Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
BIOLOGICALP63+ 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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTJiayang Yan
Outcome results
None listed