Heartseed, World's First Clinical Trial of Catheter Administration of iPSC-Derived Cardiomyocyte Spheroids: First Patient Dosed
Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company, today announced the successful dosing of the first patient in its domestic Phase I/II EMERALD study of HS-005, allogeneic iPS cell-derived cardiomyocyte spheroids administered via catheter, targeting severe heart failure caused by ischemic heart disease or dilated cardiomyopathy.
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This study marks the world's first clinical trial to administer iPS cell-derived cardiomyocyte spheroids using a catheter. The administration to the first patient suffering from dilated cardiomyopathy was successfully completed at Shinshu University Hospital in late March 2026. The patient's postoperative course has been generally uneventful, and the patient has already been discharged. Furthermore, the independent Safety Monitoring Committee evaluated the 4-week data and approved the study to continue in dilated cardiomyopathy cohort.
"Catheter administration enables the minimally invasive delivery of cardiomyocytes", said Keiichi Fukuda, CEO of Heartseed. "The inclusion of patients with dilated cardiomyopathy as a new target is a highly significant milestone in our goal to save more patients with severe heart failure.”
