Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06353958
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2024-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MiSaver® Stem Cell Treatment for Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and adverse events events', 'timeFrame': '12 months', 'description': 'The primary endpoint focused on safety evaluation and is measure with number of adverse events (AEs) over a 12-month observational period.'}], 'secondaryOutcomes': [{'measure': 'Efficacy on ventricular ejection fraction (LVEF) improvement', 'timeFrame': '12 months', 'description': 'Changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.\n\nPrimary Endpoint:\n\nThe primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.\n\nSecondary Outcomes:\n\nSecondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.', 'detailedDescription': 'Cardiovascular diseases, particularly acute myocardial infarction (AMI), persist as significant health concerns despite advancements in pharmaceutical and interventional treatments. Herein,investigators hypothesized stem cells could enhance left ventricular functional outcomes in patients recently afflicted by acute myocardial infarction (AMI). To investigate this hypothesis, investigators initiated an open-label, dose-escalating trial to evaluate the safety and feasibility of intravenous infusion of ABO matched allogeneic umbilical cord blood stem cells (USC), prefabricated into our study product MiSaver (Myocardial Infarction Functional Saver), in patients following recent AMI. Participants were enrolled in cohorts of five, each receiving low or middle dosages (0.5x10\\^7 and 1.6x10\\^7 cells/kg, respectively), with infusions administered 2-5 days post-AMI onset.\n\n(Study details for low and middle dose please see study NCT04050163)\n\nRetrospective participants meeting similar inclusion criteria of recent AMI and LVEF \\< 45% were identified from the study site. Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Control group were retrospectively data retried from the study site, comprising 20 eligible participants meeting similar inclusion criteria for recent AMI and left ventricular ejection fraction (LVEF) \\< 45% was compared for analysis with the low and middle dosage groups.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 20 and 80 years\n* Diagnosed with AMI within 7 days\n* Elevated cardiac enzymes (Creatine Kinase-MB or troponin) greater than 2 times the upper limit of normal\n* Presence of regional wall motion abnormality\n* LVEF ≤ 45% on echocardiography\n* Hemodynamically stable\n* Not requiring inotropic support\n* Systolic blood pressure below 80mm Hg for less than 1 hour\n* Resting heart rate above 100 beats/min for less than 1 hour in the past 24 hours\n* Peripheral artery oxygen saturation of ≥97%\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Positive adventitious infections (such as HIV, hepatitis)\n* Need for coronary artery bypass surgery or anticipated further revascularization procedures during the 6-month study period\n* Severe aortic or mitral valve narrowing\n* Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)\n* Inability to receive PCI examination or treatment (including New York Heart Association (NYHA) Fc.IV) due to shortness of breath\n* Malignant tumor\n* Hematopoietic dysplasia\n* Other severe organ disease\n* Less than 1 year of life expectancy\n* Chronic kidney disease with estimated Glomerular Filtration Rate (eGFR)\\<20 and/or on renal dialysis'}, 'identificationModule': {'nctId': 'NCT06353958', 'acronym': 'MiSaver®', 'briefTitle': 'MiSaver® Stem Cell Treatment for Acute Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Honya Medical Inc'}, 'officialTitle': 'A Retrospective Phase IIa Study of Intravenous Allogeneic Non-HLA-Matched, Unrelated Donor Stem Cell, MiSaver (Myocardial Infarction Saver), Infusion for Recent Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'MiSaver PIIa'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low', 'description': 'Low dosage of MiSaver cells at 0.5x10\\^7 cells/kg', 'interventionNames': ['Drug: MiSaver']}, {'label': 'Middle', 'description': 'Middle dosage of MiSaver cells at 1.6x10\\^7 cells/kg', 'interventionNames': ['Drug: MiSaver']}], 'interventions': [{'name': 'MiSaver', 'type': 'DRUG', 'description': 'MiSaver vials was thawed using a thermostat-controlled mini bath, drawn into a 20ml syringe, and diluted with normal saline and intravenous infused following standard operating procedures, consecutively, until reasching the dosage.\n\nPatients were premedicated with intravenous antihistamines (such as diphenhydramine) and corticosteroids (such as hydrocortisone) 30-60 minutes before the stem cell infusion. Any unused solution was discarded, and the total volume of injected solution was adjusted to accommodate the total daily fluid volume administered.', 'armGroupLabels': ['Low', 'Middle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Honya Medical Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chung Shan Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}