A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect

Regend Therapeutics8 sites in 1 country58 target enrollmentDecember 6, 2022

ConditionsChronic Obstructive Pulmonary Disease

InterventionsPlacebo

DrugsREGEND001 cell therapy Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Regend Therapeutics
Enrollment: 58
Locations: 8
Primary Endpoint: Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2022

End Date

July 9, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Regend Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Arms & Interventions

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Within 52 weeks after treatment

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

Secondary Outcomes

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)
Change of the diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Change of 6-minute-walk test (6MWT) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Change of modified medical research council (mMRC) dyspnea scale from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Change of chronic obstructive pulmonary disease Assessment Test (CAT) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Annual frequency of exacerbations(1 year after treatment)
Symptoms, physical examination(Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
12-lead ECG(4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Blood routine(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Urine routine(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Blood biochemistry(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Function of blood clotting(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Carcinoembryonic antigen (CEA)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Neuron-specific enolase (NSE)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Cytokeratin-19-fragment (CYFRA21-1)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
Squamous cell carcinoma antigen (SCC)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)