Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Exclusion Criteria

• •No available autologous iPSC-CL as defined by the manufacturer's release criteria. (This applies to Part II of the study and applies to the treatment arm only.)
• •History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation or escalation of medications.
• •Heart failure with preserved ejection fraction.
• •Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease, refractory anemia).
• •QTc greater than 500 ms.
• •Stage III or higher chronic kidney disease.
• •History of liver cirrhosis.
• •History of coronary artery disease.
• •Uncontrolled diabetes mellitus.
• •Any history of cancer.
• •Contraindication for use of amiodarone for up to 3 months (treatment arm only).
• •Contraindication for insertion of Insertable Cardiac Monitor.
• •Contraindication for placement of LifeVest cardioverter defibrillator.
• •Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.
• •Obesity with BMI greater than 30.
• •Current alcohol or drug abuse precluding heart transplantation.
• •Active infection requiring ongoing treatment.
• •Contraindication to anesthesia.
• •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality of the data obtained from the study.
• •Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• •History of non-compliance.
• •Inability to be accompanied around the clock for any part of the first 3 weeks post product administration.
• •Uncontrolled depression.
• •Denied heart transplant due to social determinants.
• •Current participation in another cardiac interventional clinical trial that could confound the results of this study.
• •Previous heart transplant.