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RECRUITING

NCT07861035

PHASE1

A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy

Sponsor: HieraBio Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective, Open-label, Dose-escalation, Single-center, Non-randomized Phase I Study to Evaluate Safety and Tolerability of Allogeneic Myocardium-derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy

Key Details

Gender

All

Age Range

19 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-23

Completion Date

2028-01-31

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Ischemic Cardiomyopathy

Interventions

BIOLOGICAL

HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)

Biological: 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.

BIOLOGICAL

HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)

Biological: 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.

Inclusion Criteria: * 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 * NYHA functional Class II-IV at screening * Ability to understand the study and willing to provide written informed consent Exclusion Criteria: * 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 * History of malignancy within 5 years, severe allergic reaction, prior cardiac surgery (including CABG), stroke within 3 months, or incomplete recovery from major surgery within 12 weeks * Significant comorbidities at screening, including severe ventricular arrhythmia, uncontrolled atrial fibrillation, severe or unstable COPD, congenital heart disease, active viral or severe infection, autoimmune disease, or active tuberculosis * Active hepatitis B, hepatitis C, or HIV infection * Systemic immunosuppressive therapy at protocol-defined high doses, or high-dose short-term steroid therapy within 4 weeks prior to treatment * Suspected active infection within 48 hours before surgery * Life expectancy less than 1 year due to non-cardiac conditions * Requirement for concomitant major cardiac or aortic procedures at the time of CABG (e.g., valve repair/replacement, aortic surgery) * Severe chronic renal impairment (eGFR \< 30 mL/min/1.73m²), renal replacement therapy, or significant hepatic disease * Hemodynamically unstable patients * Severe pulmonary hypertension or conditions requiring resting oxygen therapy * Panel reactive antibody (PRA) Class I or II ≥ 50% * HbA1c \> 10% in patients with diabetes * Severe peripheral arterial disease with rest pain, ischemic ulcer, or gangrene * Hypersensitivity to bovine-derived proteins * Any other condition deemed unsuitable for participation by the investigator

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea