RecruitingPhase 1NCT05647213

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

Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease

Sponsor

HeartWorks, Inc.

Enrollment

50 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Congenital Heart Disease Heart Failure NYHA Class III Heart Failure NYHA Class IV Univentricular Heart

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.

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether stem cells made from a patient's own skin can be turned into heart cells to potentially treat congenital heart disease. The first phase involves only a small skin biopsy to collect cells for future use — no experimental treatment is given yet. **You may be eligible if...** - You have congenital heart disease (a heart condition present from birth) - You or your guardian are willing to provide a small skin biopsy - Your doctors believe you may be suitable for an experimental heart cell therapy in the future **You may NOT be eligible if...** - You have conditions that would make cell collection or future therapy unsafe - You are unwilling or unable to consent to the biopsy procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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