Who We Are
Who We Are
We build, test, and deliver new therapies to cure congenital heart defects, allowing families to live full, enriching lives.
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Our Work
Our Work
HeartWorks builds, tests, and delivers new therapies to cure congenital heart defects giving these families the opportunity to live full, enriching lives.
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HeartWorks relies on our community to help fund the research and clinical trials that hope to find cures for congenital heart defects (CHD). Discover ways that you can help.
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Clinical Trials
Clinical Trials
Learn about upcoming, ongoing, and previous CHD clinical trials being done with our consortium partners.
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The Co-op
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Provider Information

THE WAY WE WORK TOGETHER WORKS WONDERS.
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Patient Information

The Co-op @ HeartWorks is a medical record and research database comprised of EMR data donated by individuals with CHD.

Our goal is to transform clinical innovation and execution of clinical trials to accelerate product development for the CHD Community.

  • It is free to use
  • Access data from CHD patients nationwide
  • All we need is your referral
HeartWorks Logo with We Build Hearts tagline and heart icon

About Us

HeartWorks is a 501(c)(3) organization established in June 2020 to further the product development initiated by the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS), which was founded at the Mayo Clinic in 2010.

Our vision is to transform our therapies into a cure, so that children and adults born with congenital heart disease (CHD) no longer have to live with its challenges.

Our Products

Bioengineered Cardiac Tissue produces contracting heart muscle cells that are genetically identical to the patient’s own body; a “seed” that can be planted in a failing heart to help rebuild the weak muscle.

In order to generate those genetically identical cardiac muscle cells, patient skin cells (fibroblasts) are obtained by a simple skin cell biopsy. This procedure involves a minimally invasive skin punch to obtain a small number of skin cells which are then treated in the laboratory to multiply the number of cells and convert them to heart muscle cells (cardiomyocytes) for delivery to patient heart muscle.

The Co-op @ HeartWorks is a database for individuals with CHD. The goal of the co-op is to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members.

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Provider Benefits

Accelerate Research

Referring your patients will streamline recruitment for clinical trials.

Host Clinical Trials

Concentrated patients in your geographical location may enable innovative research at your institute.

Become a Principle Investigator

High volume of patient referrals will position you to become a funded principle investigator for a new trial

Give Your Patients Hope

Patients registered to the Co-Op will be notified if they qualify for a clinical trial and are encouraged to participate

How The Co-op Works

  1.  Refer your patient to The Co-op
  2.  Your patient registers as a member of The Co-op
  3.  Patient EMRs are linked
  4.  Access the Data

Currently Enrolling Clinical Trials

HeartWorks alongside our partners are always developing new trials. Browse current available trials for CHD.

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  • HeartWorks

    The Co-op at HeartWorks

    This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-op @ HeartWorks members.
    // ONGOING
  • HeartWorks

    Skin Punch Biopsy Collection

    Generate autologous iPSC in a manner compliant with requirements for future autologous clinical use. This may reduce manufacturing time when patients are identified as eligible to receive autologous product under a separate interventional treatment protocol. Clinical Site: Mayo Clinic.
    // ONGOING
  • HeartWorks

    Bioengineered Cardiac Tissue Phase I First in Human

    The purpose of this study to test the feasibility and safety for autologous (from your own body) skin cells that are manufactured into stem cells of cardiac lineage to be delivered into the heart muscle to determine if those stem cells will strengthen the heart muscle and can be used as an additional treatment for the management of congenital heart disease. Clinical Site: Mayo Clinic.
    20231201 // ONGOING

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