Recruiting

Phase 1

Cardiomyocyte TherapyHuman Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction

Sponsor:

Joseph C. Wu

Code:

NCT05068674

Conditions

Chronic Ischemic Left Ventricular Dysfunction

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells

Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells

Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells

Study Details

Brief 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).

Conditions

Chronic Ischemic Left Ventricular Dysfunction

Study ID

NCT05068674

Start date

Mar 22, 2022

Status verified date

Sep, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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%.
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.

Exclusion Criteria:

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.
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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cohort 1

Low dose (50M cells)

active comparator: Cohort 2

Medium dose (150M cells)

active comparator: Cohort 3

High dose (300M cells)

Interventions

Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells

50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.

Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells

150M cells delivered in a dose of 15M cells per injection over 10 injections

Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells

300M cells delivered in a dose of 30M per injection over 10 injections

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 ]

Central Contacts and Locations

Central contacts

Joseph C. Wu, MD, PhD

(650) 736-2246 joewu@stanford.edu

Evgenios Neofytou, MD

(650) 736-2246 neofytou@stanford.edu

Locations

Stanford Hospital and Clinics

Recruiting

Palo Alto, California, United States, 94305

More Information

Sponsor

Joseph C. Wu

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joseph C. Wu on 2025-09-29.