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

Individuals may be considered eligible for enrollment for Part I of this study (Skin Punch Biopsy) if in the best judgment of the Principal Investigator they will meet eligibility criteria outlined below at the time it is determined acceptable investigational product is available for administration (approximately 9 months post skin punch biopsy). Inclusion and exclusion criteria apply to both the treatment and control arms of the study unless otherwise specified. Inclusion Criteria Individuals who meet all the following criteria are eligible for enrollment as study participants: * Age 18 to 40 years old * Subject must be able to understand and provide informed consent. * Univentricular congenital heart disease. * End-stage systolic heart failure, defined as Class IV according to New York Heart Association (NYHA) with abnormal visually estimated ejection fraction below 40%. * Prognosis of 1 to 1.5 years survival at time of skin biopsy. * The patient falls into one of the following categories: * Currently listed for heart transplantation at an accredited program in the US but has an expected waiting time for a suitable organ that is likely longer than anticipated life-expectancy. * Has been denied access to a heart transplantation at an accredited US institution. * Is currently on or planning to be on mechanical support as destination therapy. * All guideline directed therapy available to the subject has been maximized, for a minimum of 3 months prior to enrollment. *…