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

Phase 1

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Biological: P63+ lung progenitors

• Registration Number: NCT06946953
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-22
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-19
• Last Update Submitted: 2025-04-19
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-05-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);
2. Post-bronchodilator FEV1/FVC <70%;
3. DLCO ≥20% and <80% of predicted value.

Exclusion Criteria

1. Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);
2. Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;
3. Current or past history of malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD patients	P63+ lung progenitors	-

Primary Outcome Measures

Name	Time	Method
Change in DLCO from baseline.	Baseline, 4 weeks post treatment, 24 weeks post treatment	The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.

Secondary Outcome Measures

Name	Time	Method
Change in FEV1 from baseline.	Baseline, 4 weeks post treatment, 24 weeks post treatment
Change in FVC from baseline.	Baseline, 4 weeks post treatment, 24 weeks post treatment
Improvement in CAT score (symptoms, activity, and psychological status).	Baseline, 4 weeks post treatment, 24 weeks post treatment	CAT, COPD Assessment Test. Score range: 0 to 40. Higher scores indicate a worse outcome.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China