About this trial
This study will test the hypothesis intracoronary administration of OmniMSC-AMI (allogenic bone marrow-derived mesenchymal stem cells) just after finishing the primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) patients without cardiogenic shock is safe and may provide benefit on improving left ventricular ejection fraction (LVEF) during clinical follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patents, with age ≤20 or ≤80 years old.
Chest pain onset.
12-lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.
TnT-I elevation.
Disqualifiers
Age < 20 or >80 years old.
History of
Malignancy.
Sepsis (abnormal WBC count elevation).
Trial design
Sequential
Treatments tested in this trial
OmniMSC-AMI
Biological/Vaccine10 anterior wall STEMI patients without cardiogenic shock will be enrolled into low dose group 1 (1.5 x 10\^7 OmniMSC-AMI, n=5) and then high dose group 2 (3.0 x 10\^7 OmniMSC-AMI, n=5).
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of adverse events occurring in given time frame shall be reported to evaluate overall safety.
Secondary outcomes
Heart function after AMI
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Heart function after treatment
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Sponsors and contacts
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