HB1011: a first-in-human test of heart-derived stem cells injected during bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study to assess the safety and tolerability of HB1011, allogeneic myocardium-derived mesenchymal stem cells, injected directly into damaged heart muscle during CABG surgery. Participants will receive escalating doses in sequential cohorts, with close safety monitoring before advancing to the next dose level. The treatment window includes pre-surgical screening, the CABG procedure with transepicardial injection, in-hospital postoperative observation, and follow-up visits at 1, 3, 6, 9, and 12 months to evaluate safety and preliminary signals of heart function. Exploratory assessments, such as echocardiography and cardiac MRI, will help gauge any functional changes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: HeeJung Kim, CTO
• Email: hierabio@hierabio.com
• Phone: +82-711-7734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.