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Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05647213•HeartWorks, Inc.

View on ClinicalTrials.gov

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

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals who meet all the following criteria are eligible for enrollment as study participants:
•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%.
•Prognosis of 1 to 1.5 years survival at time of skin biopsy.
•The patient falls into one of the following categories:
•* Currently listed for heart transplantation at an accredited program in the US but has an expected waiting time for a suitable organ that is likely longer than anticipated life-expectancy.
•* Has been denied access to a heart transplantation at an accredited US institution.
•* Is currently on or planning to be on mechanical support as destination therapy.
+2 more criteria

Exclusion Criteria

•No available autologous iPSC-CL as defined by the manufacturer's release criteria. (This applies to Part II of the study and applies to the treatment arm only.)
•History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation or escalation of medications.
•Heart failure with preserved ejection fraction.
•Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease, refractory anemia).
•QTc greater than 500 ms.
•Stage III or higher chronic kidney disease.
•History of liver cirrhosis.
•History of coronary artery disease.
•Uncontrolled diabetes mellitus.
•Any history of cancer.
+16 more criteria

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

February 3, 2023

Primary Completion Date

September 1, 2027

Completion Date

February 1, 2029

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Univentricular HeartCongenital Heart DiseaseHeart Failure NYHA Class IIIHeart Failure NYHA Class IV

Interventions

iPSC-CL

BIOLOGICAL

Contacts

Adam Armstrong

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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