Safety and Efficacy of MiSaver (CB Cells) for Acute Myocardial Infarction, Phase II

NCT07134712 | Not Yet Recruiting Phase 2 DMC

• 4 other identifiers: CshKmuhHcmmh2024CS1-2412724CT053AeKMUHIRB-F(I)-20250025
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 4

Brief Summary

This trial is a Phase II, multicenter clinical study. The purpose of this trial is to evaluate the safety and efficacy of MiSaver, a cellular therapy product, in patients who have experienced an acute myocardial infarction (AMI). Specifically, the study aims to assess the improvement in left ventricular function of the heart following the administration of MiSaver, as well as to determine the safety of using stem cell therapy in these patients. This trial will employ a single-blind design (subject-blinded), meaning that the participants will not be aware of whether they are receiving MiSaver or standard treatment, while the researchers will have this information. This design helps ensure transparency and adherence to ethical standards while also providing valuable clinical insights. By utilizing randomization, we can enhance the reliability and comparability of the study results. A portion of the participants will receive MiSaver, while the others will undergo standard treatment. This allows for a direct comparison of the two therapeutic approaches to determine their respective efficacy. The primary objective of this trial is to evaluate the safety and efficacy of MiSaver, in the treatment of patients with acute myocardial infarction (AMI). To achieve this, we will collect comprehensive participant data, including assessments of cardiac function, records of cardiac events, and quality-of-life surveys. By analyzing these data, we aim to gain a deeper understanding of the benefits and limitations of this treatment approach.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

heart attack; stem cell; Cardiovascular diseases

Outcome Measures

Primary Outcomes (3)

• AE

  Collection and assessment of all adverse events within 12 months after treatment, including type, incidence, and severity.

  From enrollment to the end of treatment at 12 months

• GVHD

  Proportion of patients developing Graft Versus Host Disease (GVHD) at the 3rd month after infusion.

  at the 3rd month after infusion.

• cardiovascular composite events

  Number and frequency of cardiovascular composite events, including myocardial infarction and stroke.

  From enrollment to the end of treatment at 12 months.

Secondary Outcomes (3)

• LVEF

  Cardiac function was evaluated with 2D Doppler echo before treatement and at the third, sixth, ninth and 12th month.

• Cardiovascular-related mortality

  12 months after treatment

• Incidence of new myocardial infarction (NMI)

  12 months after treatment

Study Arms (3)

LDRSB

EXPERIMENTAL

One-time infusion 0.5 x10\^7 TNCs/kg

Biological: Cord Blood Nucleated cells

MDRSB

EXPERIMENTAL

One-time infusion 1.6 x10\^7 TNCs/kg

Biological: Cord Blood Nucleated cells

PCRSB

PLACEBO COMPARATOR

One-time infusion saline 30ml

Biological: Cord Blood Nucleated cells

Interventions

Cord Blood Nucleated cells BIOLOGICAL

MiSaver will be administered via peripheral intravenous injection. Based on dosage, the experimental group will be divided into two subgroups: 0.5 × 10⁷ or 1.6 × 10⁷ nucleated cells per kilogram of patient body weight.

LDRSB; MDRSB; PCRSB

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years, BMI ≤ 32
• Patients diagnosed with acute myocardial infarction by a cardiologist, within 36 hours to 7 days post-diagnosis, and able to complete cell infusion within this period.
• Left ventricular ejection fraction (LVEF) ≤ 45%, hemodynamically stable patients who do not require vasopressor support within 24 hours.
• Patients with a history of coronary artery disease, who have previously undergone percutaneous coronary intervention or coronary artery bypass graft surgery, may also be included upon evaluation by a cardiologist.
• Patients deemed unsuitable for percutaneous coronary intervention or coronary artery bypass graft surgery by a cardiologist.
• Must agree to sign the informed consent form.
• Subjects must use effective contraception during the study observation period and for 6 months after its conclusion to ensure no pregnancy occurs during the study. (Primarily for women of childbearing potential).
• Agree to and comply with the required outpatient visits and examinations during the study observation period.

You may not qualify if:

• Age \< 45 years, BMI \> 32.
• Women who are planning to become pregnant, are pregnant, or are breastfeeding
• Immunodeficiency diseases caused by infection , such as Human Immunodeficiency Virus (HIV).
• Patients diagnosed as needing coronary artery bypass surgery or potentially requiring coronary revascularization surgery within the next 6 months.
• Severe aortic or mitral valve stenosis.
• Life-threatening arrhythmias.
• Malignant tumors, including all categories and cancer conditions.
• Hematologic disorders or other severe organ diseases with an expected survival of less than one year.
• Chronic kidney disease (eGFR \< 30 mL/min/1.73m²) or patients undergoing dialysis.
• Patients with autoimmune diseases or those who have already received immunotherapy.
• Patients who have undergone tumor treatment or require immunosuppressive therapy within the last three years.
• History of transfusion reactions.
• Recipients of bone marrow or organ transplants.
• Liver dysfunction (bilirubin \> 2.5 mg/dL or transaminases \> 5x the upper limit of normal).
• Patients who have previously received growth factors, cytokines, gene therapy, or stem cell therapy.

Sponsors & Collaborators

• HONYA Medical Co Ltd: lead

Study Sites (4)

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Mackay Memorial Hospital Hsinchu Branch

Hsinchu, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hospital Daqing Branch

Taichung, Taiwan

Location

MeSH Terms

Conditions

Myocardial Infarction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kwo-Chang Ueng, PhD

  Chung Shan Medical University

  STUDY DIRECTOR

Central Study Contacts

Shuzhen Lee, Mb Bch

CONTACT

+886424739595; uengstudy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

AU (1); TW (3)