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Heartseed and Novo Nordisk announce first patient dosed in clinical study

Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure.

An independent safety evaluation committee has evaluated 4-week data on the patient, who lives with advanced heart failure and has given approval for the study to continue.

An investigational cell therapy

HS-001 is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from induced pluripotent stem cells (iPSCs) that are designed to restore heart muscle and function in patients with advanced heart failure. In several preclinical studies iPSC-derived cardiomyocytes have been shown to improve heart function.


“Cell therapy holds the promise to offer truly disease-modifying treatments for people living with serious chronic disease. We are very pleased that our partners from Heartseed have begun clinical testing of this innovative approach to treating heart failure,” said Jacob Sten Petersen, corporate vice president of Cell Therapy R&D in Novo Nordisk. “We aim to build on Heartseed’s pioneering work in Japan and hope to bring a transformative treatment to people living with heart failure across the globe.”

The LAPiS Study

The LAPiS Study is a 52-week, phase 1/2, open-label, dose-escalation study in patients with advanced heart failure caused by ischaemic heart disease, conducted at various study sites in Japan. HS-001 will be transplanted into the diseased tissue of the heart during open-heart surgery in conjunction with a planned coronary artery bypass graft procedure. The study will enrol 10 patients in two dose cohorts of 50 million and 150 million cardiomyocytes.

The primary endpoint of the study is safety at 26 weeks post-transplantation, and secondary efficacy endpoints include left ventricular ejection fraction and myocardial wall motion.

Photo: Novo Nordisk headquarter