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| Name | Class |
|---|---|
| PT. Prodia Stem Cell Indonesia | INDUSTRY |
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The goal of this clinical trial is to learn about the effectiveness of Umbilical Cord Mesenchymal Stem Cell (UC MSC) therapy in patients with STEMI against infarct myocardial size reduction and prevent the incidence of heart failure in the future
Participants who have already done Primary Percutaneous Coronary Intervention (PCI) will be informed about the procedure and risk of this clinical trial. After written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get UC MSC transplantation) and control group. All participants will be check for their biochemical blood analysis: Interleukin-10 (IL-10), Vascular Endothelial Growth Factor (VEGF), Galectin-3, GATA Binding Protein-4 (GATA-4), and Beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (LVEF) through Cardiac MRI (7-10 days after Primary PCI and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/MACE (every month). The result will be access after 6 months follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSC | Experimental | Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation |
|
| Control | No Intervention | Patient assigned in control group doesn't get Umbilical Cord Mesenchymal Stem Cell transplantation. However, they will be fully treated based on European Society of Cardiology (ESC) guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cell transplantation | Biological | 50 million UC MSC will be transplanted 10-15 days after primary PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarct size change | Myocardial infarct size change in percentage measure with Cardiac MRI 7-10 days after primary PCI to 6 months after UC-MSC transplantation. The method used by measuring the area of infarction in a series of slices and multiplying the area times the slice thickness to determine a volume. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) with Echocardiography | Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation | 6 months |
| Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dede Moeswir | Contact | +62 81287364648 | dedemoeswir21@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dede Moeswir | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30029992 | Background | Terashvili M, Bosnjak ZJ. Stem Cell Therapies in Cardiovascular Disease. J Cardiothorac Vasc Anesth. 2019 Jan;33(1):209-222. doi: 10.1053/j.jvca.2018.04.048. Epub 2018 Apr 26. | |
| 27055812 | Background | Madonna R, Van Laake LW, Davidson SM, Engel FB, Hausenloy DJ, Lecour S, Leor J, Perrino C, Schulz R, Ytrehus K, Landmesser U, Mummery CL, Janssens S, Willerson J, Eschenhagen T, Ferdinandy P, Sluijter JP. Position Paper of the European Society of Cardiology Working Group Cellular Biology of the Heart: cell-based therapies for myocardial repair and regeneration in ischemic heart disease and heart failure. Eur Heart J. 2016 Jun 14;37(23):1789-98. doi: 10.1093/eurheartj/ehw113. Epub 2016 Apr 7. |
| Label | URL |
|---|---|
| Timing of intracoronary bone-marrow-derived stem cell transplantation after ST-elevation myocardial infarction. | View source |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation |
| 6 months |
| Major Cardiac Adverse Event (MACE) | Total death, recurrent myocardial infarction, revascularization with primary PCI or Coronary Artery Bypass Graft (CABG) surgery, stroke, rehospitalisation due to heart failure, haemorrhage and arrythmia malignant assess every months within 6 months after UC-MSC transplantation | 6 months |
| 26339251 | Background | Shen H, Wang Y, Zhang Z, Yang J, Hu S, Shen Z. Mesenchymal Stem Cells for Cardiac Regenerative Therapy: Optimization of Cell Differentiation Strategy. Stem Cells Int. 2015;2015:524756. doi: 10.1155/2015/524756. Epub 2015 Aug 3. |
| 19085935 | Background | Llano R, Epstein S, Zhou R, Zhang H, Hamamdzic D, Keane MG, Freyman T, Wilensky RL. Intracoronary delivery of mesenchymal stem cells at high flow rates after myocardial infarction improves distal coronary blood flow and decreases mortality in pigs. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):251-7. doi: 10.1002/ccd.21781. |
| 33304934 | Background | Charles CJ, Li RR, Yeung T, Mazlan SMI, Lai RC, de Kleijn DPV, Lim SK, Richards AM. Systemic Mesenchymal Stem Cell-Derived Exosomes Reduce Myocardial Infarct Size: Characterization With MRI in a Porcine Model. Front Cardiovasc Med. 2020 Nov 16;7:601990. doi: 10.3389/fcvm.2020.601990. eCollection 2020. |
| 19383393 | Background | Timmers L, Lim SK, Arslan F, Armstrong JS, Hoefer IE, Doevendans PA, Piek JJ, El Oakley RM, Choo A, Lee CN, Pasterkamp G, de Kleijn DP. Reduction of myocardial infarct size by human mesenchymal stem cell conditioned medium. Stem Cell Res. 2007 Nov;1(2):129-37. doi: 10.1016/j.scr.2008.02.002. Epub 2008 Mar 8. |
| 26162993 | Background | Gao LR, Chen Y, Zhang NK, Yang XL, Liu HL, Wang ZG, Yan XY, Wang Y, Zhu ZM, Li TC, Wang LH, Chen HY, Chen YD, Huang CL, Qu P, Yao C, Wang B, Chen GH, Wang ZM, Xu ZY, Bai J, Lu D, Shen YH, Guo F, Liu MY, Yang Y, Ding YC, Yang Y, Tian HT, Ding QA, Li LN, Yang XC, Hu X. Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial. BMC Med. 2015 Jul 10;13:162. doi: 10.1186/s12916-015-0399-z. |
| A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction. | View source |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |