Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy

NCT05638776 | Completed Phase 2

• 1 other identifier: REGEND001-COPD-201
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND001 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 cell therapy in treatment of chronic obstructive pulmonary disease with diffusion capacity defect.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline

  DLCO is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.

  Within 52 weeks after treatment

Secondary Outcomes (20)

• Change of the alveolar volume (VA) from baseline

  Winthin 52 weeks after treatment

• Change of images of lung by high resolution computed tomography (HR-CT) from baseline

  Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment

• Change of forced vital capacity (FVC) from baseline

  Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment

• Change of forced expiratory volume in one second (FEV1) from baseline

  Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment

• Change of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) from baseline

  Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment

Study Arms (2)

REGEND001 cell therapy

EXPERIMENTAL

REGEND001 cell therapy

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

REGEND001 cell therapy DRUG

Transplantation of the cell product

Placebo DRUG

Transplantation of Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 40 to 75 at the time of signing informed consent.
• Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
• The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is \< 70% after inhalation of bronchodilators.
• The diffusion function of carbon monoxide (DLCO) is ≥ 20% and \< 80% of the predicted value at screening.
• Tolerated to pulmonary function tests.
• Tolerated to bronchoscopy
• Voluntary to sign the informed consent, coordinated to finish the trial-related procedures and tests, and capable of recording or stating the change of disease condition in a relatively complete manner.

You may not qualify if:

• Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
• Subject positive in each of the tests containing treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at screening. But except the followings:
• Hepatitis B virus carriers (only HBsAg positive without any hepatitis symptom or sign, and all liver function tests present normal results or abnormal markers without clinical significance by the assessment of investigators);
• Cured hepatitis C patients (negative in HCV ribonucleic acid (RNA) test);
• Subject with assessed survival time of \< 1 year by investigators at screening;
• Subject with malignant tumors or a history of malignant tumors at screening;
• Subject with infections in lung or other sites, requiring intravenous drug treatment within a week prior to screening;
• Subject with more than 4 moderate-to-severe AECOPD, resulting in hospitalization within a year prior to screening;
• Subject with one or more pathogenetic or serologic findings of the novel coronavirus infection, or symptoms of suspected infection within 6 weeks prior to screening;
• Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks prior to screening;
• Subject who has taken prednisone tablets orally at a dose of ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks prior to screening;
• Subject with major lung diseases other than COPD by assessment of investigators at screening;
• Subject with severe systemic diseases other than lung within 6 months prior to screening and assessed to be inappropriate to participate in this trial by investigators;
• Subject with severe anemia or poorly controlled granulocyte deficiency, thrombocytopenia by assessment of investigators;
• Subject with abnormal coagulation and assessed to be negative for the safety of fiberoptic bronchoscopy operations at screening;

Sponsors & Collaborators

• Regend Therapeutics: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Southwest Hospital, China: collaborator
• Shanghai Zhongshan Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Shanghai East Hospital: collaborator
• Regend Therapeutics XLotus (Jiangxi) Co, Ltd.: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Xiangya Hospital of Central South University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (8)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 6, 2022
• Study Start: December 6, 2022
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)