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ST Elevation Myocardial InfarctionPhase 3NCT05935423

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

A Phase 3 study testing Umbilical Cord Mesenchymal Stem Cell transplantation in people with ST Elevation Myocardial Infarction, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Umbilical Cord Mesenchymal Stem Cell transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndonesia
Study dates
Jul 2023to Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with haemostasis disorder
  • Patients with infection
  • Patients with stroke

Trial locations and contacts

1 site in 1 country.

Dede Moeswir contact

+62 81287364648

dedemoeswir21@gmail.com

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, DKI Jakarta

Other trials in Indonesia

About this study

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

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

Read the detailed 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.

Being tested
Umbilical Cord Mesenchymal Stem Cell transplantation
Keywords
Umbilical Cord Mesenchymal Stem Cell, ST Elevation Myocardial Infarction, Infarct Size, Left Ventricular Ejection Fraction, IL-10, VEGF, Galectin 3, GATA-4, Beclin 1, Major Cardiac Adverse Events
Medical subject headings
ST Elevation Myocardial Infarction, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical Cord Mesenchymal Stem Cell transplantationBiological

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

Study groups in NCT05935423
Study groupRoleWhat they receive
UC-MSCExperimentalPatients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation
Receives: Biological: Umbilical Cord Mesenchymal Stem Cell transplantation
ControlNo interventionPatient 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (3)

  1. Left Ventricular Ejection Fraction (LVEF) with Echocardiography

    Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935423
Sponsor's protocol ID
23-02-0150
Status last verified
Jul 2023
First submitted
28 May 2023
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30029992

  • 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.

    PubMed 27055812

  • 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.

    PubMed 26339251

  • 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.

    PubMed 19085935

  • 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.

    PubMed 33304934

  • 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.

    PubMed 19383393

  • 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.

    PubMed 26162993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umbilical Cord Mesenchymal Stem Cell transplantation in people with ST Elevation Myocardial Infarction, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dede Moeswir (+62 81287364648, dedemoeswir21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarct size change (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935423, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

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