ClinicalTrials.gg
RecruitingNCT06147986Updated Sep 23, 2026

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 interventional study of Allogeneic umbilical cord mesenchymal stem cells and Control group in ST Elevation Myocardial Infarction, sponsored by Ever Supreme Bio Technology Co., Ltd.. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Ever Supreme Bio Technology Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in ST Elevation Myocardial Infarction with a site in Taiwan — 2 open to participants now, 2 under way, none of them phase 3. ST Elevation Myocardial Infarction · Taiwan.

Started
2023
the only one that year
Phase 2
Only one
of the 10
Registered
9th of 10
by date
Lead sponsor
1 of 10
Ever Supreme Bio Technology Co., Ltd.

Among the 10 studies in ST Elevation Myocardial Infarction with a site in Taiwan, this one is the only one that started in 2023, is the only one in phase 2, and was the 9th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Observational4 · 0 open
Phase 32 · 0 open
Phase 42 · 1 open
No phase1 · 0 open
Phase 2this study1 · 1 open

By the year they started

First in 1997; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 1,444 across the 6 interventional studies, 565 across the 4 observational. Of the 7 that completed or were terminated, 4 (57%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in ST Elevation Myocardial Infarction with a site in Taiwan, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • ST Elevation Myocardial Infarction
04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects are aged ≥ 20, \< 76 years old on date of consent
  2. 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
  3. 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
  4. 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
  5. Evidence of ≥ 30% and \< 50% diagnosed by echocardiogram
  6. 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
  7. Adequate pulmonary function test defined as a force expiratory volume 1 second () > 50% predicted and peripheral artery oxygen saturation ≥ 95% at room air
  8. Adequate hematopoietic function at the screening and before administration of study medication:

    • ≥ 100,000 counts/μL.
    • ≥ 8 g/dL.
    • PT, ≤ 1.5X (ULN).
  9. Has signed and dated
  10. All male subjects and female subjects with (between puberty and 2 years after menopause) should use appropriate 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

Exclusion criteria

Exclusion Criteria:

  1. With cardiogenic shock (defined as systolic blood pressure \<80mmHg requiring vasopressors, intra-aortic balloon pump(IABP) or extracorporeal membrane oxygenation (ECMO)
  2. 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
  3. 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
  4. With a need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery
  5. Under an immuno-compromised condition, with known clinically significantly conditions, or receiving treatments within 12 weeks prior to the study intervention
  6. Presence of any active that required treatment within 2 years prior to Screening Visit
  7. With ongoing or within the past 2 years serious medical conditions (e.g., concurrent illness), other 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
  8. With inadequate hepatic and renal function after onset of STEMI: (AST) and alanine aminotransferase (ALT) ≥ 4 x (ULN); estimated (eGFR) \< 40 mL/min, calculated by Modification of Diet in Renal Disease equation (MDRD) 175 formula
  9. With uncontrolled diabetes mellitus (blood glucose level > 200 mg/dL or ≥ 8.5%)
  10. Participation in a clinical trial of an product within 3 months prior to Screening Visit
  11. Known or suspected or previous adverse reaction to any ingredients of study product
  12. Female subject with (between puberty and 2 years after menopause) who is pregnant, lactating or has positive urine pregnancy test at Screening Visit
  13. Subjects not suitable to participate the trial as judged by the Investigator(s)
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (estimated)

Study arms

  • Experimental
    UMSC01

    UMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of ST-elevation Myocardial Infarction.

    Biological: Allogeneic umbilical cord mesenchymal stem cells

  • Other
    standard treatment

    Standard-of-care for ST-elevation Myocardial Infarction

    Other: Control group

Interventions

  • BiologicalAllogeneic umbilical cord mesenchymal stem cells

    UMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.

  • OtherControl group

    Standard-of-care for STEMI

06

What researchers measure

Primary outcomes

  1. Incidence of adverse event (AE) as presented by MedDRA coding system

    AE incidences up to 1-month

    Time frame: from Day 1 to 1-month follow-up period

  2. Incidence of Serious adverse event (SAE) as presented by MedDRA coding system

    SAE incidences up to 1-month

    Time frame: from Day 1 to 1-month follow-up period

  3. Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system

    SUSAR incidences up to 1-month

    Time frame: from Day 1 to 1-month follow-up period

  4. Cardiopulmonary Exercise Testing (CPET)

    Change in peak oxygen consumption (VO2) at the end of maximal exercise over the study period

    Time frame: from Day 6 to 6-month follow-up period

Secondary outcomes

  1. 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

    Time frame: from Day 3 to 24-month follow-up period

  2. 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

    Time frame: from Day 6 to 24-month follow-up period

  3. 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

    Time frame: from Day 6 to 24-month follow-up period

  4. New York Heart Association (NYHA) Classification

    Changes in New York Heart Association (NYHA) classification over the study period

    Time frame: from Day 6 to 24-month follow-up period

  5. Echocardiography

    Changes in echocardiography variables regional left ventricular wall-motion score index (RWMSI) in total score over the study period

    Time frame: from Day 6 to 24-month follow-up period

  6. Echocardiography

    Changes in echocardiography variables left ventricular end-systolic volume (LVESV) in mL over the study period

    Time frame: from Day 6 to 24-month follow-up period

  7. Echocardiography

    Changes in echocardiography variables left ventricular end-diastolic volume (LVEDV) in mL over the study period

    Time frame: from Day 6 to 24-month follow-up period

  8. Echocardiography

    Changes in echocardiography variables left ventricular ejection fraction (LVEF) in % over the study period

    Time frame: from Day 6 to 24-month follow-up period

  9. Echocardiography

    Changes in echocardiography variables stroke volume (SV) in mL over the study period

    Time frame: from Day 6 to 24-month follow-up period

  10. Echocardiography

    Changes in echocardiography variables LV fractional shortening in % over the study period

    Time frame: from Day 6 to 24-month follow-up period

  11. Cardiopulmonary Exercise Testing (CPET)

    Changes in peak oxygen consumption (VO2) at the end of maximal exercise over the study period

    Time frame: from Day 6 to 24-month follow-up period

  12. Cardiopulmonary Exercise Testing (CPET)

    Changes in exercise time (min) at the end of maximal exercise over the study period

    Time frame: from Day 6 to 24-month follow-up period

  13. Cardiopulmonary Exercise Testing (CPET)

    Changes in ventilatory efficiency/carbon dioxide production (VE/VCO2) slope at the end of maximal exercise over the study period

    Time frame: from Day 6 to 24-month follow-up period

  14. Cardiopulmonary Exercise Testing (CPET)

    Changes in peak heart rate at the end of maximal exercise over the study period

    Time frame: from Day 6 to 24-month follow-up period

  15. 6-minute walk distance (6MWD)

    Changes in 6-minute walk distance (6MWD) over the study period

    Time frame: from Day 6 to 24-month follow-up period

  16. 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

    Time frame: from Day 6 to 24-month follow-up period

  17. cardiac enzyme levels

    Changes in cardiac enzyme levels including creatinine kinase (CK), creatinine kinase-MB (CK-MB), and troponin I over the study period

    Time frame: from Day 6 to 1-month follow-up period

  18. Pulmonary function test

    Changes in forced expiratory volume (FEV1) will be tested by Spirometry over the study period

    Time frame: from Day 6 to 24-month follow-up period

  19. Incidence of adverse event (AE) as presented by MedDRA coding system

    AE incidences over the study period

    Time frame: from Day 3 to 24-month follow-up period

  20. Incidence of serious adverse event (SAE) as presented by MedDRA coding system

    SAE incidences over the study period

    Time frame: from Day 3 to 24-month follow-up period

  21. 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

    Time frame: from Day 3 to 24-month follow-up period

  22. 12-lead ECG Test

    Changes in 12-lead electrocardiogram (ECG) parameters in PR, QRS, QT, QTc, and RR intervals over the study period

    Time frame: from Day 1 to 24-month follow-up period

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jun 2027, 45 months after the start.

Of 31 phase 2 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 45 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2023
First posted
Nov 28, 2023
StartActual
Sep 24, 2023
Primary completionEst.
Jun 24, 2027
CompletionEst.
Jun 24, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06147986
Lead sponsor
Ever Supreme Bio Technology Co., Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2023
Start date
Sep 24, 2023
Primary completion
Jun 24, 2027 (estimated)
Completion
Jun 24, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Sammi Hsu
Contact
cthsu@ever-supreme.com.tw
886-4-2325-288
Jack Tsai
Contact
cktsai@ever-supreme.com.tw
886-4-2325-288 ext. 517
Woei C Shyu
study director · Ever Supreme Bio Technology Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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