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SCM-101 is an allogeneic, off-the-shelf cell therapy composed of induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Developed by StemCardia (formerly Heart Stem), the therapy is designed to treat heart failure following a myocardial infarction by regenerating damaged cardiac tissue. SCM-101 is administered via direct intramyocardial injection into the infarct zone, where the cells are intended to engraft and integrate with the host myocardium to restore both contractile and electrical function. Preclinical research, including studies in non-human primates, has shown that these cells can achieve electrical integration and help manage engraftment-related arrhythmias. The production of clinical-grade iPSC Master and Working Cell Banks for SCM-101 is supported by the Cedars-Sinai Biomanufacturing Center.
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