Safety IssuesPhase 1NCT05724576
Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
A Phase 1 study testing OmniMSC-AMI in people with Safety Issues, run by Taiwan Bio Therapeutics Inc. at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- OmniMSC-AMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jun 2023to 18 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 20 or >80 years old.
- History of
- Malignancy.
- Sepsis (abnormal WBC count elevation).
- Hematologic disorder.
- AIDS.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
Despite state-of-the-art advances in the treatment of acute myocardial infarction (AMI), including early and prompt reperfusion therapy and advanced pharmaceutical therapy, AMI remains the leading cause of death of patients hospitalized for cardiovascular disease. Loss of myocardium after AMI, resulting in reducing LVEF and ultimately pump failure, are essential for unfavorable clinical outcomes and mortality, highlighting that to protect the myocardium from AMI-induced damage is the principal rule for treatment of the AMI patients. The pathological findings have clearly identified that loss of myocardium after AMI results from first ischemic necrosis, followed by ischemia-reperfusion injury, vigorous inflammatory reaction, generation of oxidative stress, and finally, upregulation of immune reaction. Thus, a phenomenon of "propagation of myocardium from injury to irrepressible death" at the moment just after AMI always occurs. These are the reasons why a satisfactory therapy for AMI is still difficult, highlighting the timing remains the Achilles' heel for salving the jeopardized myocardium. These raise the consideration of urgently to develop a new effective and safe treatment for patients.
Abundant data have shown mesenchymal stromal cells (MSC) pleiotropic capacities of anti-inflammation, immunomodulation, and tissue regeneration. Experimental studies have further demonstrated that MSC therapy effectively protected the organs from ischemic/ischemia-reperfusion injury. However, the therapeutic impact of stem cells on the clinical setting of AMI is still universally controversial. When investigators further look at the clinical trials, delayed time to apply the stem cells on AMI patients is universally consistent. Investigators have demonstrated that early intracoronary administration (i.e., at the time interval of 90 minutes after AMI induction) of OmniMSC-AMI significantly protected the left ventricular myocardium and improved LVEF in the mini-pig AMI model. The aforementioned issues and the results of our experimental study may support our hypothesis that immediate intracoronary administration of OmniMSC-AMI into the infarcted-related vessel in first AMI patients who just yet underwent primary PCI will be safe and may offer benefits in improving LVEF and outcome.
- Conditions
- Safety Issues
- Being tested
- OmniMSC-AMI
- Keywords
- MSC, AMI, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniMSC-AMIBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Low dose allogeneic mesenchymal stromal cells | Experimental | Intracoronary administration 1.5 x 10^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI Receives: Biological: OmniMSC-AMI |
| High dose allogeneic mesenchymal stromal cells | Experimental | Intracoronary administration 3.0 x 10^7 OmniMSC-AMI in first AMI who just underwent primary PCI Receives: Biological: OmniMSC-AMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
Heart function after AMI
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Measured: 1-7 days
Heart function after treatment
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start26 Jun 2023
- Primary completion18 May 2026
- Study completion18 May 2026
Why it stopped: Sponsor's decision (No further development plan for this investigational product)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 10 anterior wall STEMI patients without cardiogenic shock will be enrolled into group 1 (i.e., will receive 1.5 x 107 OmniMSC-AMI, n=5) and then group 2 (3.0 x 107 OmniMSC-AMI, n=5).
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Bio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hon-Kan Yip, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724576
- Sponsor's protocol ID
- 202002401A0
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05724576
- Acronym / sponsor ID
- 202002401A0
- Conditions
- Safety Issues
- Keywords
- MSC, AMI, PCI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision (No further development plan for this investigational product)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Taiwan Bio Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite state-of-the-art advances in the treatment of acute myocardial infarction (AMI), including early and prompt reperfusion therapy and advanced pharmaceutical therapy, AMI remains the leading cause of death of patients hospitalized for cardiovascular disease. Loss of myocardium after AMI, resulting in reducing LVEF and ultimately pump failure, are essential for unfavorable clinical outcomes and mortality, highlighting that to protect the myocardium from AMI-induced damage is the principal rule for treatment of the AMI patients. The pathological findings have clearly identified that loss of myocardium after AMI results from first ischemic necrosis, followed by ischemia-reperfusion injury, vigorous inflammatory reaction, generation of oxidative stress, and finally, upregulation of immune reaction. Thus, a phenomenon of "propagation of myocardium from injury to irrepressible death" at the moment just after AMI always occurs. These are the reasons why a satisfactory therapy for AMI is still difficult, highlighting the timing remains the Achilles' heel for salving the jeopardized myocardium. These raise the consideration of urgently to develop a new effective and safe treatment for patients.
Abundant data have shown mesenchymal stromal cells (MSC) pleiotropic capacities of anti-inflammation, immunomodulation, and tissue regeneration. Experimental studies have further demonstrated that MSC therapy effectively protected the organs from ischemic/ischemia-reperfusion injury. However, the therapeutic impact of stem cells on the clinical setting of AMI is still universally controversial. When investigators further look at the clinical trials, delayed time to apply the stem cells on AMI patients is universally consistent. Investigators have demonstrated that early intracoronary administration (i.e., at the time interval of 90 minutes after AMI induction) of OmniMSC-AMI significantly protected the left ventricular myocardium and improved LVEF in the mini-pig AMI model. The aforementioned issues and the results of our experimental study may support our hypothesis that immediate intracoronary administration of OmniMSC-AMI into the infarcted-related vessel in first AMI patients who just yet underwent primary PCI will be safe and may offer benefits in improving LVEF and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 anterior wall STEMI patients without cardiogenic shock will be enrolled into group 1 (i.e., will receive 1.5 x 107 OmniMSC-AMI, n=5) and then group 2 (3.0 x 107 OmniMSC-AMI, n=5).
| Arm | Type | Receives |
|---|---|---|
| Low dose allogeneic mesenchymal stromal cells | Experimental | Biological: OmniMSC-AMIIntracoronary administration 1.5 x 10^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI |
| High dose allogeneic mesenchymal stromal cells | Experimental | Biological: OmniMSC-AMIIntracoronary administration 3.0 x 10^7 OmniMSC-AMI in first AMI who just underwent primary PCI |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patents, with age ≤20 or ≤80 years old.
- Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction):
- Into emergency ≤ 6h upon AMI presentation.
- Patients are willing to receive the treatment and sign the informed consent.
Key exclusion criteria (16 listed)
- Age < 20 or >80 years old.
- History of
- AMI occurrence > 6 hours
- Non-first AMI.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniMSC-AMI10 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). | Biological | High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 days
Number of adverse events occurring in given time frame shall be reported to evaluate overall safety.
2 secondary outcomes
Heart function after AMI
Time frame: 1-7 days
Heart function after treatment
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Sponsor's decision (No further development plan for this investigational product)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon-Kan Yip, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OmniMSC-AMI in people with Safety Issues, run by Taiwan Bio Therapeutics Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision (No further development plan for this investigational product)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.