Skin Punch Biopsy Sample Collection Study for Adults with Congenital Heart Disease to Support Future Clinical Trials

What this Trial Is About

This research aims to collect skin punch biopsy samples from adults with congenital heart disease to prepare for future treatments. The study focuses on clinical readiness to help reduce manufacturing time for induced pluripotent stem cells when patients qualify for a separate interventional treatment. It is an observational study sponsored by HeartWorks, Inc., involving participants diagnosed with congenital heart disease or congenital heart defect. Participants will undergo skin punch biopsy sample collection to facilitate the manufacturing process of stem cells. This study does not involve treatment administration but supports future therapeutic protocols by preparing patient samples. There are no additional interventions or comparison groups as this is an observational study focused on sample collection. During the study, researchers will monitor the successful manufacturing of induced pluripotent stem cells over 12 months. Participants will provide skin samples and may undergo assessments related to their eligibility for future clinical trials. The study lasts until July 2027, with no medication or treatment given, focusing on preparing samples for subsequent therapeutic use.

Clinical Readiness Skin Punch Biopsy Sample Collections