Clinical trial NCT06946953: Airway Basal Stem Cell Therapy in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Translational Application of Airway Basal Stem Cell Therapy in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in DLCO from baseline.
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Secondary outcomes:
measure: Change in FEV1 from baseline.
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Change in FVC from baseline.
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Improvement in CAT score (symptoms, activity, and psychological status).
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Other outcomes:
measure: Incidence of adverse events and serious adverse events.
timeFrame: Through study completion, an average of 6 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: