Testing the safety of HB1011 stem cells for heart muscle damaged by blocked arteries

Trial details

Who runs it

HieraBio Inc.

Trial code

NCT07861035

Record updated

6 October 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; Systemic immunosuppressive therapy at protocol-defined high doses, or high-dose short-term steroid therapy within 4 weeks prior to treatment; Requirement for concomitant major cardiac or aortic procedures at the time of CABG (e.g., valve repair/replacement, aortic surgery); Panel reactive antibody (PRA) Class I or II ≥ 50%; Contraindication to cardiac MRI (e.g., pacemaker, severe claustrophobia); 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; Suspected active infection within 48 hours before surgery; Life expectancy less than 1 year due to non-cardiac conditions; Severe pulmonary hypertension or conditions requiring resting oxygen therapy; 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; Severe chronic renal impairment (eGFR < 30 mL/min/1.73m²), renal replacement therapy, or significant hepatic disease; HbA1c > 10% in patients with diabetes; Pregnant, breastfeeding, or unwilling to use adequate contraception during the study; Hemodynamically unstable patients.

ClinicalTrials.gov NCT07861035