TerminatedPhase 1

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

Stopped: Sponsor's decision (No further development plan for this investigational product)

Taiwan1 participantsStarted 2023-06-26

Plain-language 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.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Chest pain onset.
. 12-lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.
. TnT-I elevation.

Exclusion criteria

. Malignancy.
. Sepsis (abnormal WBC count elevation).
. Hematologic disorder.
. AIDS.
. Advanced liver cirrhosis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated early — can you find out why it was stopped, and what that might mean for the safety or reliability of the data collected so far?
2Since this was a Phase 1 trial focused on counting treatment-related adverse events, what kinds of side effects were actually reported when OmniMSC cells were injected directly into the coronary arteries of heart attack patients?
3Given that this study has been terminated and wasn't designed to prove the treatment works — only to test safety — is there a standard-of-care treatment for STEMI that I should be considering instead of experimental cell therapy right now?
4Are there any other active or completed trials studying stem cell or MSC-based therapies for acute heart attacks that might be further along and have more safety and efficacy data available?
5Because the cells in this trial were delivered directly into the coronary arteries immediately after a heart attack, what specific risks does that delivery method carry, and how does my current heart condition affect whether that would even be appropriate for me to discuss with a specialist?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 30 days

Trial details

NCT IDNCT05724576

SponsorTaiwan Bio Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-18

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