Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Bronchial basal cells (BBCs); Bronchoscopic airway clearance treatment （B-ACT）
Intervention type(s): Biological; Procedure
Intervention description(s): 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.; 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).
Other intervention name(s): P63+ lung stem/progenitor cells; Airway basal cells; Lung stem/progenitor cells
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligibility patients were randomly assigned in a 1:1 ratio to receive either autologous cell transplantation therapy (cell treatment group) or bronchoscopic airway clearance treatment (B-ACT therapy, control group).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiectasis; Bronchial basal cells; Autologous transplantation