A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy (HEART-1)

September 30, 2026 updated by: HieraBio Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participation in this study will last approximately 12 months following treatment. Prior to surgery, potential participants will undergo a screening visit to confirm eligibility. Screening assessments will include a physical exam, review of medical history and current medications, blood tests, electrocardiogram (ECG), echocardiogram, and cardiac MRI. Eligible participants will be admitted to the hospital 1 to 2 days before their scheduled CABG surgery for final pre-operative assessments.

On the day of surgery, CABG will be performed as planned. Once the bypass procedure is complete and before chest closure, HB1011 will be injected directly into the damaged heart muscle through a transepicardial approach. Participants will be assigned to either a low-dose or high-dose group following a sequential dose-escalation design, with safety carefully monitored at each stage before proceeding to the next dose level. After receiving the injections, participants will remain hospitalized for post-operative monitoring and observation.

Following discharge, participants will return for scheduled outpatient visits at 1, 3, 6, 9, and 12 months after surgery. At each visit, safety and tolerability will be assessed through physical exams, blood tests, and cardiac evaluations. Exploratory assessments of heart function, including echocardiogram and cardiac MRI, will be performed at selected time points to evaluate any changes over the course of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Low Dose of HB1011

Drug: HB1011 (0.5 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG
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.
Experimental: Group 2: High Dose of HB1011

Drug: HB1011 (1.0 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse event, AE
Time Frame: 12 Months

Treatment-Emergent Adverse Event, TEAE, Adverse Drug Reaction, ADR, Serious Adverse Event, SAE, Serious Adverse Drug Reaction, SADR, Suspected Unexpected Serious Adverse Drug Reaction, SUSAR
12 Months
DLT, Dose Limiting Toxicity
Time Frame: 12 Months

DLT, Dose Limiting Toxicity
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in LVEF by Echocardiography
Time Frame: Baseline, 3, 6, and 12 months post-treatment

Change in left ventricular ejection fraction (LVEF) from baseline as measured by echocardiography
Baseline, 3, 6, and 12 months post-treatment
Change in LVEF by Cardiac MRI
Time Frame: Baseline, 6, and 12 months post-treatment

Change in LVEF from baseline as measured by cardiac MRI
Baseline, 6, and 12 months post-treatment
Change in Infarct Scar Size (ISS)
Time Frame: Baseline, 6, and 12 months post-treatment

Change in infarct scar size from baseline as measured by delayed contrast-enhanced cardiac MRI
Baseline, 6, and 12 months post-treatment
Regional Wall Motion Abnormality (RWMA)
Time Frame: Baseline, 6, and 12 months post-treatment

Change in regional wall motion abnormality at the site of HB1011 injection as assessed by echocardiography
Baseline, 6, and 12 months post-treatment
NYHA Functional Classification
Time Frame: Baseline, 1, 3, 6, 9, and 12 months post-treatment

Change in NYHA functional class based on patient-reported activity limitation (Improved / Unchanged / Worsened)
Baseline, 1, 3, 6, 9, and 12 months post-treatment
MACCE Incidence
Time Frame: Within 12 months post-treatment

Composite rate of major adverse cardiac and cerebrovascular events including death, hospitalization for heart failure, non-fatal recurrent MI, target vessel revascularization, and stroke
Within 12 months post-treatment
Mortality
Time Frame: Within 12 months post-treatment

Proportion of patients who died following CABG surgery, categorized as early mortality (within 30 days), in-hospital mortality, and late mortality (after 30 days)
Within 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HieraBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HBC-1011-CTP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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