Addition of an indication for dilated cardiomyopathy
First written in FY2023. 3 of 7 entries say "Advanced", first in FY2024-Q1. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026DroppedAnnual report
「The above represents the research and development pipeline held by the company.」
The research and development pipeline list and the body of this filing no longer include the previously described cardiomyocyte sheet for DCM. No explicit reason for the withdrawal is given. - 2026-06-03RestatedGeneral Meetings of Shareholders
「ヒトiPS細胞由来細胞をカテーテルによる新たなアプローチで心臓へ移植する治療技術や、体内再生因子誘導による治療薬のみならず、新規開発パイプラインの拡充を図るべく、ヒトiPS細胞由来心筋細胞シートに続くパイプラインの試作品の開発や治験準備等、製品化に向けた取り組みを推進してまいります。」
既存の主要パイプライン及び新規パイプラインの製品化に向けた取り組みを継続している。 - FY2025-H1AdvancedAnnual report
「During the interim consolidated accounting period under review, Osaka University began an investigator-initiated clinical trial for DCM, and transplantation was performed in 2 subjects. We produced and provided Osaka University with the human iPS cell-derived cardiomyocyte sheets to be transplanted into the subjects.」
The investigator-initiated clinical trial for the DCM indication began, with transplantation performed in 2 subjects. The company produced and supplied the cell sheets for transplantation. - FY2024RestatedAnnual report
「During the consolidated fiscal year under review, we proceeded with subject recruitment while carefully assessing the impact of infectious diseases such as influenza and COVID-19. As a participating institution, we were subcontracted by Osaka University to conduct part of the research and development and supported the clinical trial being advanced by the university.」
Subject recruitment and support for Osaka University’s clinical trial continued toward adding the DCM indication. - FY2024-Q3AdvancedAnnual report
「During the cumulative third-quarter period under review, we proceeded with subject recruitment toward the planned start of the investigator-initiated clinical trial in January–March 2024, while carefully assessing the impact of infectious diseases such as influenza and COVID-19. As a participating institution, we were also subcontracted by Osaka University to conduct part of the research and development and supported the clinical trial being advanced by the university.」
The company entered the subject-recruitment stage in preparation for starting the investigator-initiated clinical trial between January and March 2024. - FY2024-Q1AdvancedAnnual report
「Research and development on dilated cardiomyopathy (DCM) was selected for the FY2023 “Research Program for the Practical Application of Regenerative Medicine” of the Japan Agency for Medical Research and Development (AMED). As a participating institution, we have been subcontracted by Osaka University to conduct part of the research and development and are supporting the protocol design and other aspects of the clinical trial being advanced by Osaka University.」
The DCM indication-expansion research was selected for an AMED FY2023 program, and the company is supporting clinical-trial protocol design as a participating institution. - FY2023First statedAnnual report
「To expand the target population for the human iPS cell-derived cardiomyocyte sheet, we plan to conduct research and development to add dilated cardiomyopathy as an indication.」
Based on efficacy in a DCM animal model, the company planned to support Osaka University’s protocol design for an investigator-initiated clinical trial and add the indication to PJ1.