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NCT Number: NCT07828353

A Clinical Study of REGEND001 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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

Placebo

Biological

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.

REGEND001

Biological

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.

Primary outcomes

  1. Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）

    Time frame: Week 52 after treatment

    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.

Secondary outcomes

  1. Change from baseline in COPD Assessment Test (CAT) score

    Time frame: Week 12, 24 and 52 after treatment

    The change from baseline in CAT score is defined as the difference between the CAT score at baseline and the CAT score measured at the specified post-treatment assessment time point.

  2. Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score

    Time frame: Week 12, 24 and 52 after treatment

    Minimal clinically important difference for CAT is recognized as 2 points.

  3. Change from baseline in DLCO

    Time frame: Week 12, 24 and 52 after treatment

    DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).

  4. Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO

    Time frame: Week 12, 24 and 52 after treatment

    Minimal clinically important difference (MCID) of DLCO is recognized as 11%.

  5. Change from baseline in alveolar volume (VA)

    Time frame: Week 12, 24 and 52 after treatment

    VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).

  6. Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator

    Time frame: Week 12, 24 and 52 after treatment

    FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).

  7. Change from baseline in 6-minute walk distance (6MWD)

    Time frame: Week 12, 24 and 52 after treatment

    6MWD is assessed by the measured value and corresponding area under curve

  8. Proportion of subjects with a ≥30-meter change from baseline in 6MWD

    Time frame: Week 12, 24 and 52 after treatment

    Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.

  9. Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score

    Time frame: Week 12, 24 and 52 after treatment

    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.

  10. Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score

    Time frame: Week 12, 24 and 52 after treatment

    Minimal clinically important difference for SGRQ is recognized as 4 points.

  11. Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics

    Time frame: Week 52 after treatment

    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.

  12. Change from baseline in arterial blood gas parameters

    Time frame: Week 52 after treatment

    The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.

  13. Change from baseline in HRCT images

    Time frame: Week 52 after treatment

    HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).

  14. Adverse Event

    Time frame: Hour 24, Week 12, 24 and 52 after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyue Li, Professor and Chief Physician

CONTACT

[email protected]

86-20-83062114

Sponsors and collaborators

Lead sponsor

Regend Therapeutics

Industry

Registry information

Official study title

A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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