Advancing clinical development of the LAPiS trial
First written in FY2024. 5 of 8 entries say "Advanced", first in FY2026-H1. Latest entry: 2026-08-31.
0 other companies' latest entry also says "Cited as achieved".
- 2026-08-31Cited as achievedOther Disclosures
「In addition to safety at 26 weeks after transplantation, the primary endpoint, we evaluated safety and efficacy at 52 weeks after transplantation as secondary endpoints.」
The Company announced the 52-week safety and efficacy evaluation results of the LAPiS study as top-line results. - FY2027-H1AdvancedAnnual report
「In the domestic Phase I/II clinical trial conducted in combination with coronary artery bypass surgery, the LAPiS trial, analysis of all 10 cases, including data compilation and interpretation by a third-party organization, has been completed. The results showed no safety concerns, the primary endpoint, that would affect our policy toward filing an application for marketing approval. In terms of efficacy, the secondary endpoint, favorable results were obtained across multiple measures relating to cardiac pump function and the reduction in the size of the enlarged heart, supporting our policy of filing an approval application.」
For the LAPiS trial, analysis of the planned 10 cases, including data compilation and interpretation by a third-party organization, has been completed, yielding safety and efficacy results. - FY2025AdvancedAnnual report
「Administration and enrollment have already been completed for all 10 patients, and the 52-week follow-up specified in the clinical trial was completed in January 2026.」
The LAPiS trial completed administration for all 10 patients, and the specified 52-week follow-up was also completed for all 10 patients in January 2026. - FY2026-H1AdvancedAnnual report
「In the ongoing Phase I/II clinical trial conducted in combination with coronary artery bypass surgery, the LAPiS trial, enrollment of the planned 10 patients, consisting of 5 in the low-dose group and 5 in the high-dose group, was completed with administration to the final patient during the first quarter accounting period.」
Administration to the final patient in the planned 10-patient LAPiS trial was completed. The statement does not indicate that the trial as a whole or the approval process has been completed. - FY2024First statedAnnual report
「The trial is planned to enroll a total of 10 patients, comprising 5 low-dose patients (50 million cells, single administration) and 5 high-dose patients (150 million cells, single administration). As of the end of October 2024, administration had been completed for 8 patients, 4 of whom had completed 52 weeks of follow-up.」
The trial planned for 5 low-dose and 5 high-dose patients, for a total of 10; administration was completed for 8 patients, and 4 had completed 52 weeks of follow-up.