Acute Myocardial Infarction
Conditions
Keywords
Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intravenous Mesenchymal Stem Cells, Intracoronary Mesenechymal Stem Cells
Brief summary
The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.
Interventions
BIOLOGICALMesenchymal Stem Cells
The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction * Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of \< 45% by echocardiography. * Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf, * Willingness to attend all scheduled safety follow-up visits * Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF \<45).
Exclusion criteria
* Hemodynamic instability as demonstrated by any of the following, * Requirement of intra-aortic balloon pump of left ventricular assist device, * Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg, * Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb \< 10 g/dL, WBC \< 4 or \> 11x109/L, or platelets \< 100x109/L), kidney failure (creatinine level \> 2.5 mg/dL, or creatinine clearance \< 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse, * Prosthetic valves, * Hypertrophic or restrictive cardiomyopathy, * Women of child-bearing potential, * Inability to comply with the protocol, * Currently using implantable electronic defibrillator or pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) endpoints of mortality | 2 weeks after stem cell | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. |
| Re-infarction | 2 weeks after stem cell | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. |
| Target vessel revascularization (TVR) | 2 weeks after stem cell | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. |
| Heart failure hospitalization | 2 weeks after stem cell | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac MRI | 6 months after stem cell | a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size. |
| Laboratory Assessment | 12 months after stem cell | Haematology, Serum Chemistry, Cardiac Biomarker |
| Echocardiography | 6 months after stem cell | Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography. |
| Electrocardiography (ECG) | 3 months after stem cell | to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts |
| Wellness Parameter | 6 months after stem cell | hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen |
Countries
Indonesia
Outcome results
None listed