This study is a first-in-human assessment of safety of using UCMSC in patients with AMI via a combination of IC and IV stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IC and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.
Cardiovascular disease is the leading cause of death in the developed world, with global deaths due to coronary artery disease estimated to increase from 7.3 million in 2008 to 25 million by 2020 WHO, 2011. The leading symptom that initiates the diagnostic and therapeutic cascade in patients with suspected acute coronary syndromes (ACS) is chest pain. Most patients will ultimately develop an ST elevation myocardial infarction (STEMI). The mainstay of treatment in these patients is immediate reperfusion by primary angioplasty or fibrinolytic therapy. Basically, STEMI comprises approximately 25% to 40% of myocardial infarction (MI) presentations. Acute STEMI is a major cause of morbidity, mortality, and disability. This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for AMI and stroke. The rats with coronary artery ligation receiving intravenous injection of UMSC01 showed significantly improved cardiac function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.
China Medical University Hospital
Taichung, Non-US, Taiwan
Incidence of Treatment emergent adverse event (TEAE) as presented by MedDRA coding system
TEAE incidences over the study period
Time frame: from visit 2 to 12-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 visit 2 to 12-month follow-up period
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
SUSAR incidences over the study period
Time frame: from visit 2 to 12-month follow-up period
New York Heart Association (NYHA) Classification
The NYHA classification is used to grade the severity of functional limitations in a patient with heart failure with Class I=no limitations to Class IV=unable to carry on any physical activity without discomfort.
Time frame: 12 weeks
Incidence of major adverse cardiovascular events (MACE)
MACE are defined as death, recurrent MI, stroke, target vessel revascularization.
Time frame: from screen visit to 12-month follow-up period
Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Change of serum level of NT pro-BNP from baseline visit to subsequent visits will be summarized by descriptive statistics.
Time frame: 52 weeks
Pulmonary function test
The FEV1 will be tested by Spirometry and recorded.
Time frame: 52 weeks
Echocardiogram
Change of regional left ventricular wall motion score in total score from baseline visit to subsequent visits will be displayed by descriptive statistics
Time frame: 52 weeks
Echocardiogram
Change of LVESV in mL from baseline visit to subsequent visits will be displayed by descriptive statistics
Time frame: 52 weeks
Echocardiogram
Change of LVEDV in mL from baseline visit to subsequent visits will be displayed by descriptive statistics
Time frame: 52 weeks
Echocardiogram
Change of LV fractional shortening in % from baseline visit to subsequent visits will be displayed by descriptive statistics
Time frame: 52 weeks
Echocardiogram
Change of LVEF in % from baseline visit to subsequent visits will be displayed by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of LVEF in % from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of regional left ventricular wall motion score in total score from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of LVESV in mL from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of LVEDV in mL from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of scar volume in % from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
Cardiac MRI (cMRI) for baseline and efficacy evaluation
Change of myocardial fibrosis quantification in % from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: 52 weeks
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