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.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Timothy Huang, PhD
timothy.huang@twbio-thera.com
02-26956382
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 10
Treatments
Experimental: Low dose allogeneic mesenchymal stromal cells
Intracoronary administration 1.5 x 10\^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI
Experimental: High dose allogeneic mesenchymal stromal cells
Intracoronary administration 3.0 x 10\^7 OmniMSC-AMI in first AMI who just underwent primary PCI
Related Therapeutic Areas
Percutaneous Coronary Intervention (PCI)
Cardiogenic Shock
Heart Attack
Sponsors
Leads: Taiwan Bio Therapeutics Inc.

This content was sourced from clinicaltrials.gov

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