Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

This first-in-human study tests whether sheets of engineered heart muscle — made from stem cells reprogrammed from a patient's own cells (called iPSC-derived engineered human myocardium) — can be surgically attached to the outside of a failing heart to help it pump better. It is designed for people with advanced heart failure whose heart does not respond adequately to standard medications. **You may be eligible if...** - You are between 18 and 80 years old - You have symptomatic heart failure (NYHA class II-IV) with significantly reduced heart pumping function (ejection fraction 35% or lower) - You are on guideline-recommended heart failure medications - You have been hospitalized for heart failure in the past year - You have an area of the heart with weak or abnormal movement, suitable for the implant - You are scheduled for heart surgery (such as bypass or valve repair) or meet other surgical criteria **You may NOT be eligible if...** - You have had a stroke - You have terminal kidney or liver failure - You have active unresolved cancer, HIV, or hepatitis B/C (which would prevent immune-suppressing drugs needed after implant) - You have hypertrophic cardiomyopathy (a different type of heart condition) - You are pregnant or breastfeeding - You have a known alcohol or drug abuse problem Talk to your doctor to see if this trial is right for you.