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Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
Sponsor: Taiwan Bio Therapeutics Inc.
Summary
This study will test the hypothesis intracoronary administration of OmniMSC-AMI (allogenic bone marrow-derived mesenchymal stem cells) just after finishing the primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) patients without cardiogenic shock is safe and may provide benefit on improving left ventricular ejection fraction (LVEF) during clinical follow-up.
Official title: Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention-Phase I Clinical Trial to Assess the Safety.
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-06-26
Completion Date
2026-03-01
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
OmniMSC-AMI
10 anterior wall STEMI patients without cardiogenic shock will be enrolled into low dose group 1 (1.5 x 10\^7 OmniMSC-AMI, n=5) and then high dose group 2 (3.0 x 10\^7 OmniMSC-AMI, n=5).
Locations (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan