drugset / Trial / NCT02722642

Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis

NCT02722642 ↗

NaSingle-groupOpen-labelTreatment

Summary

Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring the key indicator-- the CT imaging of dilated bronchi as well as four secondary indicators including the pulmonary function, laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.

Timeline

Start
2016-03
Primary completion
2020-06
Completion
2020-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bronchial basal cells Cell therapy 1e+06 cells/kg Other

Indications