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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHeartWorks, Inc.

About this trial

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 criteria

Qualifiers

None

Disqualifiers

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%.

Trial design

Treatments tested in this trial

  • iPSC-CL

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators