ST Elevation Myocardial InfarctionPhase 2NCT06147986
Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells as an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
A Phase 2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with ST Elevation Myocardial Infarction, run by Ever Supreme Bio Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2023to 24 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects are aged ≥ 20, < 76 years old on date of consent
- Presence of typical ischemic chest pain within 12 hours after symptoms onset and clinical diagnosis of acute STEMI according to the 2013 American College of Cardiology (ACC) Foundation/ American Heart Association (AHA) guideline for the Management of STEMI
- Has undergone standard-of-care for STEMI; the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms
- Received successful acute reperfusion therapy (residual stenosis visually < 50% and thrombolysis in myocardial infarction flow ≥ 2) with placement of an intracoronary stent and having a patent infarct-related artery suitable for cell infusion to the target area of abnormal wall motion following myocardial infarction
- Evidence of LVEF ≥ 30% and < 50% diagnosed by echocardiogram
- Evidence of stable vital signs prior to IC infusion of UMSC01 (Day 1), defined as no clinical significance of abnormal respiration, afebrile as judged by the investigator, systolic pressure ≥ 90 mmHg and < 160 mmHg, heart rate > 50/min and < 110/min
Show all 13Show fewer
- Adequate pulmonary function test defined as a force expiratory volume 1 second (FEV1) > 50% predicted and peripheral artery oxygen saturation ≥ 95% at room air
- Adequate hematopoietic function at the screening and before administration of study medication:
- Platelets ≥ 100,000 counts/μL.
- Hemoglobin ≥ 8 g/dL.
- PT, APTT ≤ 1.5X upper limit of normal (ULN).
- Has signed and dated informed consent
- All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) shown below, for at least 1 year after the last UMSC01 treatment a. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) b. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment c. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject d. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS) d.3 Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Who cannot join
- With cardiogenic shock (defined as systolic blood pressure <80mmHg requiring vasopressors, intra-aortic balloon pump(IABP) or extracorporeal membrane oxygenation (ECMO)
- Presence of severe aortic stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for themanagement of patients with valvular heart disease
- Presence of severe mitral stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for the management of patients with valvular heart disease
- With a need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery
- Under an immuno-compromised condition, with known clinically significantly autoimmune conditions, or receiving immunosuppressive treatments within 12 weeks prior to the study intervention
- Presence of any active malignancy that required treatment within 2 years prior to Screening Visit
Show all 13Show fewer
- With ongoing or within the past 2 years serious medical conditions (e.g., concurrent illness), other clinically significant cardiovascular diseases, psychiatric condition (e.g., alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- With inadequate hepatic and renal function after onset of STEMI: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 4 x upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) < 40 mL/min, calculated by Modification of Diet in Renal Disease equation (MDRD) 175 formula
- With uncontrolled diabetes mellitus (blood glucose level > 200 mg/dL or HbA1c ≥ 8.5%)
- Participation in a clinical trial of an investigational product within 3 months prior to Screening Visit
- Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product
- Female subject with child-bearing potential (between puberty and 2 years after menopause) who is pregnant, lactating or has positive urine pregnancy test at Screening Visit
- Subjects not suitable to participate the trial as judged by the Investigator(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Sammi Hsu, cthsu@ever-supreme.com.tw
Yu-Chen Wang, PhD
About this study
Official title: A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells as an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.
Read the detailed description
This is a two-stage Phase IIa, dose escalation followed by randomized, open-label, controlled with standard treatment, parallel-group study to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cell, UMSC01, as an add-on treatment in subjects with STEMI. Subjects should present typical ischemic chest pain within 12 hours after symptoms onset and are diagnosed acute STEMI. Subjects should have undergone standard-of-care for STEMI, the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy, and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms. This study aims to treat eligible subjects with UMSC01 as an add-on stem cell therapy along with standard-of-care for STEMI. The investigational product (IP), UMSC01, will be applied to subjects via intracoronary (IC) infusion on the 4th - 5th day after the onset of the heart attack, followed by intravenous (IV) infusion 2 days after the IC infusion.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells, Control group
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord mesenchymal stem cellsBiological
UMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.
Control groupOther
Standard-of-care for STEMI
| Study group | Role | What they receive |
|---|---|---|
| UMSC01 | Experimental | UMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of ST-elevation Myocardial Infarction. Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells |
| standard treatment | Other | Standard-of-care for ST-elevation Myocardial Infarction Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE) as presented by MedDRA coding system
AE incidences up to 1-month
Measured: from Day 1 to 1-month follow-up period
Incidence of Serious adverse event (SAE) as presented by MedDRA coding system
SAE incidences up to 1-month
Measured: from Day 1 to 1-month follow-up period
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
SUSAR incidences up to 1-month
Measured: from Day 1 to 1-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Change in peak oxygen consumption (VO2) at the end of maximal exercise over the study period
Measured: from Day 6 to 6-month follow-up period
Secondary outcomes (22)
Percentage of subject with cardiovascular hospitalizations or urgent care/ emergency room visits for heart failure/exacerbation of coronary artery disease (CAD)
The percentage of subject with cardiovascular hospitalizations or urgent care/ emergency room visits for heart failure/exacerbation of coronary artery disease (CAD) over the study period
Measured: from Day 3 to 24-month follow-up period
Percentage of subject with major adverse cardiovascular events (MACE)
The percentage of subject with major adverse cardiovascular events (MACE), including death, recurrent acute myocardial infarction (AMI), stroke, and target vessel revascularization over the study period
Measured: from Day 6 to 24-month follow-up period
Percentage of subject with ventricular tachycardia/ventricular fibrillation (VT/VF)
The percentage of subject with ventricular tachycardia/ventricular fibrillation (VT/VF) over the study period
Measured: from Day 6 to 24-month follow-up period
New York Heart Association (NYHA) Classification
Changes in New York Heart Association (NYHA) classification over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables regional left ventricular wall-motion score index (RWMSI) in total score over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular end-systolic volume (LVESV) in mL over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular end-diastolic volume (LVEDV) in mL over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables left ventricular ejection fraction (LVEF) in % over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables stroke volume (SV) in mL over the study period
Measured: from Day 6 to 24-month follow-up period
Echocardiography
Changes in echocardiography variables LV fractional shortening in % over the study period
Measured: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in peak oxygen consumption (VO2) at the end of maximal exercise over the study period
Measured: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in exercise time (min) at the end of maximal exercise over the study period
Measured: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in ventilatory efficiency/carbon dioxide production (VE/VCO2) slope at the end of maximal exercise over the study period
Measured: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Changes in peak heart rate at the end of maximal exercise over the study period
Measured: from Day 6 to 24-month follow-up period
6-minute walk distance (6MWD)
Changes in 6-minute walk distance (6MWD) over the study period
Measured: from Day 6 to 24-month follow-up period
Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Changes in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) over the study period
Measured: from Day 6 to 24-month follow-up period
cardiac enzyme levels
Changes in cardiac enzyme levels including creatinine kinase (CK), creatinine kinase-MB (CK-MB), and troponin I over the study period
Measured: from Day 6 to 1-month follow-up period
Pulmonary function test
Changes in forced expiratory volume (FEV1) will be tested by Spirometry over the study period
Measured: from Day 6 to 24-month follow-up period
Incidence of adverse event (AE) as presented by MedDRA coding system
AE incidences over the study period
Measured: from Day 3 to 24-month follow-up period
Incidence of serious adverse event (SAE) as presented by MedDRA coding system
SAE incidences over the study period
Measured: from Day 3 to 24-month follow-up period
Incidence of suspected and unexpected serious adverse reactions (SUSAR) s presented by MedDRA coding system
Suspected and unexpected serious adverse reactions (SUSAR) incidences over the study period
Measured: from Day 3 to 24-month follow-up period
12-lead ECG Test
Changes in 12-lead electrocardiogram (ECG) parameters in PR, QRS, QT, QTc, and RR intervals over the study period
Measured: from Day 1 to 24-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start24 Sep 2023
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woei C Shyu, Study director, Ever Supreme Bio Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147986
- Sponsor's protocol ID
- ES-CMSC01-A1201
- Status last verified
- Sep 2026
- First submitted
- 8 May 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells as an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
- ClinicalTrials.gov ID
- NCT06147986
- Acronym / sponsor ID
- ES-CMSC01-A1201
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Jun 2027 (estimated)
- First posted
- 28 Nov 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 phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.
Detailed description
This is a two-stage Phase IIa, dose escalation followed by randomized, open-label, controlled with standard treatment, parallel-group study to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cell, UMSC01, as an add-on treatment in subjects with STEMI. Subjects should present typical ischemic chest pain within 12 hours after symptoms onset and are diagnosed acute STEMI. Subjects should have undergone standard-of-care for STEMI, the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy, and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms. This study aims to treat eligible subjects with UMSC01 as an add-on stem cell therapy along with standard-of-care for STEMI. The investigational product (IP), UMSC01, will be applied to subjects via intracoronary (IC) infusion on the 4th - 5th day after the onset of the heart attack, followed by intravenous (IV) infusion 2 days after the IC infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UMSC01 | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of ST-elevation Myocardial Infarction. |
| standard treatment | Other | Other: Control groupStandard-of-care for ST-elevation Myocardial Infarction |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects are aged ≥ 20, < 76 years old on date of consent
- Presence of typical ischemic chest pain within 12 hours after symptoms onset and clinical diagnosis of acute STEMI according to the 2013 American College of Cardiology (ACC) Foundation/ American Heart Association (AHA) guideline for the Management of STEMI
- Has undergone standard-of-care for STEMI; the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms
- Received successful acute reperfusion therapy (residual stenosis visually < 50% and thrombolysis in myocardial infarction flow ≥ 2) with placement of an intracoronary stent and having a patent infarct-related artery suitable for cell infusion to the target area of abnormal wall motion following myocardial infarction
- Evidence of LVEF ≥ 30% and < 50% diagnosed by echocardiogram
Key exclusion criteria (13 listed)
- With cardiogenic shock (defined as systolic blood pressure <80mmHg requiring vasopressors, intra-aortic balloon pump(IABP) or extracorporeal membrane oxygenation (ECMO)
- Presence of severe aortic stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for themanagement of patients with valvular heart disease
- Presence of severe mitral stenosis or regurgitation according to the recommendation of the 2020 ACC/AHA guideline for the management of patients with valvular heart disease
- With a need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery
- Under an immuno-compromised condition, with known clinically significantly autoimmune conditions, or receiving immunosuppressive treatments within 12 weeks prior to the study intervention
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 |
|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment. | Biological | UMSC01 |
| Control groupStandard-of-care for STEMI | Other | standard treatment |
Primary outcome
Incidence of adverse event (AE) as presented by MedDRA coding system
Time frame: from Day 1 to 1-month follow-up period
AE incidences up to 1-month
Incidence of Serious adverse event (SAE) as presented by MedDRA coding system
Time frame: from Day 1 to 1-month follow-up period
SAE incidences up to 1-month
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
Time frame: from Day 1 to 1-month follow-up period
SUSAR incidences up to 1-month
Cardiopulmonary Exercise Testing (CPET)
Time frame: from Day 6 to 6-month follow-up period
Change in peak oxygen consumption (VO2) at the end of maximal exercise over the study period
22 secondary outcomes
Percentage of subject with cardiovascular hospitalizations or urgent care/ emergency room visits for heart failure/exacerbation of coronary artery disease (CAD)
Time frame: from Day 3 to 24-month follow-up period
Percentage of subject with major adverse cardiovascular events (MACE)
Time frame: from Day 6 to 24-month follow-up period
Percentage of subject with ventricular tachycardia/ventricular fibrillation (VT/VF)
Time frame: from Day 6 to 24-month follow-up period
New York Heart Association (NYHA) Classification
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Echocardiography
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Time frame: from Day 6 to 24-month follow-up period
Cardiopulmonary Exercise Testing (CPET)
Time frame: from Day 6 to 24-month follow-up period
6-minute walk distance (6MWD)
Time frame: from Day 6 to 24-month follow-up period
Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Time frame: from Day 6 to 24-month follow-up period
cardiac enzyme levels
Time frame: from Day 6 to 1-month follow-up period
Pulmonary function test
Time frame: from Day 6 to 24-month follow-up period
Incidence of adverse event (AE) as presented by MedDRA coding system
Time frame: from Day 3 to 24-month follow-up period
Incidence of serious adverse event (SAE) as presented by MedDRA coding system
Time frame: from Day 3 to 24-month follow-up period
Incidence of suspected and unexpected serious adverse reactions (SUSAR) s presented by MedDRA coding system
Time frame: from Day 3 to 24-month follow-up period
12-lead ECG Test
Time frame: from Day 1 to 24-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarctionLink provided by the sponsor.
Related trials for ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Woei C Shyu study director
Ever Supreme Bio Technology Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with ST Elevation Myocardial Infarction, run by Ever Supreme Bio Technology Co., Ltd. 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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sammi Hsu (886-4-2325-288, cthsu@ever-supreme.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE) as presented by MedDRA coding system (time frame: from Day 1 to 1-month follow-up period). The study lists 4 primary outcomes in all. 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 23 Sep 2026.