Ischemic cardiomyopathy occurs when the heart muscle is permanently weakened due to blocked coronary arteries that limit blood flow. Current treatments, including medications and lifestyle changes, can manage symptoms but cannot restore the damaged heart muscle.
Stem cell therapy offers a promising approach to repair and regenerate damaged heart tissue. This study will evaluate the safety and tolerability of HB1011 - an allogeneic myocardium-derived mesenchymal stem cell therapy - in patients with ischemic cardiomyopathy who are undergoing coronary artery bypass grafting (CABG) surgery. HB1011 will be injected directly into the damaged heart muscle during the CABG procedure. Participants will receive different doses of HB1011, starting from a lower dose and gradually increasing, to identify the safest and most appropriate dose for future studies.
Scheduled to undergo coronary artery bypass grafting (CABG) surgery
Left ventricular ejection fraction (LVEF) ≤ 40%
Age 19 to 85 years, male or female
Diagnosed with ischemic cardiomyopathy
New myocardial infarction within 28 days prior to screening, or unstabilized cardiac enzyme levels at screening
Participation in another clinical trial involving an investigational drug or device within 6 months prior to screening
Contraindication to cardiac MRI (e.g., pacemaker, severe claustrophobia)
Pregnant, breastfeeding, or unwilling to use adequate contraception during the study
Sequential
HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)
Biological/VaccineBiological: Lower dose of HB1011 injection Participants will receive between 5 intramyocardial injections of 1 million allogeneic myocardium-derived mesenchymal stem cells for a total of 0.5 x 10\^7 cells. The injections will be administered following completion of CABG surgery.
HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)
Biological/VaccineBiological: Higher dose of HB1011 injection Participants will receive between 5 intramyocardial injections of 2 million allogeneic myocardium-derived mesenchymal stem cells for a total of 1.0 x 10\^7 cells. The injections will be administered following completion of CABG surgery.
Adverse event, AE
Treatment-Emergent Adverse Event, TEAE, Adverse Drug Reaction, ADR, Serious Adverse Event, SAE, Serious Adverse Drug Reaction, SADR, Suspected Unexpected Serious Adverse Drug Reaction, SUSAR
DLT, Dose Limiting Toxicity
DLT, Dose Limiting Toxicity
Change in LVEF by Echocardiography
Change in left ventricular ejection fraction (LVEF) from baseline as measured by echocardiography
Change in LVEF by Cardiac MRI
Change in LVEF from baseline as measured by cardiac MRI
Change in Infarct Scar Size (ISS)
Change in infarct scar size from baseline as measured by delayed contrast-enhanced cardiac MRI
Regional Wall Motion Abnormality (RWMA)
Change in regional wall motion abnormality at the site of HB1011 injection as assessed by echocardiography
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