None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : After Coronary Artery Bypass Grafting surgery (CABG), a single administration of the treatment is given to the myocardium via the left ventricular epicardial route (tra
Sponsors
HieraBio lnc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Individuals scheduled for Coronary Artery Bypass Grafting surgery (CABG) (2) Left ventricular ejection fraction (LVEF) = 40% as measured by echocardiography (3) Male and female individuals aged 19 to 85 years (4) At least 3 months have passed since the most recent myocardial infarction at the time of screening (individuals in a chronic post-myocardial infarction state) (5) Patients classified as NYHA Class II–IV at the time of screening (6) Individuals who fully understand the clinical trial and voluntarily decide to participate, having provided written informed consent
Exclusion criteria
Exclusion criteria: Individuals who meet one or more of the following criteria will be excluded: (1) Individuals who have participated in another clinical trial within 6 months or within five half-lives (whichever is longer) prior to screening, and have received clinical trial drugs or applied clinical trial medical devices. (2) Individuals for whom cardiac magnetic resonance imaging (cardiac MRI) is not possible (e.g., those with a pacemaker, those who cannot tolerate MRI due to claustrophobia, etc.). (3) Pregnant or breastfeeding women, or women of childbearing potential who do not plan to use an appropriate contraceptive method* during the clinical trial, or men who do not intend to use contraception. *Hormonal contraceptives, intrauterine devices (IUD), intrauterine systems (IUS), surgical sterilization procedures (vasectomy, tubal ligation, etc.). (4) Individuals with the following medical or surgical history at the time of screening: Malignant tumors within the past 5 years (except for those with cured cervical cancer or squamous cell carcinoma for more than 3 years). Current active malignancy. Surgical history within the past 12 weeks (excluding local surgery). History of severe allergic reactions. Previous heart surgery (including Coronary Artery Bypass Grafting surgery (CABG)). History of stroke within the past 3 months. (5) Individuals with the following conditions at the time of screening: Severe ventricular arrhythmia requiring treatment. Chronic atrial fibrillation. Significant cognitive impairment. Congenital heart disease. Severe chronic obstructive pulmonary disease (COPD). Acute viral infections or severe infections. Active hepatitis B (e.g., HBsAg positive with detectable HBV DNA) or hepatitis C (e.g., Anti-HCV positive with detectable HCV RNA [qualitative]). HIV-positive. Connective tissue diseases. Active tuberculosis. Autoimmune diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or psoriatic arthritis. (6) Individuals using immunosuppressive drugs (e.g., prednisone, cyclophosphamide, etanercept, etc.). (7) Individuals suspected of having an active infection within 48 hours prior to surgery (e.g., body temperature >38°C and white blood cell count >10,000/mm³). (8) Individuals with a life expectancy of less than 1 year due to non-cardiac diseases. (9) Individuals requiring urgent vascular revascularization. (10) Individuals requiring additional surgical procedures during CABG surgery (e.g., valve repair or replacement, aortic surgery, etc.). (11) Individuals with severe chronic renal dysfunction (requiring hemodialysis/peritoneal dialysis), liver disease (e.g., cirrhosis, chronic hepatitis, serum aminotransferase levels >3 times the upper limit of normal), cerebrovascular disease requiring carotid endarterectomy, peripheral artery disease (claudication as a major limiting factor), or other conditions that may increase the risk of complications during the first 6 months after the procedure, as determined by the attending cardiologist or thoracic surgeon. (12) Individuals with the following abnormal laboratory results at the time of screening: Cardiac-specific Troponin I =4 ng/mL. Glomerular Filtration Rate (GFR) 1.5 or Platelet Count 3.0 x ULN (Upper limit of normal). (13) Type 1 or Type 2 diabetes with HbA1c >10%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Dose Limiting Toxicity;Vital signs;Laboratory test results ;ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction (Echocardiography);Left Ventricular Ejection Fraction (Cardiac MRI);?Infarct Scar Size;Regional wall motion abnormality;Major adverse cardiovascular and cerebrovascular Events (MACCE);Change in NYHA classification | — |
Countries
Korea, Republic of
Contacts
Public ContactHyoung Woo Chang
Seoul National University Bundang Hospital
Outcome results
None listed