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.
Male or female subjects are aged ≥ 20, < 76 years old on date of consent
Presence of typical ischemic chest pain within 12 hours after symptoms onset and clinical diagnosis of acute STEMI according to the 2013 American College of Cardiology (ACC) Foundation/ American Heart Association (AHA) guideline for the Management of STEMI
Has 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
Received successful acute reperfusion therapy (residual stenosis visually < 50% and thrombolysis in myocardial infarction flow ≥ 2) with placement of an intracoronary stent and having a patent infarct-related artery suitable for cell infusion to the target area of abnormal wall motion following myocardial infarction
With cardiogenic shock (defined as systolic blood pressure <80mmHg requiring vasopressors, intra-aortic balloon pump(IABP) or extracorporeal membrane oxygenation (ECMO)
Presence of severe aortic stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for themanagement of patients with valvular heart disease
Presence of severe mitral stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for the management of patients with valvular heart disease
With a need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery
Parallel
Allogeneic umbilical cord mesenchymal stem cells
Biological/VaccineUMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.
Control group
Other interventionStandard-of-care for STEMI
Incidence of adverse event (AE) as presented by MedDRA coding system
AE incidences up to 1-month
Incidence of Serious adverse event (SAE) as presented by MedDRA coding system
SAE incidences up to 1-month
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
SUSAR incidences up to 1-month
Cardiopulmonary Exercise Testing (CPET)
Change in peak oxygen consumption (VO2) at the end of maximal exercise over the study 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
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
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
New York Heart Association (NYHA) Classification
Changes in New York Heart Association (NYHA) classification over the study period
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