Actively Recruiting
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
Led by Taiwan Bio Therapeutics Inc. · Updated on 2025-06-06
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and potential benefits of intracoronary administration of OmniMSC-AMI, which are allogenic bone marrow-derived mesenchymal stem cells, in patients who have experienced acute ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock. Despite advances in treatment, loss of heart muscle after AMI remains a leading cause of death, and protecting this myocardium is key to improving outcomes. The study explores whether early administration of these stem cells after primary percutaneous coronary intervention (PCI) can improve heart function, specifically left ventricular ejection fraction (LVEF). The study involves two groups of patients receiving different doses of OmniMSC-AMI delivered directly into the coronary artery immediately after PCI. One group receives a low dose of 1.5 x 10^7 cells, and the other receives a high dose of 3.0 x 10^7 cells. This phase I clinical trial focuses on safety and monitoring adverse events following the treatment. Both groups include patients experiencing their first AMI and without cardiogenic shock. Participants will be closely monitored during the study for treatment-related side effects within 30 days. Heart function will be assessed shortly after AMI (1-7 days) and again at 6 months post-treatment to evaluate any changes in cardiac performance. The total participation duration spans up to 6 months, including clinical evaluations, laboratory tests, and imaging assessments to track heart function and safety outcomes. This study is sponsored by Taiwan Bio Therapeutics Inc.
CONDITIONS
Brief Title
Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 80 years old
- Diagnosed with first ST-elevation myocardial infarction (anterior myocardial infarction) confirmed by chest pain onset, 12-lead EKG showing ST-segment elevation ≥1 mm in V1-V6 leads, and elevated TnT-I
- Presentation within 6 hours of acute myocardial infarction
- Willing to receive treatment and able to sign informed consent
You will not qualify if you...
- Age under 20 or over 80 years old
- History of malignancy
- History of sepsis with abnormal elevated white blood cell count
- History of hematologic disorder
- Diagnosis of AIDS
- Advanced liver cirrhosis
- Chronic kidney disease stage 5 with creatinine clearance less than 15 ml/min
- Acute myocardial infarction occurrence more than 6 hours ago
- Not first myocardial infarction
- Pregnancy or breastfeeding
- Prisoner status
- Cancer treatment within the past 2 years
- Expected lifespan less than 6 months
- Considered unsuitable candidate by principal investigator
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration at the time of primary PCI
Participants receive intracoronary administration of OmniMSC-AMI immediately after primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.
1 treatment visit (in-person)
Duration - Up to 6 months
Participants are monitored for safety and heart function after treatment.
Visits at 1 to 7 days and at 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
Research Team
T
Timothy Huang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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