Establishing a supply system for dental pulp stem cell materials through clinical research involving the provision of deciduous teeth with The University of Tokyo Hospital
First written in FY2021-Q2. 3 of 8 entries say "Restated". Latest entry: FY2023-Q3.
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- FY2023-Q3Cited as achievedAnnual report
「The SHED master cell bank (MCB), which had been developed as the basis for commercializing SHED as a regenerative medicine product, was completed in August 2022. This enabled the Company to establish the integrated system (S-Quatre®) extending from collaboration with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital to obtain primary teeth as the source material for SHED manufacturing, through cell culture and GMP manufacturing of the MCB at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
The Company is reiterating the completed establishment of the integrated S-Quatre system, from SHED source-material supply through GMP manufacturing of the MCB, and the completion of the MCB in August 2022 as achievements already attained. - FY2023-Q2AdvancedAnnual report
「In addition, as an important step toward advancing its regenerative medicine business, the SHED master cell bank (MCB), which had been developed as the basis for commercializing SHED as a regenerative medicine product, was completed in August 2022. This enabled the Company to establish the integrated system (S-Quatre®) extending from collaboration with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital to obtain primary teeth as the source material for SHED manufacturing, through cell culture and GMP manufacturing of the MCB at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
The Company established the integrated system, from primary-teeth source-material supply through GMP manufacturing of the MCB, as S-Quatre, making concrete progress in preparing the foundation for commercializing SHED. - FY2023-Q1RestatedAnnual report
「In addition, as an important step toward advancing its regenerative medicine business, the Company is advancing development of the master cell bank (MCB), which will form the basis for commercializing SHED as a regenerative medicine product, while collaborating with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital to establish a system for obtaining primary teeth as the source material for SHED manufacturing」
The Company has reaffirmed its efforts to establish, through collaboration with ChiVo Net, the University of Tokyo Hospital and Showa University Dental Hospital, a supply system for the primary teeth required to manufacture SHED. - FY2022-Q3RestatedAnnual report
「To establish a system for obtaining primary teeth as the source material for SHED manufacturing, we have advanced collaboration with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital.」
The Company has reaffirmed its policy of establishing, through collaboration with ChiVo Net, the University of Tokyo Hospital and Showa University Dental Hospital, a supply system for the primary teeth required to manufacture SHED. - FY2022-Q2AdvancedAnnual report
「As the necessary preparations have now been completed, we have commenced manufacture of the master cell bank at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd. This will accelerate our research and development activities for regenerative medicine products and strengthen our research and development pipeline through collaboration with academia and companies.」
After advancing preparations for systems to obtain primary teeth in collaboration with ChiVo Net, the University of Tokyo Hospital and Showa University Dental Hospital, the Company commenced MCB manufacturing. Concrete progress is being made toward establishing a system covering source-material procurement through manufacturing. - FY2022-Q1AdvancedAnnual report
「In addition, as part of its future growth strategy, the Company is stepping up development of the enhanced cell therapy “Designer Cells” to achieve higher therapeutic goals. As an important step toward advancing its regenerative medicine business, it is proceeding with the manufacture of the master cell bank (MCB) and other materials that will form the basis for commercializing SHED as a regenerative medicine product, in collaboration with Nikon Cell Innovation Co., Ltd. At the same time, it is developing systems in collaboration with the University of Tokyo Hospital and Showa University Dental Hospital to obtain primary teeth as the source material for SHED manufacturing. Going forward, while continuing activities through the “ChiVo Net Future Medicine Children’s Volunteer Network,” announced in June 2021, the Company aims to establish a stable and integrated system covering the procurement of source materials through SHED manufacturing.」
In addition to the system for obtaining primary teeth from the University of Tokyo Hospital and Showa University Dental Hospital, the Company is expanding its efforts to establish a stable and integrated system covering SHED source-material procurement through manufacturing by advancing activities through ChiVo Net. - FY2021-Q3RestatedAnnual report
「Meanwhile, the company began a clinical study in collaboration with The University of Tokyo Hospital to obtain donated deciduous teeth as raw materials for manufacturing dental pulp stem cells. By establishing the clinical study, it aims to establish a stable system for obtaining deciduous teeth and build a stable dental pulp stem cell manufacturing system using the MCB described above.」
The company reconfirmed its policy of building a stable supply of deciduous teeth and a stable dental pulp stem cell manufacturing system using the MCB, based on the clinical study involving donated deciduous teeth conducted in collaboration with The University of Tokyo Hospital. - FY2021-Q2First statedAnnual report
「In connection with this project, the company began in August 2020 a clinical study in collaboration with The University of Tokyo Hospital to obtain donated deciduous teeth as raw materials for manufacturing dental pulp stem cells. This is Japan's first initiative to obtain deciduous teeth as raw materials for manufacturing dental pulp stem cells based on the "Guidance on the Supply of Human (Allogeneic) Cell Raw Materials (First Edition)." By establishing this clinical study, the company aims to establish a stable system for obtaining deciduous teeth and to build a stable dental pulp stem cell manufacturing system using the MCB described above.」
In collaboration with The University of Tokyo Hospital, the company began a clinical study to obtain donated deciduous teeth as raw materials for manufacturing dental pulp stem cells. Through establishing the clinical study, it aims to secure a stable supply of deciduous teeth and build a stable dental pulp stem cell manufacturing system using the MCB.