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Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis

Bronchial basal cells · Phase 1

Registry ID
NCT03655808
Phase
Phase 1
Status
Completed
Drug / intervention
Bronchial basal cells (BBCs)
Sponsor
Ruijin Hospital
Start
2020-06-21
Enrollment
37
Locations
1

About this trial

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.

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Medical disclaimer. This page summarizes public trial data for NCT03655808 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.