About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- iPSC-CL