Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
NCT Number: NCT06491043
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: UMC119-06-05
Sponsor: Meribank Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-11
Completion Date: 2027-12-30
Locations: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare, New Taipei City, 23561, Taiwan|Chang Gung Memorial Hospital, Linkou, Taoyuan City, 333, Taiwan

Summary:
This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.

Primary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.

2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results, From Baseline to Day 90]|Incidence of related TEAEs and serious adverse events (SAEs), Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.

2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results, through the study|Incidence of withdrawals due to adverse events (AEs), AE incidence, through the study|Change/shift from baseline in laboratory tests, laboratory tests, Baseline, 2 hours (h), Days 3, 7, 14, 28, 90|Change from baseline in vital signs, measure vital signs, Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90|shift from baseline in ECG results, ECG check, Baseline, 2 h, Day 14|Shift from baseline in physical examination results, physical examination, Baseline, 2 h, Days 3, 7, and 14
Secondary Outcome Measures: Mean change from baseline in forced vital capacity (FVC), Respiratory functions (FVC) 2.Mean change from baseline in forced expiratory volume in one second (FEV1) 3.Mean change from baseline in FEV1/FVC ratio 4.Mean change from baseline in 6-minute walk test (6-MWT) 5.Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score 6.Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale 7.Incidence, frequency, and severity of COPD exacerbations 8.Time to first COPD exacerbation 9.Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index 10.The number of times that rescue medication is used, Baseline, Days 28, 90, 180, 270, 360|Mean change from baseline in forced expiratory volume in one second (FEV1), Respiratory functions (FEV1), Baseline, Days 28, 90, 180, 270, 360|Mean change from baseline in FEV1/FVC ratio, Respiratory functions (FEV1/FVC), Baseline, Days 28, 90, 180, 270, 360|Mean change from baseline in 6-minute walk test, measure 6 minute walk distance, Baseline, Days 28, 90, 180, 270, 360|Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score, Georges Respiratory Questionnaire has scores range from 0 to 100, with higher scores indicating more limitations, Baseline, Days 28, 90, 180, 270, 360|Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale, mMRC dyspnea scale, Baseline, Days 28, 90, 180, 270, 360|Incidence, frequency, and severity of COPD exacerbations, assess severity of COPD, through the study|Time to first COPD exacerbation, assess severity and exacerbation, through the study|9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index, BODE index, baseline to Days 28, 90, 180, 270, 360|he number of times that rescue medication is used, times of rescue medication, through the study