Status:
NOT_YET_RECRUITING
Safety and Efficacy of MiSaver (CB Cells) for Acute Myocardial Infarction, Phase II
Lead Sponsor:
HONYA Medical Co Ltd
Conditions:
Acute Myocardial Infarction (AMI)
Eligibility:
All Genders
45+ years
Phase:
PHASE2
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...
Detailed Description
We will enroll patients who have been diagnosed with acute myocardial infarction (AMI) within a timeframe of 36 hours to 7 days after the initial diagnosis. Eligible participants must be hemodynamical...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Subjects participating in more than one clinical trial.
- Inability to sign the consent form or comply with outpatient follow-up after infusion therapy.
- Patients with a known allergy to this product or its excipients (e.g., dimethyl sulfoxide, cell preservation solution).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07134712
Start Date
October 1 2025
End Date
December 31 2026
Last Update
August 21 2025
Active Locations (3)
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1
Mackay Memorial Hospital Hsinchu Branch
Hsinchu, Taiwan
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
3
Chung Shan Medical University Hospital Daqing Branch
Taichung, Taiwan