A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

September 14, 2026 updated by: Regend Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shiyue Li, Professor and Chief Physician
  • Phone Number: 86-20-83062114
  • Email: lishiyue@188.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.
Biological: Placebo
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.
Experimental: REGEND001
Participants randomized to the experimental arm will receive a single administration of REGEND001.
Biological: REGEND001
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 52 after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 12, 24 and 52 after treatment
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.
Week 12, 24 and 52 after treatment
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).
Week 12, 24 and 52 after treatment
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%.
Week 12, 24 and 52 after treatment
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).
Week 12, 24 and 52 after treatment
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).
Week 12, 24 and 52 after treatment
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
Week 12, 24 and 52 after treatment
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.
Week 12, 24 and 52 after treatment
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.
Week 12, 24 and 52 after treatment
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.
Week 12, 24 and 52 after treatment
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.
Week 52 after treatment
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.
Week 52 after treatment
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).
Week 52 after treatment
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.
Hour 24, Week 12, 24 and 52 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regend Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REGEND001-COPD-251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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