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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 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

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 (NCT06147986) is a Phase 2 interventional studying ST Elevation Myocardial Infarction, sponsored by Ever Supreme Bio Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against ST Elevation Myocardial Infarction and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 41 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 LVEF ≥ 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 (FEV1) \> 50% predicted and peripheral artery oxygen saturation ≥ 95% at room air 8. Adequate hematopoietic function at the screening and before administration of study medication: - platelet count at least 100,000 counts/μL. - blood count (hemoglobin) at least 8 g/dL. - PT, APTT ≤ 1.5X upper limit of normal (ULN). 9. Has signed and dated willing to sign a consent form ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 LVEF ≥ 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 (FEV1) \> 50% predicted and peripheral artery oxygen saturation ≥ 95% at room air 8. 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). 9. Has signed and dated informed consent 10. 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 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 autoimmune conditions, or receiving immunosuppressive treatments within 12 weeks prior to the study intervention 6. Presence of any active malignancy 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 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 8. 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 9. With uncontrolled diabetes mellitus (blood glucose level \> 200 mg/dL or HbA1c ≥ 8.5%) 10. Participation in a clinical trial of an investigational product within 3 months prior to Screening Visit 11. Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product 12. 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 13. Subjects not suitable to participate the trial as judged by the Investigator(s)

Treatments Being Tested

BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells

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

OTHER

Control group

Standard-of-care for STEMI

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

China Medical University Hospital
Taichung, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06147986), the sponsor (Ever Supreme Bio Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06147986 clinical trial studying?

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 subjec… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06147986?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06147986?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06147986. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06147986. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.