COPD (Chronic Obstructive Pulmonary Disease)Phase 3NCT07828353
A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing REGEND001 in people with COPD (Chronic Obstructive Pulmonary Disease), run by Regend Therapeutics at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- REGEND001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
- Current or previous history of malignancy;
- An assessed life expectancy of <1 year;
- Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening;
- History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;
- Diagnosis of pneumonia within 3 months prior to screening;
- Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: 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.
- Being tested
- Placebo, REGEND001
- Keywords
- airway basal stem cells, regenerative medicine, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of placebo via bronchoscopy and 1 year of follow-up.
REGEND001Biological
Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of REGEND001 via bronchoscopy and 1 year of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants randomized to the Placebo Comparator arm will receive a single administration of placebo. Receives: Biological: Placebo |
| REGEND001 | Experimental | Participants randomized to the experimental arm will receive a single administration of REGEND001. Receives: Biological: REGEND001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
The change from baseline in measured DLCO is defined as the difference between the absolute measured DLCO value at baseline and that measured at the assessment time point after treatment.
Measured: Week 52 after treatment
Secondary outcomes (14)
Change from baseline in COPD Assessment Test (CAT) score
The COPD Assessment Test (CAT) is an 8-item questionnaire used to assess the impact of COPD on health status. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD and worse health status. Change from baseline is calculated as the post-treatment CAT score minus the baseline CAT score.
Measured: Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score
Minimal clinically important difference for CAT is recognized as 2 points.
Measured: Week 12, 24 and 52 after treatment
Change from baseline in DLCO
DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).
Measured: Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO
Minimal clinically important difference (MCID) of DLCO is recognized as 11%.
Measured: Week 12, 24 and 52 after treatment
Change from baseline in alveolar volume (VA)
VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).
Measured: Week 12, 24 and 52 after treatment
Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator
FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).
Measured: Week 12, 24 and 52 after treatment
Change from baseline in 6-minute walk distance (6MWD)
6MWD is assessed by the measured value and corresponding area under curve
Measured: Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥30-meter change from baseline in 6MWD
Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.
Measured: Week 12, 24 and 52 after treatment
Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score
The St. George's Respiratory Questionnaire for COPD (SGRQ-C) is a validated disease-specific patient-reported outcome measure used to assess the impact of COPD on patients' health status and quality of life. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.
Measured: Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score
Minimal clinically important difference for SGRQ is recognized as 4 points.
Measured: Week 12, 24 and 52 after treatment
Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics
The annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics, represents the adjusted frequency of acute exacerbations of COPD over the assessment period.
Measured: Week 52 after treatment
Change from baseline in arterial blood gas parameters
The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.
Measured: Week 52 after treatment
Change from baseline in HRCT images
HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).
Measured: Week 52 after treatment
Adverse Event
An adverse event (AE) is any untoward medical occurrence in a subject who has received a study intervention, regardless of whether or not it is considered related to the intervention.
Measured: Hour 24, Week 12, 24 and 52 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828353
- Sponsor's protocol ID
- REGEND001-COPD-251
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No