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

ConditionSafety Issues
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-80
SponsorTaiwan Bio Therapeutics Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patents, with age ≤20 or ≤80 years old.

Chest pain onset.

12-lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.

TnT-I elevation.

Disqualifiers

Age < 20 or >80 years old.

History of

Malignancy.

Sepsis (abnormal WBC count elevation).

Trial design

Design model

Sequential

Treatments tested in this trial

  • OmniMSC-AMI

    Biological/Vaccine

    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).

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Low dose allogeneic mesenchymal stromal cellsExperimental treatment 1 intervention
Group B: High dose allogeneic mesenchymal stromal cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of adverse events occurring in given time frame shall be reported to evaluate overall safety.

Time frame
30 days

Secondary outcomes

1

Heart function after AMI

Cardiac MRI and 2-D/3-D echo LVEF results after administration

Time frame
1-7 days
2

Heart function after treatment

Cardiac MRI and 2-D/3-D echo LVEF results after administration

Time frame
6 months

Other outcomes

Sponsors and contacts

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