NCT07828353Not yet recruitingPhase 3
A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Regend Therapeutics
- Diseases
- COPD
- NCT number
- NCT07828353
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 102
- From Oct 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Current or previous history of malignancy;
- History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;
Other
- An assessed life expectancy of \<1 year;
- Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening;
Who the study is looking for
- 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;
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.