Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Myocardial Infarction

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    8
  • sponsor
    Ever Supreme Bio Technology Co., Ltd.
Updated on 15 February 2022

Summary

This study is a first-in-human assessment of safety of using UCMSC in patients with AMI via a combination of IC and IV stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IC and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.

Description

Cardiovascular disease is the leading cause of death in the developed world, with global deaths due to coronary artery disease estimated to increase from 7.3 million in 2008 to 25 million by 2020 WHO, 2011.

The leading symptom that initiates the diagnostic and therapeutic cascade in patients with suspected acute coronary syndromes (ACS) is chest pain.

Most patients will ultimately develop an ST elevation myocardial infarction (STEMI). The mainstay of treatment in these patients is immediate reperfusion by primary angioplasty or fibrinolytic therapy. Basically, STEMI comprises approximately 25% to 40% of myocardial infarction (MI) presentations. Acute STEMI is a major cause of morbidity, mortality, and disability.

This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for AMI and stroke. The rats with coronary artery ligation receiving intravenous injection of UMSC01 showed significantly improved cardiac function.

Details
Condition Acute Myocardial Infarction
Treatment Allogeneic umbilical cord mesenchymal stem cells
Clinical Study IdentifierNCT04056819
SponsorEver Supreme Bio Technology Co., Ltd.
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients are aged 20, <76 years old on date of consent
Patients who presented typical ischemic chest pain within 12 h after symptoms onset and are diagnosed first acute STEMI according to the 2013 American College of Cardiology (ACC) Foundation/American Heart Association (AHA) guideline for the Management of STEMI
Patients who 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
Patients who undergo successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow 2) with placement of an intracoronary stent have a patent infarct-related artery suitable for cell infusion to the target area of abnormal wall motion following myocardial infarction
Patients who have left ventricular ejection fraction (LVEF) 30% and < 50% diagnosed by echocardiogram
Patients are willing to sign informed consent or assent by the next of kin
Patients who have stable vital signs for at least 48 hours, defined as normal respiration, afebrile, systolic pressure 90 mmHg and < 180 mmHg, heart rate > 50/min and <110/min
Adequate pulmonary function test defined as a force expiratory volume 1s (FEV1) > 50% predicted and peripheral artery oxygen saturation 95% at room air
All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) shown below, for at least 4 weeks after UMSC01 treatment
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)
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
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
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

Patients with cardiogenic shock (defined as systolic blood pressure < 80 mmHg requiring vasopressors, intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO)
Patients who have severe aortic stenosis or regurgitation according to the recommendation of the 2014 ACC/AHA guideline for the Management of Patients with Valvular Heart Disease
Patients who have severe mitral stenosis or regurgitation according to the recommendation of 2014 ACC/AHA guideline for the Management of Patients with Valvular Heart Disease
Patients who need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery
Patients who have immuno-compromised condition, or is with known clinically significantly autoimmune conditions or is receiving immunosuppressive treatments
Patients who are unable to undergo cardiac magnetic resonance imaging (CMRI) scans for any reason
Patients 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) < 30 mL/min
For patients with diabetes mellitus: patients with uncontrolled diabetes mellitus (fasting sugar level > 250 mg/dL)
Patients who have medical history of malignant tumor or other clinically significant cardiovascular diseases that will confound the evaluation of this study
Patients who participated other clinical trial within last 3 months
Female patient who is pregnant, lactating or with child-bearing potential but not practicing effective contraceptive method(s)
Patients not suitable to participate the trial as judged by the Investigator(s)
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