Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
HeartWorks, Inc.
Abstract
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects. Phase: PHASE1 Status: RECRUITING Conditions: Univentricular Heart; Congenital Heart Disease; Heart Failure NYHA Class III; Heart Failure NYHA Class IV Interventions: iPSC-CL