Actively Recruiting
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
Led by HeartWorks, Inc. · Updated on 2026-03-13
50
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 40 years old
- Ability to understand and provide informed consent
- Diagnosis of univentricular congenital heart disease
- End-stage systolic heart failure, NYHA Class IV with ejection fraction below 40%
- Prognosis of 1 to 1.5 years survival at time of skin biopsy
- Currently listed for heart transplantation with expected waiting time longer than life expectancy, or denied access to transplantation, or on/planning mechanical support as destination therapy
- Maximized guideline-directed therapy for at least 3 months prior to enrollment
- Adequate social support system to comply with study requirements
You will not qualify if you...
- No available autologous iPSC-CL product (treatment arm only)
- History of symptomatic cardiac arrhythmia requiring defibrillation or medication escalation
- Heart failure with preserved ejection fraction
- Heart failure caused by other conditions like amyloidosis, valvular disease, or refractory anemia
- QTc interval 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
- Contraindication to amiodarone use for 3 months (treatment arm only)
- Contraindication to insertion of Insertable Cardiac Monitor
- Contraindication to placement of LifeVest cardioverter defibrillator
- Positive serology for HIV, Hepatitis B, Hepatitis C, or Syphilis
- Obesity with BMI over 30
- Current alcohol or drug abuse preventing heart transplantation
- Active infection requiring treatment
- Contraindication to anesthesia
- Other medical problems posing risks or interfering with study participation
- Inability or unwillingness to give informed consent or comply with protocol
- History of non-compliance
- Inability to be accompanied around the clock for the first 3 weeks after product administration
- Uncontrolled depression
- Denied heart transplant due to social reasons
- Current participation in another cardiac interventional clinical trial
- Previous heart transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
Research Team
A
Adam Armstrong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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