REGEND001 Autologous Basal Layer Stem Cell Transplantation for Chronic Obstructive Pulmonary Disease (COPD): A Translational Application Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: P63+ lung progenitors.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological 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:
Primary outcome measures
- Change in DLCO from baseline. [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
Secondary outcome measures (3)
- Change in FEV1 from baseline. [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
- Change in FVC from baseline. [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
- Improvement in CAT score (symptoms, activity, and psychological status). [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
Eligibility criteria
Inclusion criteria
- Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);
- Post-bronchodilator FEV1/FVC <70%;
- DLCO ≥20% and <80% of predicted value.
Exclusion criteria
- Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);
- Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;
- Current or past history of malignancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine — Qionghai
- Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06946953 · 20250322