HS-001 / Heartseed, Novo Nordisk - LARVOL DELTA

A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) (clinicaltrials.gov) - P1/2 | N=10 | Active, not recruiting | Sponsor: Heartseed Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2025 ➔ Jul 2025

Enrollment closed • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

First-in-human study of left ventricular remuscularization with induced pluripotent stem cell derived cardiomyocyte spheroids for severe ischemic heart failure patients: preliminary LAPiS study result (HEART FAILURE 2024) - "The LAPiS study is a first-in-human, phase I/II clinical trial of allogeneic iPSCs-derived cardiomyocyte spheroids (HS-001), for the treatment of patients with sHF... The LAPiS study introduces the first and only iPSC-derived cardiomyocyte spheroid therapy for sHF. The early results demonstrate the potential to deliver functional improvement in patients with advanced heart failure where improvements due to CABG alone are limited. The managed risks of immunosuppression and graft-related arrhythmia pave the way for this direct myocardial therapy to become a practical and effective approach."

Clinical • P1 data • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Heartseed Inc. | Trial completion date: Mar 2024 ➔ Jan 2026 | Trial primary completion date: Sep 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

Heartseed Announces the Presentation of HS-001, an Investigational Stem Cell-Derived Therapy for the Treatment of Advanced Heart Failure at the 71st Annual Meeting of the Japanese College of Cardiology (Businesswire) - "Heartseed...today announced that the case reports of two patients in the Phase 1/2 clinical trial (LAPiS Study) of HS-001 in combination with coronary artery bypass grafting surgery for advanced heart failure, was presented by the investigator at the 71st Annual Meeting of the Japanese College of Cardiology (JCC) on September 9, 2023."

Trial status • Cardiovascular • Heart Failure

A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Heartseed Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • NPPB

A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: Heartseed Inc. | Initiation date: Aug 2021 ➔ Apr 2022

Trial initiation date • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • NPPB

Heartseed, "Novo's due diligence was a total war" [Google translation] (Nikkei) - "Heartseed also submitted a clinical trial report for HS-001 to the Pharmaceuticals and Medical Devices Agency (PMDA), and the investigation was completed in March 2021. In the latter half of 2021, it plans to start a domestic phase 1/2 clinical trial (LAPiS trial) for severe heart failure due to ischemic heart disease as a corporate clinical trial....Heartseed has granted Novo the exclusive right to develop, manufacture and sell allogeneic iPS cell-derived myocardial spheres (HS-001, the same as allogeneic iPS cell-derived regenerated myocardium) worldwide except Japan....Based on the contract, Heartseed will receive $ 55 million....In the series C round on June 11, 2021, a total of 4 billion yen was raised from the University of Tokyo collaborative creation platform development (Tokyo University IPC), SBI Group and others. The funds raised this time will be used to promote the domestic phase 1/2 clinical trial (LAPiS trial) of HS-001 to be conducted as a corporate clinical trial..."

Financing • Licensing / partnership • Trial initiation date • Cardiovascular • Heart Failure

A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) (clinicaltrials.gov) - P1/2; N=10; Not yet recruiting; Sponsor: Heartseed Inc.

Clinical • New P1/2 trial • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • MRI