Heartseed Inc. announced that it had completed administration to the first patient in the domestic Phase I/II EMERALD study of HS-005, a treatment involving catheter delivery of allogeneic iPS cell-derived cardiac spheroids. This increases the possibility that it could become the world's first cardiac cell therapy delivered by catheter.
On 12 June 2026, Heartseed Inc. announced that it had successfully administered allogeneic iPS cell-derived cardiac spheroids by catheter to the first patient in a clinical trial targeting left ventricular dysfunction caused by dilated cardiomyopathy or ischemic heart disease. The administration was performed in the domestic EMERALD study (domestic Phase I/II), and the procedure reportedly was completed in a short time without complications.
The trial plans to enroll 14 patients and is an open-label, multicenter study administering 150 million cardiomyocytes per patient. The primary endpoint is safety at 26 weeks after administration, with safety and efficacy at 52 weeks set as secondary endpoints. The first patient was administered treatment at Shinshu University Hospital and has since been discharged, and the Independent Safety Evaluation Committee has approved continuation.
Unlike administration through open-chest surgery, HS-005 uses a minimally invasive approach that delivers treatment from inside the heart with a dedicated catheter system. The administered cardiac spheroids are expected to connect with surrounding myocardium, promote remuscularization, and induce local angiogenesis. Heartseed Inc.'s president referred to the minimally invasive nature of the procedure and said that the successful administration after adding dilated cardiomyopathy to the target diseases would help provide treatment for patients with severe heart failure.