On September 8, 2026, at the European Respiratory Society International Congress (ERS Congress 2026) held in Barcelona, Spain, Professor Wei Zuo of Tongji University, Chief Scientist of Regend Therapeutics, delivered a congress presentation titled "Real-world study of autologous airway basal stem cell transplantation for COPD therapy," focusing on the clinical translation and real-world study progress of autologous airway basal stem cell therapy (REGEND001 lung regeneration therapy) for chronic obstructive pulmonary disease (COPD), and shared the latest real-world clinical data of REGEND001 lung regeneration therapy.

 

The world's first lung regeneration therapy

 

This real-world study was conducted based on real-world data from Ruijin Hainan Hospital on airway basal stem cell therapy for COPD from March 2025 to July 2026, aiming to evaluate the true safety and efficacy of this innovative regenerative medicine therapy in clinical practice. The study was jointly completed by Professor Zuo Wei's team at Tongji University School of Medicine and Professors Jieming Qu ,Min Zhou ,Wei Chen , and others at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.

 

Patients with COPD, especially those with emphysema, experience persistent destruction of alveolar structure and impaired gas exchange function. Existing treatments are mainly used to relieve airway obstruction and control inflammation, and lack effective regenerative repair approaches for already damaged lung tissue. In response to this unmet clinical need, Regend Therapeutics developed REGEND001 lung regeneration therapy, leveraging the regenerative potential of patients' own airway basal stem cells to explore the repair of damaged airway and alveolar structures.

 

At present, REGEND001 lung regeneration therapy has established a complete technical system covering airway tissue sampling, isolation and expansion of clonogenic basal stem cells, quality control, and autologous transplantation under bronchoscopy. A previously completed randomized, placebo-controlled Phase II clinical study showed that after treatment with REGEND001 lung regeneration therapy, multiple indicators in COPD patients, including lung diffusion capacity (DLCO), alveolar volume (VA), and CAT score, demonstrated clinical benefits, and imaging evidence of improvement in lung structure in areas reachable by cells was observed.

 

 

Based on the efficacy and safety evidence accumulated from prior clinical studies in COPD, idiopathic pulmonary fibrosis (IPF), and other conditions, the REGEND001 lung regeneration therapy technology was implemented and applied at Ruijin Hospital Hainan Hospital in the Hainan Boao Medical Pilot Zone in early 2025. As a national-level medical innovation pilot zone, Lecheng provides an important platform for the standardized clinical application of innovative therapies and the accumulation of real-world evidence, and has also enabled REGEND001 lung regeneration therapy to advance further from clinical trials to real-world application.

 

Excellent efficacy data at six months

 

As of July 22, 2026, 143 patients with COPD had received REGEND001 lung regeneration therapy, of whom 47 entered the 24-week real-world efficacy analysis. The latest results showed that after 24 weeks of treatment, patients' lung diffusion capacity (DLCO) increased by an average of 0.481 mmol/min/kPa from baseline (P=0.041), suggesting improvement in pulmonary gas exchange capacity; meanwhile, patients' CAT scores decreased by an average of 2.723 points from baseline (P=0.017), suggesting significant improvement in respiratory symptoms and quality of life.

 

 

In terms of safety, no serious adverse events related to cell therapy were reported in this real-world study. revious clinical studies and long-term follow-up likewise did not observe delayed-onset treatment-related serious safety signals. Notably, the earliest 2 COPD patients in the filed clinical study (IIT) have now both been followed for more than 10 years, with favorable long-term safety; among them, 1 patient's lung function still showed a trend of continuous improvement during long-term follow-up, providing important clinical observational evidence for the long-term safety and potential durable benefits of REGEND001 lung regeneration therapy.

 

Highly recognized by global experts

 

This study also drew the attention of international peers. Professor Bernardino Alcázar-Navarrete, President-elect of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), highly praised the clinical significance of the study during on-site exchanges, stating that this work provides an important new direction for regenerative treatment of respiratory diseases and is expected to further advance the treatment of respiratory diseases into the era of regenerative medicine. Of particular note, the efficacy trends observed in this real-world study are highly consistent with the results of the previous randomized, placebo-controlled Phase II clinical study, further forming mutually corroborating evidence between clinical trials and real-world studies, and also providing important support for the subsequent clinical translation of REGEND001 lung regeneration therapy.