REGEND001 Cell Therapy for Chronic Obstructive Pulmonary Disease With Emphysema
Tests REGEND001 stem cell therapy against placebo in people with COPD and emphysema.
Plain-language title generated from the registry record
Registry title: A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT07828353, who can take part
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regend Therapeutics
- Trial code
- NCT07828353
- Record updated
- 24 September 2026
- Original description
Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.Read full original descriptionShow less
A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.
Inclusion: Male or female, aged 40-75 years；; Diagnosed with COPD; Post-bronchodilator FEV1/FVC <0.7; Emphysematous lesions demonstrated by HRCT; Hemoglobin-corrected DLCO%predicted ≥20% and <70%; Post-bronchodilator FEV1%predicted ≤80%; COPD Assessment Test (CAT) score ≥3.
Exclusion: History of ≥2 COPD exacerbations leading to hospitalization within 1 year prior to screening, or a COPD exacerbation leading to hospitalization within 2 months prior to screening; Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening; Diagnosis of pneumonia within 3 months prior to screening; Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet therapy, who are unable to discontinue such medications for at least 1 week prior to cell collection and cell infusion; Current or previous history of malignancy; History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening; An assessed life expectancy of <1 year; Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening.