Who We Are
We build, test, and deliver new therapies to cure congenital heart defects, allowing families to live full, enriching lives.
Learn More
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 – Something here about a collective effort to provide more options to tranform outcomes of CHD. non-threatening/we need all hands on deck/can’t do it without you feeling.
Summary of products discussed below.
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
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.
link / email /etc
This study focuses on collecting a small skin biopsy sample to generate autologous induced pluripotent stem cells (iPSCs). These cells are created in a way that meets clinical standards, ensuring they are ready for future therapeutic use.
By completing the iPSC manufacturing process in advance, this study helps reduce the time needed to prepare patient-specific stem cells when they are required for treatment. This is particularly important for patients who may later qualify for stem cell therapy to strengthen the heart muscle.
At HeartWorks, critical advances in medicine start with foundational research, paving the way for innovative and effective therapies. Our Research and Development (R&D) team is at the forefront of this journey, driving our efforts to enhance and refine our bioengineered cell therapies.
A central focus of our R&D team is the in-depth characterization of cells used in our cardiomyocyte-based therapies. We begin with patient skin cells, which are converted into induced pluripotent stem cells (iPSCs). These iPSCs are then selectively differentiated into functional cardiomyocytes, or heart muscle cells. This process is intricate and involves creating bioengineered cell products that include various sub-types of cardiomyocytes.
Our R&D team has developed advanced methods to analyze these cell sub-types, gaining insights into their molecular characteristics and clinical potential. In 2023, we introduced two key approaches to advance this work:
The ultimate goal of our genetic and electrical studies is to develop patient-specific cardiomyocyte preparations that optimize heart muscle function and enhance therapeutic outcomes. Through these advancements, HeartWorks is committed to pushing the boundaries of medical research and delivering cutting-edge solutions to improve patient care.
HeartWorks innovative bioengineered cell therapies rely heavily on our exceptional manufacturing team. This team is essential in executing the intricate, multi-step processes required to transform patient skin cells into induced pluripotent stem cells (iPSCs), expand these stem cells, and then differentiate them into functional cardiomyocytes (heart muscle cells) for our therapies.
Our manufacturing processes have evolved continuously, with the development of robust, FDA-approved procedures crucial for our clinical trials. The achievements of our manufacturing team in 2023 reflect substantial progress, as demonstrated by the dramatic increase in cardiomyocyte yield:
2015 | 2017 | 2019 | 2023 | future |
100K | 4M | 300M | 3B | ++ |
This impressive scaling of production capacity highlights the innovation, productivity, and quality of our manufacturing operations. In 2023, our team enhanced batch sizes by increasing the number of vessels used for each sample, proving to be more effective than altering vessel sizes or designs. Additionally, we optimized productivity through refined synchronization of manufacturing activities.
Looking ahead, as patient numbers and clinical trials increase, we plan to incorporate bioreactors. These advanced systems will provide optimized conditions for producing cardiomyocytes, further advancing our ability to meet growing demand and continue delivering groundbreaking therapies.
Our manufacturing team’s dedication is a cornerstone of HeartWorks’ success, enabling us to push the boundaries of medical research and provide cutting-edge treatments to patients.
Our Co-op program addresses key challenges in managing patient records by providing a centralized, patient-controlled database. This system securely aggregates medical records from all providers, if the patients choose, making it easier for CHD patients and their families to access and manage their health information for their care and for use by HeartWorks and potentially other researchers.
The Co-op will be a major contributor to the heart community and to HeartWorks transforming patient care for CHD patients and their families.
Become a member of The Co-op here.
This study is evaluating the feasibility and safety of using stem cells derived from a patient’s own skin to help strengthen the heart muscle. These cells, generated in the Skin Punch Biopsy Sample Collection study, are transformed into cardiac lineage cells and delivered into the heart muscle.
By using a patient’s own stem cells, this study aims to explore whether personalized regenerative medicine can be a viable treatment option for congenital heart disease. Thanks to the preparation done in the biopsy study, patients may be able to receive this treatment more quickly
At HeartWorks, critical advances in medicine start with foundational research, paving the way for innovative and effective therapies. Our Research and Development (R&D) team is at the forefront of this journey, driving our efforts to enhance and refine our bioengineered cell therapies.
A central focus of our R&D team is the in-depth characterization of cells used in our cardiomyocyte-based therapies. We begin with patient skin cells, which are converted into induced pluripotent stem cells (iPSCs). These iPSCs are then selectively differentiated into functional cardiomyocytes, or heart muscle cells. This process is intricate and involves creating bioengineered cell products that include various sub-types of cardiomyocytes.
Our R&D team has developed advanced methods to analyze these cell sub-types, gaining insights into their molecular characteristics and clinical potential. In 2023, we introduced two key approaches to advance this work:
The ultimate goal of our genetic and electrical studies is to develop patient-specific cardiomyocyte preparations that optimize heart muscle function and enhance therapeutic outcomes. Through these advancements, HeartWorks is committed to pushing the boundaries of medical research and delivering cutting-edge solutions to improve patient care.
HeartWorks innovative bioengineered cell therapies rely heavily on our exceptional manufacturing team. This team is essential in executing the intricate, multi-step processes required to transform patient skin cells into induced pluripotent stem cells (iPSCs), expand these stem cells, and then differentiate them into functional cardiomyocytes (heart muscle cells) for our therapies.
Our manufacturing processes have evolved continuously, with the development of robust, FDA-approved procedures crucial for our clinical trials. The achievements of our manufacturing team in 2023 reflect substantial progress, as demonstrated by the dramatic increase in cardiomyocyte yield:
2015 | 2017 | 2019 | 2023 | future |
100K | 4M | 300M | 3B | ++ |
This impressive scaling of production capacity highlights the innovation, productivity, and quality of our manufacturing operations. In 2023, our team enhanced batch sizes by increasing the number of vessels used for each sample, proving to be more effective than altering vessel sizes or designs. Additionally, we optimized productivity through refined synchronization of manufacturing activities.
Looking ahead, as patient numbers and clinical trials increase, we plan to incorporate bioreactors. These advanced systems will provide optimized conditions for producing cardiomyocytes, further advancing our ability to meet growing demand and continue delivering groundbreaking therapies.
Our manufacturing team’s dedication is a cornerstone of HeartWorks’ success, enabling us to push the boundaries of medical research and provide cutting-edge treatments to patients.
Our Co-op program addresses key challenges in managing patient records by providing a centralized, patient-controlled database. This system securely aggregates medical records from all providers, if the patients choose, making it easier for CHD patients and their families to access and manage their health information for their care and for use by HeartWorks and potentially other researchers.
The Co-op will be a major contributor to the heart community and to HeartWorks transforming patient care for CHD patients and their families.
Become a member of The Co-op here.
