
Study type Interventional
Source Ruijin Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 21, 2020
Completion date May 17, 2023
View Details
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