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

Launched by JOSEPH C. WU · Sep 24, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment using heart cells derived from human embryonic stem cells to help improve heart function and survival in patients suffering from chronic left ventricular dysfunction, which can happen after a heart attack. The goal is to see if this cell therapy can help people whose heart isn't pumping effectively due to damage from a previous heart attack.

To participate in the trial, individuals need to be between the ages of 21 and 80 and have been diagnosed with chronic left ventricular dysfunction caused by a heart attack. They should also have certain heart-related symptoms and meet specific health criteria. Participants can expect to receive this innovative treatment and be closely monitored for its effects on their heart function. It’s important to note that there are specific health conditions that would prevent someone from joining the trial, such as severe kidney issues or recent heart problems. Overall, this study aims to investigate a promising new approach to treating heart conditions that significantly impact quality of life.

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Eligibility criteria

• 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