drugset / Trial / NCT05647213

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

NCT05647213 ↗

Phase 1 Recruiting 50 enrolled HeartWorks, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-03
Primary completion
2027-09
Completion
2029-02

Drugs

EvaluationDrugModalityDoseRoute
Subject iPSC-CL Cell therapy — —