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Study identifier: NCT05647213 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Condition: Univentricular Heart · Congenital Heart Disease · Heart Failure NYHA Class III  ·  Sponsor: HeartWorks, Inc.

PhasePhase 1
Planned participants50
Who can joinAll sexes, 18 Years to 40 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Adam Armstrong  ·  1-(507) 577-1764  ·  adam@webuildhearts.org

Always discuss trial participation with your own doctor first.

Locations (1)

Mayo ClinicRochester, Minnesota, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05647213