HeartWorks builds, tests, and delivers new therapies to cure congenital heart defects giving these families the opportunity to live full, enriching lives. 

We cultivate a product innovation culture, maintaining a pipeline of innovation targeted to improve heart muscle strength and overall heart function to dramatically improve individual outcomes. We partner across an ecosystem of medical experts, institutional collaborators, and activated communities to ensure we are making continuous progress while evaluating bold ideas. 

As a non-profit foundation, we strive to accelerate a new standard of care for everyone with CHD by empowering this community with the convergence of people, processes, and technology needed for disruptive innovation.

Bioengineered Cardiac Tissue

This product 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 re-build the weak muscle. It is potentially effective even in older patients that have lost the ability to regenerate their heart muscle on their own.

This technology has the potential to cost effectively scale, as autologous heart muscle could be manufactured starting from a skin biopsy. Manufactured heart muscle cells could potentially be re-packaged into multiple forms, to optimize heart strength for many types of CHD patients. This product has been the source of much academic speculation for the past decade, given its obvious advantages over any other product. Our commitment to this product line for the past decade has positioned us to lead, with the first clinical trial in the world.

CLINICAL TRIAL DETAILS:

Mayo Clinic Research Study Seeking Single Ventricle Congenital Heart Disease Patients

Mayo Clinic researchers are seeking adults, ages 18 to 40, with single ventricle Congenital Heart Disease (CHD), in end-stage heart failure, to participate in a clinical trial. The purpose of this study is to evaluate an investigational stem cell product.

Study participation involves an initial visit with a skin biopsy and blood draw. The processing time for the skin biopsy is up to 12 months. If processing is successful and the participant meets the study’s criteria, the investigational stem cell product would then be administered into the heart via injections. Lifetime follow-up visits will be performed.

Travel reimbursement is available.

For more information contact hlhs@mayo.edu

CardiaCord

CardiaCord is currently being tested in a multi-center Phase IIb clinical trial, with 73 patients treated to-date. It is an autologous (self) cell-based product and has been shown in pre-clinical settings to stimulate native heart muscle cells to grow faster and bigger. A Phase III study appears likely at this point, based on very encouraging results. These results would not have been possible without the HLHS Consortium and demonstrate the potential of that consortium to deliver breakthrough cardiac stem cell therapy. CardiaCord was developed by a cross-functional team and is an example of how multi-center clinical trials can be used for CHD treatments.

This “fertilizer” approach is most effective when applied as early as possible in the surgical care of infants and children with CHD. Our hope is that this product will be able to preserve heart muscle function during clinical procedures that are required for approximately 25% of CHD patients in the first year of their lives. The infant heart has the most robust capacity to respond to growth stimulation, so applying our solution at this stage has potential to have a lasting impact.