This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.
This is a two-stage Phase IIa, dose escalation followed by randomized, open-label, controlled with standard treatment, parallel-group study to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cell, UMSC01, as an add-on treatment in subjects with STEMI. Subjects should present typical ischemic chest pain within 12 hours after symptoms onset and are diagnosed acute STEMI. Subjects should have undergone standard-of-care for STEMI, the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy, and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms. This study aims to treat eligible subjects with UMSC01 as an add-on stem cell therapy along with standard-of-care for STEMI. The investigational product (IP), UMSC01, will be applied to subjects via intracoronary (IC) infusion on the 4th - 5th day after the onset of the heart attack, followed by intravenous (IV) infusion 2 days after the IC infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
UMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.
Standard-of-care for STEMI
China Medical University Hospital
Taichung, Taiwan
RECRUITINGIncidence of adverse event (AE) as presented by MedDRA coding system
AE incidences up to 1-month
Time frame: from Day 1 to 1-month follow-up period
Incidence of Serious adverse event (SAE) as presented by MedDRA coding system
SAE incidences up to 1-month
Time frame: from Day 1 to 1-month follow-up period
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
SUSAR incidences up to 1-month
Time frame: from Day 1 to 1-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Change in peak oxygen consumption (VO2) at the end of maximal exercise over the study period
Time frame: from Day 6 to 6-month follow-up period
Percentage of subject with cardiovascular hospitalizations or urgent care/ emergency room visits for heart failure/exacerbation of coronary artery disease (CAD)
The percentage of subject with cardiovascular hospitalizations or urgent care/ emergency room visits for heart failure/exacerbation of coronary artery disease (CAD) over the study period
Time frame: from Day 3 to 24-month follow-up period
Percentage of subject with major adverse cardiovascular events (MACE)
The percentage of subject with major adverse cardiovascular events (MACE), including death, recurrent acute myocardial infarction (AMI), stroke, and target vessel revascularization over the study period
Time frame: from Day 6 to 24-month follow-up period
Percentage of subject with ventricular tachycardia/ventricular fibrillation (VT/VF)
The percentage of subject with ventricular tachycardia/ventricular fibrillation (VT/VF) over the study period
Time frame: from Day 6 to 24-month follow-up period
New York Heart Association (NYHA) Classification
Changes in New York Heart Association (NYHA) classification over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables regional left ventricular wall-motion score index (RWMSI) in total score over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular end-systolic volume (LVESV) in mL over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular end-diastolic volume (LVEDV) in mL over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular ejection fraction (LVEF) in % over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables stroke volume (SV) in mL over the study period
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables LV fractional shortening in % over the study period
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in peak oxygen consumption (VO2) at the end of maximal exercise over the study period
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in exercise time (min) at the end of maximal exercise over the study period
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in ventilatory efficiency/carbon dioxide production (VE/VCO2) slope at the end of maximal exercise over the study period
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in peak heart rate at the end of maximal exercise over the study period
Time frame: from Day 6 to 24-month follow-up period
6-minute walk distance (6MWD)
Changes in 6-minute walk distance (6MWD) over the study period
Time frame: from Day 6 to 24-month follow-up period
Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Changes in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) over the study period
Time frame: from Day 6 to 24-month follow-up period
cardiac enzyme levels
Changes in cardiac enzyme levels including creatinine kinase (CK), creatinine kinase-MB (CK-MB), and troponin I over the study period
Time frame: from Day 6 to 1-month follow-up period
Pulmonary function test
Changes in forced expiratory volume (FEV1) will be tested by Spirometry over the study period
Time frame: from Day 6 to 24-month follow-up period
Incidence of adverse event (AE) as presented by MedDRA coding system
AE incidences over the study period
Time frame: from Day 3 to 24-month follow-up period
Incidence of serious adverse event (SAE) as presented by MedDRA coding system
SAE incidences over the study period
Time frame: from Day 3 to 24-month follow-up period
Incidence of suspected and unexpected serious adverse reactions (SUSAR) s presented by MedDRA coding system
Suspected and unexpected serious adverse reactions (SUSAR) incidences over the study period
Time frame: from Day 3 to 24-month follow-up period
12-lead ECG Test
Changes in 12-lead electrocardiogram (ECG) parameters in PR, QRS, QT, QTc, and RR intervals over the study period
Time frame: from Day 1 to 24-month follow-up period
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