Heartseed announces enrollment completion in a phase 1/2 LAPiS Study with HS-001 – a cell therapy designed to restore heart function in people with advanced heart failure
HS-001 is manufactured by Nikon CeLL innovation

February 3, 2025

TOKYO - Nikon CeLL innovation Co., Ltd. (Nikon CeLL innovation), a subsidiary of Nikon Corporation (Nikon), manufactures iPSC derived purified heart muscle cells and their clusters (HS-001), under contract to Heartseed Inc. (Heartseed).

Heartseed today announced the completion of 10th and final patient enrollment in a phase 1/2 clinical study (LAPiS Study) for HS-001 – an investigational iPSC-based therapy for heart failure.
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.

HS-001 has been manufactured by Nikon CeLL innovation under contract to Heartseed. Nikon CeLL innovation and Heartseed will continue to collaborate for future stable supply of this treatment in the commercial phase of Japanese market by leveraging the know-how and technology of both companies.

Nikon and Nikon CeLL Innovation will contribute to this effort towards the practical use of regenerative medicine in Japan and to the improvement of QOL (Quality of Life).

About Heartseed

Heartseed Inc. was founded with the aim of realizing cardiac remuscularization therapy, and it was listed on the Tokyo Stock Exchange Growth Market in July 2024 (Stock Code: 219A). Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte-cell product, including purification, cell delivery and iPSC production.
Heartseed announced the global collaboration and license agreement with Novo Nordisk A/S for HS-001 in June 2021.

About HS-001

HS-001 consists of allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroids. By forming micro-tissue-like spheroids, the retention rate and viability of the cell transplant have been improved in preclinical studies compared to single cell suspensions. The spheroids are transplanted using a special administration needle and guide adapter developed for the administration of the spheroids into the myocardial layer of the heart.
The expected mechanism of action is coupling of the transplanted cardiomyocytes to the patient's myocardium, thereby improving cardiac output by remuscularization, as well as secretion of angiogenic factors to form new blood vessels around the transplant site (neovascularization).

For more information, please visit Heartseed’s website.