Acute Myocardial Infarction Clinical Trial
Official title:
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
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. Primary Endpoint: The 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. Secondary Outcomes: Secondary 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.
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. (Study details for low and middle dose please see study NCT04050163) Retrospective 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04451967 -
Acute Myocardial Infarction Study in Northeastern China
|
||
| Completed |
NCT05974397 -
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
|
||
| Not yet recruiting |
NCT04072081 -
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
|
N/A | |
| Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
| Recruiting |
NCT03707626 -
Collateral Circulation to LAD and Wellens Sign
|
||
| Completed |
NCT02669810 -
EXCELLENT (EXpanded CELL ENdocardiac Transplantation)
|
Phase 2 | |
| Not yet recruiting |
NCT04104048 -
Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
|
||
| Active, not recruiting |
NCT02915107 -
The SORT OUT IX STEMI OCT Trial
|
N/A | |
| Completed |
NCT02896543 -
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction
|
N/A | |
| Withdrawn |
NCT01901471 -
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
|
Phase 2 | |
| Completed |
NCT02531165 -
Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
|
N/A | |
| Completed |
NCT02490969 -
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
|
N/A | |
| Completed |
NCT02312336 -
A Pilot Study of Transcoronary Myocardial Cooling
|
N/A | |
| Recruiting |
NCT02071342 -
Study of ABSORB Stent in Acute Myocardial Infarction
|
N/A | |
| Terminated |
NCT01972126 -
MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction
|
N/A | |
| Completed |
NCT02070913 -
COOL-AMI EU Case Series Clinical Study
|
||
| Completed |
NCT01216995 -
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
|
Phase 2 | |
| Completed |
NCT01887080 -
Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program
|
N/A | |
| Withdrawn |
NCT01678339 -
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
|
N/A | |
| Completed |
NCT01325116 -
Delayed Educational Reminders in Acute Myocardial Infarction (MI)
|
N/A |