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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Biological: P63+ lung progenitors

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiayang Yan; Phone Number: +8619821839207; Email: yjy19960816@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: COPD patients

Biological: P63+ lung progenitors; 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.; 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.; Post-Treatment Follow-Up: Patients are advised to return for examination and evaluation at 4 and 24 weeks post-treatment.; Other Names: Lung progenitors; Airway basal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 weeks post treatment, 24 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	CAT, COPD Assessment Test. Score range: 0 to 40. Higher scores indicate a worse outcome.	Baseline, 4 weeks post treatment, 24 weeks post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and serious adverse events.	Safety Evaluation	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 20250322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No