Heartseed announces first patient dosed 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 10, 2023

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. (CEO: Keiichi Fukuda, head office: Tokyo, hereinafter "Heartseed").

Heartseed today announced that it has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with 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 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 in 2015 to develop and commercialize cardiac remuscularization therapy developed by Professor Keiichi Fukuda and his group at the Department of Cardiology, Keio University, Tokyo, Japan. Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte-cell product, including purification, cell delivery and iPSC production. Heartseed received “Minister of Science and Technology Policy Award” at Japan Venture Awards 2021, “Ministry of Education, Culture, Sports, Science and Technology Award” at Academic Startups 2021, and “Most Promising Pipelines Awards (iPSC)” at Asia Pacific Cell & Gene Therapy Excellence Awards 2022.

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 remuscularisation, as well as secretion of angiogenic factors to form new blood vessels around the transplant site (neovascularisation).

For more information, please visit Heartseed's website.