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.
Patients with chronic obstructive pulmonary disease (COPD) are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators and corticosteroids. Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function, meaning it gradually gets worse over time. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells are proposed as a novel therapy with potential in treatment of COPD. This clinical trial is a phase II study. It is a randomized, placebo-controlled, double-blind study. Eligible subjects will be randomized to one of the three groups: placebo control, low-dose UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment. Subjects will receive a single-dose IV infusion to evaluate the efficacy and long-term safety of UMC119-06-05 with moderate to severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Human Umbilical Cord Derived-Mesenchymal Stem Cells
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan
RECRUITINGChang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan
RECRUITINGIncidence 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
Time frame: 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
Time frame: through the study
Incidence of withdrawals due to adverse events (AEs)
AE incidence
Time frame: through the study
Change/shift from baseline in laboratory tests
laboratory tests
Time frame: Baseline, 2 hours (h), Days 3, 7, 14, 28, 90
Change from baseline in vital signs
measure vital signs
Time frame: Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90
shift from baseline in ECG results
ECG check
Time frame: Baseline, 2 h, Day 14
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Shift from baseline in physical examination results
physical examination
Time frame: Baseline, 2 h, Days 3, 7, and 14
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
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in forced expiratory volume in one second (FEV1)
Respiratory functions (FEV1)
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in FEV1/FVC ratio
Respiratory functions (FEV1/FVC)
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in 6-minute walk test
measure 6 minute walk distance
Time frame: 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
Time frame: Baseline, Days 28, 90, 180, 270, 360
Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale
mMRC dyspnea scale
Time frame: Baseline, Days 28, 90, 180, 270, 360
Incidence, frequency, and severity of COPD exacerbations
assess severity of COPD
Time frame: through the study
Time to first COPD exacerbation
assess severity and exacerbation
Time frame: through the study
9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index
BODE index
Time frame: baseline to Days 28, 90, 180, 270, 360
he number of times that rescue medication is used
times of rescue medication
Time frame: through the study