Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
NCT05647213
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Univentricular Heart
- Congenital Heart Disease
- Heart Failure NYHA Class III
- Heart Failure NYHA Class IV
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- HeartWorks, Inc.
- Last updated on ClinicalTrials.gov
- March 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Minnesota · 1
- Mayo Clinic · Rochester, MN
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.