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Allogeneic induced pluripotent stem cell-derived cardiomyocyte cardiac spheres (hiPSC-CSs) are an investigational advanced therapy medicinal product (ATMP) consisting of three-dimensional spheroid aggregates of cardiomyocytes. These cardiomyocytes are differentiated from allogeneic (donor-derived) human induced pluripotent stem cells (hiPSCs). The therapy is designed to treat severe heart failure, specifically dilated cardiomyopathy (DCM) and heart failure with reduced ejection fraction (HFrEF), by regenerating lost or dysfunctional myocardium. The spheroid structure is utilized to enhance the survival and engraftment of the cells upon direct intramyocardial injection into the heart muscle layer. The primary therapeutic goal is to restore cardiac contractile function and improve overall heart performance in patients with advanced heart disease through the integration of functional cardiomyocytes into the host tissue.
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