China-based Regend Therapeutics has opened the first Phase III study of pulmovinci, a first-in-class autologous airway basal stem cell therapy for chronic obstructive pulmonary disease (COPD) with emphysema, in a 102-patient, randomised, multicentre, double-blind, placebo-controlled trial with the primary endpoint of change in diffusing capacity of the lung for carbon monoxide at week 52.

Pulmovinci harvests healthy bronchial basal stem cells from the patient’s own airway, expands clonal progenitor cells under quality controls, and returns them by bronchoscopy to repair damaged airway and lung tissue, offering a regenerative alternative to inhalers, bronchodilators and anti-inflammatory maintenance therapy that do not reverse structural lung decline.

Real-world and investigator-initiated data underpin the move: 47 treated patients showed a 0.481 mmol/min/kPa rise in DLCO (p=0.041) and a 2.723-point drop in CAT score (p=0.017) at 24 weeks, with imaging evidence of structural improvement in cell-reachable lung regions and no cell-therapy-related serious adverse events, while the first two IIT patients have now passed 10 years of follow-up with one still showing progressive lung-function gain.