NCT06946953

Airway Basal Stem Cell Therapy in Chronic Obstructive Pulmonary Disease (COPD)

Translational Application of Airway Basal Stem Cell Therapy in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: China