Phase 1Recruiting
A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy (HEART-1)
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
- Sponsor
- HieraBio Inc. (Government)
- Enrolment
- 12 planned
- Conditions
- Ischemic Cardiomyopathy
- Interventions
- HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells); HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)
- Ages
- adults, older adults
- Registry
- NCT07861035
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Adverse event, AE
- DLT, Dose Limiting Toxicity
History
Study completion expected
Primary completion expected
Registered
Started