Stem Cell in Acute Myocardial Infarction

Phase 1

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT04340609
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Primary Completion: 2021-04-08
• Study Completion: 2022-04-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart failure hospitalization	12 months after stem cell	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality	12 months after stem cell	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction	12 months after stem cell	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)	12 months after stem cell	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

Secondary Outcome Measures

Name	Time	Method
Electrocardiography (ECG)	12 months after stem cell	to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Echocardiography	12 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.
Cardiac MRI	12 months after stem cell	a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Wellness Parameter	6 months after stem cell	hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen
Laboratory Assessment	12 months after stem cell	Haematology, Serum Chemistry, Cardiac Biomarker

Trial Locations

Locations (1)

PT Prodia StemCell Indonesia; 🇮🇩 Jakarta, Indonesia