Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
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 a
| Condition(s) | Univentricular Heart, Congenital Heart Disease, Heart Failure NYHA Class III, Heart Failure NYHA Class IV |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 H |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Lead sponsor | HeartWorks, Inc. |
| Locations | Rochester, Minnesota, United States |
| Start date | 2023-02-03 |
| NCT ID | NCT05647213 |
| Official listing | https://clinicaltrials.gov/study/NCT05647213 |