RecruitingPhase 1NCT05724576

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

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.

Sponsor

Taiwan Bio Therapeutics Inc.

Enrollment

10 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Safety Issues

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

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria7

Patents, with age ≤20 or ≤80 years old.
Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction):
Chest pain onset.
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 Criteria16

Age \< 20 or \>80 years old.
History of
Malignancy.
Sepsis (abnormal WBC count elevation).
Hematologic disorder.
AIDS.
Advanced liver cirrhosis.
CKD stage 5 with Ccr \<15 ml/min.
AMI occurrence \> 6 hours
Non-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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Interventions

BIOLOGICALOmniMSC-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).