Umbilical Cord Mesenchymal Stem Cell Improve Cardiac Function on ST-elevation Myocardial Infarction (STEMI) Patients

ST Elevation Myocardial Infarction Clinical Trial

Official title:

Intracoronary Allogenic Umbilical Cord Mesenchymal Stem Cell Reduce Infarct Size, Reverse Remodelling, and Improve Cardiac Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935423
• Other study ID #: 23-02-0150
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2023
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Indonesia University
• Contact: Dede Moeswir
• Phone: +62 81287364648
• Email: dedemoeswir21[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with STEMI treated with primary PCI maximum 12 hours after onset of chest pain

Exclusion Criteria:

• Patients with history of coronary artery bypass grafting surgery
• Patients with history of heart failure before admission
• Patients with cardiogenic shock
• Patients with cancer disease
• Patients with malignant arrythmia
• Patients with chronic kidney disease
• Patients with haemostasis disorder
• Patients with infection
• Patients with stroke

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Biological:
• Umbilical Cord Mesenchymal Stem Cell transplantation
50 million UC MSC will be transplanted 10-15 days after primary PCI

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI	Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation	6 months
Secondary	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

External Links

•   A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.
•   Timing of intracoronary bone-marrow-derived stem cell transplantation after ST-elevation myocardial infarction.