Acute Myocardial Infarction (AMI)Phase 2SEMIAMINCT07134712
Safety and Efficacy of MiSaver (CB Cells) for Acute Myocardial Infarction, Phase II
A Phase 2 study testing Cord Blood Nucleated cells in people with Acute Myocardial Infarction (AMI), run by HONYA Medical Co Ltd at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Cord Blood Nucleated cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Taiwan3 sites
Mackay Memorial Hospital Hsinchu Branch
Hsinchu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chung Shan Medical University Hospital Daqing Branch
Taichung
Australia1 site
Flinders Medical Centre
Bedford Park, South Australia, 5042
JOSEPH BRINDABAN Professor of Cardiovascular Medicine, MBBS, +61450252616, honyamedical@gmail.com
About this study
Official title: Safety and Efficacy Study of Intravenous Administration of MiSaver (Umbilical Cord Blood Derived Nucleated Cells) After Acute Myocardial Infarction
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.
Read more
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.
Read the detailed description
The investigators 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 hemodynamically stable at the time of enrollment. Hemodynamic stability is defined as not requiring vasopressor support within the past 24 hours, having a systolic blood pressure (SBP) of less than 80 mmHg for no more than one hour, and not experiencing a resting heart rate of over 100 beats per minute for more than one hour.
Additionally, eligible patients must have undergone successful reperfusion therapy or coronary angiography confirming the absence of infarction at the time of screening. Only patients who are willing to receive MiSaver cellular therapy will be included in the study.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Cord Blood Nucleated cells
- Keywords
- heart attack, stem cell, Cardiovascular diseases
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Blood Nucleated cellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| LDRSB | Experimental | One-time infusion 0.5 x10^7 TNCs/kg Receives: Biological: Cord Blood Nucleated cells |
| MDRSB | Experimental | One-time infusion 1.6 x10^7 TNCs/kg Receives: Biological: Cord Blood Nucleated cells |
| PCRSB | Placebo comparator | One-time infusion saline 30ml Receives: Biological: Cord Blood Nucleated cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Collection and assessment of all adverse events within 12 months after treatment, including type, incidence, and severity.
Measured: 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.
Measured: at the 3rd month after infusion.
cardiovascular composite events
Number and frequency of cardiovascular composite events, including myocardial infarction and stroke.
Measured: From enrollment to the end of treatment at 12 months.
Secondary outcomes (3)
LVEF
Evaluation of treatment efficacy through 2D echocardiography to assess left ventricular volume and ejection fraction.
Measured: Cardiac function was evaluated with 2D Doppler echo before treatement and at the third, sixth, ninth and 12th month.
Cardiovascular-related mortality
Cardiovascular-related mortality record within 12 months after treatment
Measured: 12 months after treatment
Incidence of new myocardial infarction (NMI)
Incidence of new myocardial infarction (NMI), with a clear definition provided, such as symptoms, elevated cardiac enzymes, and ECG changes.
- Non-fatal stroke.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start30 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HONYA Medical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwo-Chang Ueng, PhD, Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134712
- Sponsor's protocol ID
- CshKmuhHcmmh2024
- Other IDs
- CS1-24127, 24CT053Ae, KMUHIRB-F(I)-20250025
- Acronym
- SEMIAMI
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Intravenous Administration of MiSaver (Umbilical Cord Blood Derived Nucleated Cells) After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07134712
- Acronym / sponsor ID
- SEMIAMI / CshKmuhHcmmh2024
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- heart attack, stem cell, Cardiovascular diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- HONYA Medical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators 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 hemodynamically stable at the time of enrollment. Hemodynamic stability is defined as not requiring vasopressor support within the past 24 hours, having a systolic blood pressure (SBP) of less than 80 mmHg for no more than one hour, and not experiencing a resting heart rate of over 100 beats per minute for more than one hour.
Additionally, eligible patients must have undergone successful reperfusion therapy or coronary angiography confirming the absence of infarction at the time of screening. Only patients who are willing to receive MiSaver cellular therapy will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LDRSB | Experimental | Biological: Cord Blood Nucleated cellsOne-time infusion 0.5 x10^7 TNCs/kg |
| MDRSB | Experimental | Biological: Cord Blood Nucleated cellsOne-time infusion 1.6 x10^7 TNCs/kg |
| PCRSB | Placebo comparator | Biological: Cord Blood Nucleated cellsOne-time infusion saline 30ml |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord Blood Nucleated cellsMiSaver 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. | Biological | LDRSB, MDRSB, PCRSB |
Primary outcome
AE
Time frame: From enrollment to the end of treatment at 12 months
Collection and assessment of all adverse events within 12 months after treatment, including type, incidence, and severity.
GVHD
Time frame: at the 3rd month after infusion.
Proportion of patients developing Graft Versus Host Disease (GVHD) at the 3rd month after infusion.
cardiovascular composite events
Time frame: From enrollment to the end of treatment at 12 months.
Number and frequency of cardiovascular composite events, including myocardial infarction and stroke.
3 secondary outcomes
LVEF
Time frame: Cardiac function was evaluated with 2D Doppler echo before treatement and at the third, sixth, ninth and 12th month.
Cardiovascular-related mortality
Time frame: 12 months after treatment
Incidence of new myocardial infarction (NMI)
Time frame: 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kwo-Chang Ueng, PhD study director
Chung Shan Medical University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cord Blood Nucleated cells in people with Acute Myocardial Infarction (AMI), run by HONYA Medical Co Ltd at 4 sites in 2 countries.
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 8 inclusion and 18 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: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan, Australia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuzhen Lee, Mb Bch (+886424739595, uengstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: From enrollment to the end of treatment at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.