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

NCT ID: NCT06946953

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2029-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPD patients

Group Type: EXPERIMENTAL

P63+ lung progenitors

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Lung progenitors; Airway basal stem cells

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jieming QU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jiayang Yan

Role: CONTACT

yjy19960816@163.com

+8619821839207

Other Identifiers

20250322

Identifier Type: -

Identifier Source: org_study_id