Heartseed Doses First Patient in Historic iPSC-Derived Cardiomyocyte Trial Via Catheter

Key Points

• Heartseed has dosed the first patient in its Phase I/II EMERALD study of HS-005 for severe heart failure.
• The study is the first trial to deliver induced pluripotent stem cell (iPSC)-derived cardiomyocyte spheroids by catheter.
• The trial plans to enroll 14 patients with heart failure caused by ischemic heart disease or dilated cardiomyopathy.

Heartseed, a Japanese company pioneering iPSC-derived regenerative medicine, has dosed the first patient in its Phase I/II EMERALD study of HS-005, an allogeneic (donor derived) induced pluripotent stem cell (iPSC)-derived cardiomyocyte spheroid therapy for severe heart failure.

The therapy is delivered by catheter in patients with heart failure caused by ischemic heart disease or dilated cardiomyopathy, the world’s first clinical study using this technique with iPSC-derived cardiomyocyte spheroids.

The first patient, who had dilated cardiomyopathy, was treated at Shinshu University Hospital in late March 2026. According to the company, the postoperative course was generally uneventful, and the patient was discharged.

HS-005 and Trial Design

The company’s lead program, HS-001, requires open-heart surgery, while HS-005 does not, making it potentially significantly less invasive. The cardiomyoctes are expected to engraft into the myocardium, improve cardiac contractility through remuscularization, and promote neovascularization.

The trial plans to enroll:

• 7 patients in the ischemic heart disease cohort
• 7 patients in the dilated cardiomyopathy cohort
• 14 patients in total

To evaluate the safety and efficacy of the program.

More information is available on Heartseed’s website.

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