NCT05935423

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

May 28, 2023

Last Update Submit

July 5, 2023

Conditions

ST Elevation Myocardial Infarction

Keywords

Umbilical Cord Mesenchymal Stem CellST Elevation Myocardial InfarctionInfarct SizeLeft Ventricular Ejection FractionIL-10VEGFGalectin 3GATA-4Beclin 1Major Cardiac Adverse Events

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Left Ventricular Ejection Fraction (LVEF) with Echocardiography

    6 months

  • Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI

    6 months

  • Major Cardiac Adverse Event (MACE)

    6 months

Study Arms (2)

UC-MSC

EXPERIMENTAL

Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation

Biological: 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

Interventions

Umbilical Cord Mesenchymal Stem Cell transplantationBIOLOGICAL

50 million UC MSC will be transplanted 10-15 days after primary PCI

UC-MSC

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Related Publications (7)

  • 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.

    PMID: 30029992BACKGROUND

  • 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.

    PMID: 27055812BACKGROUND

  • 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.

    PMID: 26339251BACKGROUND

  • 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.

    PMID: 19085935BACKGROUND

  • 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.

    PMID: 33304934BACKGROUND

  • 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.

    PMID: 19383393BACKGROUND

  • 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.

    PMID: 26162993BACKGROUND

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Dede Moeswir

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dede Moeswir

CONTACT

+62 81287364648dedemoeswir21@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2023

First Posted

July 7, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations

ID(1)