Skin Biopsy Collection for Future Congenital Heart Disease Treatment

This study is collecting skin samples from people with congenital heart disease (CHD) to prepare for a future treatment. The goal is to create special cells called induced pluripotent stem cells from your skin, which could then be used in a separate treatment study. By collecting these samples now, the researchers hope to reduce the time it takes to prepare these cells when you might be eligible for that future treatment. You can join if you are 18 or older, have congenital heart disease, and are likely to qualify for a specific future clinical trial (IND 28611). You cannot join if you've had a heart transplant, have HIV or Hepatitis, or are unable to consent. The study will measure if they can successfully make these stem cells within 12 months.

Study design
This is an observational study, meaning it involves collecting information and samples without giving a specific treatment. It plans to enroll about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of successfully manufacturing stem cells is measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06588426

Clinical Readiness Skin Punch Biopsy Sample Collections

Recruiting
Not specifiedAges 18+Observational
HeartWorks, Inc.
~100 participants
Updated 2025-06-25 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful manufacture of induced pluripotent stem cells
Measured over 12 months
Congenital Heart Disease (CHD)
Congenital Heart Defect

NCT06588426

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

Age 18 and older
Congenital heart disease
Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion

Previous cardiac transplantation
Unable or unwilling to consent
HIV diagnosis
Hepatitis diagnosis
  • Successful manufacture of induced pluripotent stem cells12 months

    Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.