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| ID | Type | Description | Link |
|---|---|---|---|
| CS1-24127 | Other Identifier | The Institutional Review Board Chung Shan Medical University Hospital | |
| 24CT053Ae | Other Identifier | MacKay Memorial Hospital Institutional Review Board Approval of Clinical Trial | |
| KMUHIRB-F(I)-20250025 | Other Identifier | Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDRSB | Experimental | One-time infusion 0.5 x10^7 TNCs/kg |
|
| MDRSB | Experimental | One-time infusion 1.6 x10^7 TNCs/kg |
|
| PCRSB | Placebo Comparator | One-time infusion saline 30ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LVEF | Evaluation of treatment efficacy through 2D echocardiography to assess left ventricular volume and ejection fraction. | Cardiac function was evaluated with 2D Doppler echo before treatement and at the third, sixth, ninth and 12th month. |
| Cardiovascular-related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuzhen Lee, Mb Bch | Contact | +886424739595 | uengstudy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kwo-Chang Ueng, PhD | Chung Shan Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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Cardiovascular-related mortality record within 12 months after treatment |
| 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. d. Non-fatal stroke. | 12 months after treatment |
| Mackay Memorial Hospital Hsinchu Branch | Hsinchu | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Chung Shan Medical University Hospital Daqing Branch | Taichung | Taiwan |
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |