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) (HECTOR)

  • STATUS
    Recruiting
  • End date
    Oct 18, 2025
  • participants needed
    18
  • sponsor
    Joseph C. Wu
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Updated on 18 October 2022
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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).

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.

Details
Condition Chronic Ischemic Left Ventricular Dysfunction
Treatment Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells, Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
Clinical Study IdentifierNCT05068674
SponsorJoseph C. Wu
Last Modified on18 October 2022

Eligibility

 Yes No Not Sure

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
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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