NCT07477600

cfMSC Stem Cell Therapy Targeting COPD

Clonal Fetal Mesenchymal Stem Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are to evaluate the safety and efficacy of infusion of fully characterized clonally derived fetal mesenchymal stem cells (cfMSCs) for the control of severe symptoms associated with moderate to severe chronic obstructive pulmonary disease.

Detailed description

Chronic obstructive pulmonary disease (COPD) is a chronic airway inflammatory disease characterized by persistent airflow limitation, with high morbidity, disability and mortality worldwide. Traditional therapeutic methods such as bronchodilators and anti-inflammatory drugs can only relieve clinical symptoms, delay disease progression, but cannot repair the damaged alveolar and airway tissue structure, so the long-term prognosis is poor. Clonal fetal mesenchymal stem cells (cfMSCs) are isolated and clonally characterized fetal tissue-derived MSCs with demonstrated low allogeneity and multi-directional differentiation potential, which may modulate lung stromal cells, alveolar epithelial cells and airway epithelial cells to repair the damaged lung tissues and facilitate the regeneration of alveolar and airway structure, thus improving the lung ventilation as well as gas exchange function of the COPD patients. In addition, cfMSCs may secrete a variety of anti-inflammatory factors, growth factors and exosomes to inhibit the excessive inflammatory response in the lung tissue of COPD patients, improve the local microcirculation, and lay a foundation for the repair of damaged lung tissues. This study aims to evaluate the safety, tolerability and preliminary efficacy of fully characterized cfMSCs in patients with moderate to severe COPD whose prior treatment has been ineffective. The research will provide a new clinical strategy for treating COPD and determine the optimal cell dosage, administration route and long-term therapeutic effect of the stem cell therapy, and open up a new path for the regenerative repair of lung damage caused by chronic respiratory diseases.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
BIOLOGICAL	clonal fetal MSCs	cfMSCs to treat Chronic Obstructive Pulmonary Disease

Timeline

• Start date: 2026-03-10
• Primary completion: 2029-03-31
• Completion: 2030-04-30
• First posted: 2026-03-17
• Last updated: 2026-03-25

Locations

1 site across 1 country: China