Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 21, 2020

Primary Completion Date

May 17, 2023

Study Completion Date

May 17, 2023

Conditions
Bronchiectasis
Interventions
BIOLOGICAL

Bronchial basal cells (BBCs)

Airway epithelial cells were collected in patients of the cell treatment group by a disposable 2-mm brush in order to obtain BBCs. The obtained tissue were washed and enzymatically digested to form a single-cell suspension, which was then cultured under R-Clone system, a patented technique of Regend Therapeutics, Ltd.. For patients in the cell treatment group, on the basis of B-ACT therapy, they were also received autologous BBCs transplantation. Cell suspension was diluted with normal saline. Fibrotic bronchoscopy was guided into the lobular or segmental airways and cells were instilled into lobes.

PROCEDURE

Bronchoscopic airway clearance treatment (B-ACT)

The bronchoscopy was performed by board-certified respiratory physicians of Ruijin Hospital using a flexible fiber-optic bronchoscope. B-ACT therapy was performed on all patients in both groups according to the protocol. In brief, continuous suction was performed with the sputum aspirator from the trachea to the subsegmental during the entering of bronchoscope to remove the visible secretions from entire respiratory tract, and then operators used normal saline to collect lavage fluid (the volume various depending on the operator's judgement).

Trial Locations (1)

200025

Ruijin Hospital Shanghai JiaoTong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Regend Therapeutics

INDUSTRY

lead

Ruijin Hospital

OTHER

NCT03655808 - Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis | Biotech Hunter | Biotech Hunter