Not Yet RecruitingPhase 2ACTRN12626000412336

MiSaver Cell Injection for Heart Attack : Safety and Efficacy Study of Cells derived from Umbilical Cord Blood

A Phase 2, Multi-country, Multi-center, Prospective, Single-blind, Randomized, Placebo-controlled, safety, efficacy, and Dose Finding Study of MiSaver (Umbilical Cord Blood Nucleated Cells) in Subjects with Acute Myocardial Infarction.

Sponsor

HONYA Medical Co Ltd

Enrollment

102 participants

Start Date

Apr 28, 2026

Study Type

Interventional

Conditions

Acute Myocardial Infarction

Summary

This study evaluates the safety and effectiveness of MiSaver, a cell-based product, in patients who have had a heart attack. MiSaver is designed to help improve heart function. Early research suggests it may enhance heart pumping ability with an acceptable safety profile. The study hypothesizes that MiSaver is safe and improves heart function after a heart attack.

Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Inclusion Criteria7

Age and BMI:
Participants aged 45 years or older
Body Mass Index (BMI) less than or equal to 32
Diagnosis of Acute Myocardial Infarction (AMI): Includes both ST-Elevation Myocardial Infarction (STEMI) (whether or not primary PCI has been performed) and Non-ST-Elevation Myocardial Infarction (NSTEMI), diagnosed by a cardiologist within 36 hours post-AMI.
Timing for Cell Infusion: Patients must be able to initiate cell infusion within 36 hours to 7 days post-AMI diagnosis.
LVEF less than or equal to 45%: Left ventricular ejection fraction (LVEF) less than or equal to 45%, as assessed by 2D echocardiogram.
Hemodynamically Stable: Patients must be hemodynamically stable, requiring no vasopressor support in the past 24 hours.

Exclusion Criteria18

Women planning to conceive, currently pregnant, or breastfeeding.
Immunodeficiency disorders caused by infection, such as human immunodeficiency virus (HIV).
Requiring CABG or likely to need coronary revascularization within the next 12 months.
Severe aortic or mitral valve stenosis.
Life-threatening arrhythmias.
Active or recent malignancy. Note: Patients with active malignancy or malignancy
diagnosed within the past 5 years are excluded.
Hematologic disorders or other severe organ diseases with an expected survival of
less than one year.
Chronic kidney disease (eGFR less than 30 mL/min/1.73m²) or patients undergoing dialysis.
Subjects with autoimmune diseases or those who have already received
immunotherapy.
History of transfusion reactions.
Recipients of bone marrow or organ transplants.
Liver dysfunction, defined as a bilirubin level greater than 2.5 mg/dL or ALT and AST levels greater than five times the upper limit of normal (ULN).
Subjects who have previously received growth factors, cytokines, gene therapy, or stem cell therapy.
Current or previous participation in another study with investigational medicinal product within 90 days.
The Investigator is of the opinion the subject should not participate in the study.

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Interventions

This is a prospective, single-blind, randomized, placebo-controlled, parallel-group, multi-center, multi-region study evaluating the safety, efficacy, and dose response of MiSaver in subjects with acute myocardial infarction (AMI). A total of 102 subjects will be enrolled across approximately 9 to 14 study sites (3–6 sites in Taiwan and 6–8 sites in Australia). Eligible subjects will be randomly assigned in a 1:1:1 ratio to one of the following three treatment arms: 1. MiSaver low-dose group: 0.5 × 10^7 total nucleated cells (TNC)/kg 2. MiSaver high-dose group: 1.6 × 10^7 total nucleated cells (TNC)/kg 3. Placebo control group: normal saline MiSaver (a cell-based investigational product) or placebo (normal saline) will be administered as a single intracoronary infusion during the Treatment Phase, which occurs between 36 hours and 7 days following AMI diagnosis. The investigational product or placebo will be delivered once only (single administration) via standardized intracoronary infusion procedures across all study sites. The study consists of three phases: -Screening Phase: 0–36 hours post-AMI diagnosis -Treatment Phase: Single administration between 36 hours and 7 days post-AMI diagnosis -Follow-up Phase: 12 months after treatment Each participant will be followed for approximately 1 year to assess safety and efficacy outcomes. Efficacy Assessments and Procedures: 1. 2D Echocardiograms 2. Cardiac Magnetic Resonance Imaging 3. New York Heart Association Functional Classification 4. Canadian Cardiovascular Society Functional Classification of Angina Test 5. Kansas City Cardiomyopathy Questionnaire 6. Seattle Angina Questionnaire 7. Clinical Frailty Scale Safety Assessments and Procedures: 1. Physical Examination 2. Body Weight and Height 3. Vital Signs 4. Electrocardiograms 5. Clinical Laboratory Assessments