NCT07861035RecruitingPhase 1
A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- Jun 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- HieraBio Inc.
- Diseases
- Heart failure
- NCT number
- NCT07861035
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From Jun 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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%
Other illness
- 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
Lab values
- Severe chronic renal impairment (eGFR \< 30 mL/min/1.73m²), renal replacement therapy, or significant hepatic disease
- HbA1c \> 10% in patients with diabetes
Other
- Pregnant, breastfeeding, or unwilling to use adequate contraception during the study
- Hemodynamically unstable patients
Who the study is looking for
- 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
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.