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Not Yet Recruiting NCT05724576

Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients

Conditions: Safety Issues

Sex: All
Ages: 20 Years – 80 Years
Phase: PHASE1
Enrollment: 10
Sponsor: Taiwan Bio Therapeutics Co., Ltd.

Location: Taiwan

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.

Eligibility Criteria

Inclusion Criteria:Patents, with age ≤20 or ≤80 years old.Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction):Chest pain onset.12-lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.TnT-I elevation.Into emergency ≤ 6h upon AMI presentation.Patients are willing to receive the treatment and sign the informed consent.Exclusion Criteria:Age < 20 or >80 years old.History ofMalignancy.Sepsis (abnormal WBC count elevation).Hematologic disorder.AIDS.Advanced liver cirrhosis.CKD stage 5 with Ccr <15 ml/min.AMI occurrence > 6 hoursNon-first AMI.Pregnancy or breastfeeding.Prison.Cancer treatment within 2 years.Expected lifespan < 6 months.Non-suitable candidate evaluated by PI.Participating in other clinical trials.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05724576). StuddyBuddy aggregates publicly available trial information.