A Phase 1/2 interventional study of P63+ lung progenitors in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Ruijin Hospital. Recruiting at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Ruijin Hospital · Phase 1/2, Interventional, and Treatment
This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous bronchial basal cell therapy, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic respiratory condition characterized by persistent airflow limitation and impaired lung function, leading to significant morbidity and mortality worldwide. Current treatments primarily focus on symptom management and have limited impact on disease progression or survival. This study proposes a novel approach using autologous bronchial basal cells, which have demonstrated the potential to repair damaged lung tissue and improve lung function in preclinical studies. The therapy involves the collection of bronchial basal cells via bronchial brushing, followed by their expansion and reintroduction into the patient's lungs via bronchoscopic infusion. The primary objective is to assess the improvement in lung diffusion capacity (DLCO), with secondary endpoints including changes in lung ventilation function (FEV1, FVC) and quality of life (CAT score). The study will also monitor safety, including the incidence of adverse events. Eligible participants are COPD patients aged 40-80 with moderate to severe disease. The trial includes a screening phase, cell collection, transplantation, and follow-up assessments at 4 and 24 weeks post-treatment. This study represents a promising advancement in regenerative medicine for COPD, offering a potential therapeutic option that addresses the underlying structural damage in the lungs.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: P63+ lung progenitors
1. Patient Screening and Cell Collection: Eligible patients will undergo sample collection at the study center or authorized tertiary hospitals. The operator will collect samples via bronchial brushing from three healthy segments of the patient's 3-5 level bronchi. The samples will be transported to a cooperative production facility for isolation and preparation. The cell preparation cycle is approximately 4-8 weeks. Patients will bear the costs of this process. 2. Transplantation Therapy: Transplantation therapy will be conducted at Ruijin Hainan Hospital. The cell preparation will be administered via fiberoptic bronchoscopy to each lung segment, with one dose per patient. After infusion, patients are advised to remain hospitalized for 24-48 hours for observation. 3. Post-Treatment Follow-Up: Patients are advised to return for examination and evaluation at 4 and 24 weeks post-treatment.
Also known as: Lung progenitors, Airway basal stem cells
Change in DLCO from baseline.
The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Change in FEV1 from baseline.
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Change in FVC from baseline.
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Improvement in CAT score (symptoms, activity, and psychological status).
CAT, COPD Assessment Test. Score range: 0 to 40. Higher scores indicate a worse outcome.
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Incidence of adverse events and serious adverse events.
Safety Evaluation
Time frame: Through study completion, an average of 6 months
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Pulmonary Disease, Chronic Obstructive→
Ruijin Hospital