Chronic Ischemic Left Ventricular DysfunctionPhase 1HECTORNCT05068674
Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction
A Phase 1 study testing Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells and Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells in people with Chronic Ischemic Left Ventricular Dysfunction, run by Joseph C. Wu at 1 site in United States.
Trial summary
This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Ischemic Left Ventricular Dysfunction
- What is being tested?
- Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells and Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to Oct 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 21 and < 80 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe hypokinesis.
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensinconverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical indication precluding use of one or both of these agents, the patient must have been on a stable dose of a clinically appropriate agent for 1 month or within no more than doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months.
- Left ventricular ejection fraction below 40%.
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- Class II/III NYHA symptoms of heart failure within the 6 months prior to baseline testing.
- Hospitalization in the past 6 months or NT pro-BNP > 1200 pg/mL, or >1600 pg/mL if atrial fibrillation was present.
- Automated implantable cardioverter-defibrillator (AICD) in place.
Who cannot join
- Have a baseline glomerular filtration rate < 35 ml/min/1.73 m2
- Have a known, serious radiographic contrast allergy.
- Have a prosthetic aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- Have evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second- or third-degree heart block in the absence of a functioning pacemaker) or QTc interval > 550 ms on screening ECG.
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- AICD firing in the past 60 days prior to enrollment.
- Be eligible for or require coronary artery revascularization.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/µl, or platelet values < 100,000/µl without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Have a coagulopathy (INR > 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment.
- Have known allergies to penicillin or streptomycin.
- Be an organ transplant recipient.
- Have a history of organ or cell transplant rejection.
- Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease-free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum-positive for HIV, hepatitis BsAg, or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be a female patient who is pregnant, nursing, or have child-bearing potential but is not using effective birth control.
- Tested positive for SARS-CoV-2 within the last 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Hospital and Clinics
Palo Alto, California, 94305
About this study
Official title: A Phase I, Randomized Pilot Study of Human Embryonic Stem Cell-Derived Cardiomyocytes (hESC-CMs) in PaTients With ChrOnic Ischemic Left VentRicular Dysfunction Secondary to Myocardial Infarction (HECTOR)
This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).
Read the detailed description
The phase I dose-escalation pilot study is intended as an initial safety assessment to establish the MTD prior to the phase II randomized, double-blinded, placebo-controlled study. An estimated eighteen (18) patients in phase I who are scheduled to undergo cardiac catheterization and have met all inclusion/exclusion criteria will be enrolled.
- Being tested
- Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cellsDrug
Also called Human ESC-CMs
50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cellsDrug
Also called Human ESC-CMs
150M cells delivered in a dose of 15M cells per injection over 10 injections
Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cellsDrug
Also called Human ESC-CMs
300M cells delivered in a dose of 30M per injection over 10 injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Low dose (50M cells) Receives: Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells |
| Cohort 2 | Active comparator | Medium dose (150M cells) Receives: Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells |
| Cohort 3 | Active comparator | High dose (300M cells) Receives: Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs)
The primary endpoints are safety and feasibility. The feasibility of preparing and delivering the study product, as well as collecting cardiac MRI variables in subjects will be assessed.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start22 Mar 2022
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic Left Ventricular DysfunctionStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Phase I will be a standard 3+3 dose-escalation study to evaluate 3 doses of allogeneic hESC-CMs
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph C. Wu
- Sponsor type
- University, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor-investigator, Joseph C. Wu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068674
- Sponsor's protocol ID
- 60978
- Acronym
- HECTOR
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized Pilot Study of Human Embryonic Stem Cell-Derived Cardiomyocytes (hESC-CMs) in PaTients With ChrOnic Ischemic Left VentRicular Dysfunction Secondary to Myocardial Infarction (HECTOR)
- ClinicalTrials.gov ID
- NCT05068674
- Acronym / sponsor ID
- HECTOR / 60978
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Joseph C. WuUniversity, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Oct 2021 (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.
This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).
Detailed description
The phase I dose-escalation pilot study is intended as an initial safety assessment to establish the MTD prior to the phase II randomized, double-blinded, placebo-controlled study. An estimated eighteen (18) patients in phase I who are scheduled to undergo cardiac catheterization and have met all inclusion/exclusion criteria will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase I will be a standard 3+3 dose-escalation study to evaluate 3 doses of allogeneic hESC-CMs
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cellsLow dose (50M cells) |
| Cohort 2 | Active comparator | Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cellsMedium dose (150M cells) |
| Cohort 3 | Active comparator | Drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cellsHigh dose (300M cells) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be ≥ 21 and < 80 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe hypokinesis.
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensinconverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical indication precluding use of one or both of these agents, the patient must have been on a stable dose of a clinically appropriate agent for 1 month or within no more than doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months.
Key exclusion criteria (21 listed)
- Have a baseline glomerular filtration rate < 35 ml/min/1.73 m2
- Have a known, serious radiographic contrast allergy.
- Have a prosthetic aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
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 |
|---|---|---|
| Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cellsAlso: Human ESC-CMs50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections. | Drug | Cohort 1 |
| Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cellsAlso: Human ESC-CMs150M cells delivered in a dose of 15M cells per injection over 10 injections | Drug | Cohort 2 |
| Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cellsAlso: Human ESC-CMs300M cells delivered in a dose of 30M per injection over 10 injections | Drug | Cohort 3 |
Primary outcome
The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs)
Time frame: 3 Years
The primary endpoints are safety and feasibility. The feasibility of preparing and delivering the study product, as well as collecting cardiac MRI variables in subjects will be assessed.
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 29 Sep 2025.
- 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 Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells and Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells in people with Chronic Ischemic Left Ventricular Dysfunction, run by Joseph C. Wu at 1 site in United States.
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 9 inclusion and 21 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 29 Sep 2025. 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 United States. 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 Joseph C. Wu, MD, PhD ((650) 736-2246, joewu@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs) (time frame: 3 Years). 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 29 Sep 2025.