Ischemic CardiomyopathyPhase 1HEART-1NCT07861035
A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011) in Patients With Ischemic Cardiomyopathy
A Phase 1 study testing HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells) in people with Ischemic Cardiomyopathy, run by HieraBio Inc. at 1 site in South Korea.
Trial summary
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 more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2026to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
HyoungWoo Chang, Professor, +82-31-787-7139, chang.hyoungwoo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)
- Keywords
- Ischemic cardiomyopathy, Allogeneic Mesenchymal Stem Cells, Myocardium-derived Stem Cells, Cardiac Stem Cell, Coronary Artery Bypass Grafting, CABG, Intramyocardial, Transepicardial, Cell-based Therapy, Phase I Clinical Trial, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)Biological
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.
HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Low Dose of HB1011 | Experimental | Drug: HB1011 (0.5 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG Receives: Biological: HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells) |
| Group 2: High Dose of HB1011 | Experimental | Drug: HB1011 (1.0 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG Receives: Biological: HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event, AE
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
Measured: 12 Months
DLT, Dose Limiting Toxicity
DLT, Dose Limiting Toxicity
Measured: 12 Months
Secondary outcomes (7)
Change in LVEF by Echocardiography
Change in left ventricular ejection fraction (LVEF) from baseline as measured by echocardiography
Measured: Baseline, 3, 6, and 12 months post-treatment
Change in LVEF by Cardiac MRI
Change in LVEF from baseline as measured by cardiac MRI
Measured: Baseline, 6, and 12 months post-treatment
Change in Infarct Scar Size (ISS)
Change in infarct scar size from baseline as measured by delayed contrast-enhanced cardiac MRI
Measured: Baseline, 6, and 12 months post-treatment
Regional Wall Motion Abnormality (RWMA)
Change in regional wall motion abnormality at the site of HB1011 injection as assessed by echocardiography
Measured: Baseline, 6, and 12 months post-treatment
NYHA Functional Classification
Change in NYHA functional class based on patient-reported activity limitation (Improved / Unchanged / Worsened)
Measured: Baseline, 1, 3, 6, 9, and 12 months post-treatment
MACCE Incidence
Composite rate of major adverse cardiac and cerebrovascular events including death, hospitalization for heart failure, non-fatal recurrent MI, target vessel revascularization, and stroke
Measured: Within 12 months post-treatment
Mortality
Proportion of patients who died following CABG surgery, categorized as early mortality (within 30 days), in-hospital mortality, and late mortality (after 30 days)
Measured: Within 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start23 Jun 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HieraBio Inc.
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861035
- Sponsor's protocol ID
- HBC-1011-CTP-001
- Acronym
- HEART-1
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07861035
- Acronym / sponsor ID
- HEART-1 / HBC-1011-CTP-001
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Ischemic cardiomyopathy, Allogeneic Mesenchymal Stem Cells, Myocardium-derived Stem Cells, Cardiac Stem Cell, Coronary Artery Bypass Grafting, CABG, Intramyocardial, Transepicardial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HieraBio Inc.Other government
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Low Dose of HB1011 | Experimental | Biological: HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)Drug: HB1011 (0.5 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG |
| Group 2: High Dose of HB1011 | Experimental | Biological: HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells)Drug: HB1011 (1.0 × 10⁷ cells), transepicardial intramyocardial injection at the time of CABG |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group 1: Low Dose of HB1011 |
| 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. | Biological | Group 2: High Dose of HB1011 |
Primary outcome
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
DLT, Dose Limiting Toxicity
Time frame: 12 Months
DLT, Dose Limiting Toxicity
7 secondary outcomes
Change in LVEF by Echocardiography
Time frame: 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 Infarct Scar Size (ISS)
Time frame: Baseline, 6, and 12 months post-treatment
Regional Wall Motion Abnormality (RWMA)
Time frame: Baseline, 6, and 12 months post-treatment
NYHA Functional Classification
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-treatment
MACCE Incidence
Time frame: Within 12 months post-treatment
Mortality
Time frame: Within 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB1011 (Allogeneic Myocardium-derived Mesenchymal Stem Cells) in people with Ischemic Cardiomyopathy, run by HieraBio Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HeeJung Kim, CTO (+82-711-7734, hierabio@hierabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event, AE (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.