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New treatment option for Univentricular Heart
Official title Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
ClinicalTrials.gov ID: NCT05647213
What this study is testing
What is iPSC-CL?
iPSC-CL is an investigational medicine, being studied as a potential treatment for univentricular heart.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Individuals may be considered eligible for enrollment for Part I of this study (Skin Punch Biopsy) if in the best judgment of the Principal...
You likely can't join if
- apply to both the treatment and control arms of the study unless otherwise specified. Inclusion Criteria Individuals who meet all the following...
- 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...
- Prognosis of 1 to 1.5 years survival at time of skin biopsy.
See the full eligibility criteria
- Individuals may be considered eligible for enrollment for Part I of this study (Skin Punch Biopsy) if in the best judgment of the Principal Investigator they will meet eligibility criteria outlined below at the time it...
- apply to both the treatment and control arms of the study unless otherwise specified. 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.
- All guideline directed therapy available to the subject has been maximized, for a minimum of 3 months prior to enrollment.
- Adequate social support system that facilitates subject participation in all study required tests and procedures and supports the subject's ability to comply with long-term study requirements. 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.
- Contraindication for use of amiodarone for up to 3 months (treatment arm only).
- Contraindication for insertion of Insertable Cardiac Monitor.
- Contraindication for placement of LifeVest cardioverter defibrillator.
- Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.
- Obesity with BMI greater than 30.
- Current alcohol or drug abuse precluding heart transplantation.
- Active infection requiring ongoing treatment.
- Contraindication to anesthesia.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- History of non-compliance.
- Inability to be accompanied around the clock for any part of the first 3 weeks post product administration.
- Uncontrolled depression.
- Denied heart transplant due to social determinants.
- Current participation in another cardiac treatment clinical trial that could confound the results of this study.
- Previous heart transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.