Development of an Implementation Framework and Evaluation Methods for Regenerative Medicine
First written in FY2016. 16 of 28 entries say "Advanced", first in FY2017-Q1. Latest entry: 2026-10-30.
No other company in this theme has enough history to compare yet.
- 2026-10-30AdvancedEarnings
「他家（同種）培養表皮（開発名：Allo-JaCE03）は、熱傷を含む皮膚欠損を適応とし、2026年３月に製造販売承認申請を行っており、2027年３月期中の承認に向け順調に進展しています。」
Allo-JaCE03について、製造販売承認申請後、2027年3月期中の承認に向けた進捗を示している。 - FY2026Postponement of the Allo-JaCE03 marketing-authorization application and launch targetsAnnual report
「The allogeneic cultured epidermis product, under the development name Allo-JaCE03, is indicated for skin defects, including burns, and a marketing authorization application was filed in March 2026. Its proprietary drying technology enables both long-term storage at room temperature and immediate use, allowing rapid delivery. The company aims to provide the product rapidly to emergency-care settings and is also considering expansion into overseas markets.」
Allo-JaCE03 has reached the stage of filing a marketing authorization application. However, the strategic launch target has been set for the fiscal year ending March 2028, delayed from the previous target of the fiscal year ending March 2027. - FY2025SoftenedAnnual report
「Indicated for skin defects, including burns, the product is progressing smoothly toward the filing of a marketing authorization application, with a launch targeted for the fiscal year ending March 2027. We will also accelerate expansion into overseas markets, in addition to Japan, by capitalizing on the product's characteristics as an allogeneic, dry product.」
Allo-JaCE03 has completed clinical trials and moved into preparations for the marketing authorization application. However, the current disclosure sets the launch target at the fiscal year ending March 2027, compared with the previously stated target of the fiscal year ending March 2026. - FY2025-H1AdvancedAnnual report
「Allogeneic cultured epidermis, developed under the name Allo-JaCE03, completed a clinical trial in patients with deep partial-thickness second-degree burns, a representative disease causing skin defects. The epithelialization rate at the Allo-JaCE03 application site on day 7 after the initial application, the primary endpoint, was shown to be statistically significantly higher than the estimated epithelialization rate with existing treatment methods. No clinically concerning adverse events were observed in terms of safety. The company is currently preparing a marketing-authorization application with the aim of launching the product in the fiscal year ending March 2026. It will accelerate expansion into overseas markets as well as Japan by capitalizing on the product's characteristics as an allogeneic and dried product.」
For Allo-JaCE03, the company completed the clinical trial and confirmed that the primary endpoint was statistically significantly better than the estimated value for existing treatments, with no clinically concerning adverse events. It advanced to preparation of the marketing-authorization application for launch in the fiscal year ending March 2026 and expansion into overseas markets. - FY2024RestatedAnnual report
「In June 2021, a project concerning the “Establishment of a stable supply system for human allogeneic cells used as raw materials for regenerative medical products” was selected as an AMED commissioned project. The company has advanced the industrialization of regenerative medicine using domestically sourced allogeneic cells while clarifying the characteristics of a wide variety of mesenchymal stem cells.」
The company continues AMED projects concerning the development of allogeneic cell products, stable supply of cell materials and industrialization. - FY2024-Q2AdvancedAnnual report
「In the clinical trial, treatment of the final patient has been completed and follow-up of all patients has been completed. We will promptly compile the data and prepare the application.」
For allogeneic cultured epidermis Allo-JaCE03, treatment of the final patient and follow-up of all patients were completed, and the company advanced to the stage of preparing the marketing-authorization application. - FY2023-Q2RestatedAnnual report
「Regarding allogeneic cultured epidermis, a ready-made product using another person's skin tissue as the raw material and developed under the name Allo-JaCE03, a project concerning its development and commercialization was selected in August 2021 as an AMED grant project, and the clinical trial notification was submitted in November 2021.」
The company continues its industrialization strategy through the selection of Allo-JaCE03 for an AMED project, submission of the clinical trial notification, and establishment of a stable supply system for allogeneic cells. - FY2022AdvancedAnnual report
「The company aims to realize Japan's first mass-produced ready-made product using allogeneic cells, manufactured and stored in advance for use without delay when needed. It advanced development of allogeneic cultured epidermis after being selected in October 2018 for a three-year AMED national project and conducted clinical research at Kyoto University to treat skin-defect wounds. It was subsequently selected in October 2021 for a three-year AMED national grant project and began a company-led clinical trial in November of the same year.」
Regarding establishment of the foundations for the practical application of allogeneic cultured epidermis, the company began a company-led clinical trial in November 2021 following the AMED project and clinical research at Kyoto University. - FY2022-Q3AdvancedAnnual report
「Regarding allogeneic cultured epidermis, a ready-made product using another person's skin tissue as the raw material and developed under the name Allo-JaCE03, a project concerning its development and commercialization was selected in August 2021 as an AMED grant project, and the clinical trial notification was submitted in November 2021.」
Regarding commercialization of ready-made allogeneic cultured epidermis, following selection for an AMED project, the company submitted the clinical trial notification in November 2021 and advanced to the stage leading to a company-led clinical trial. - FY2022-Q2AdvancedAnnual report
「Regarding Japan's first ready-made product using another person's skin tissue as the raw material, a new project concerning the “Development and commercialization of allogeneic cultured epidermis” was selected in August 2021 as an AMED grant project. Clinical research conducted by the joint research partner Kyoto University through the previous fiscal year suggested the product's safety and efficacy in treating skin-defect wounds with allogeneic cultured epidermis. The company will therefore promptly begin a company-led clinical trial under the AMED project. In June 2021, a new project concerning the “Establishment of a stable supply system for allogeneic cells used as raw materials for regenerative medical products” was also selected as an AMED commissioned project.」
New AMED projects concerning the development and commercialization of allogeneic cultured epidermis and establishment of a stable supply system for allogeneic cells were selected. In light of the indications of safety and efficacy from clinical research at Kyoto University, the company announced plans to promptly begin a company-led clinical trial. - FY2022-Q1RestatedAnnual report
「Regarding Japan's first ready-made product using another person's skin tissue as the raw material, the company advanced two AMED projects from October 2018: “Development of allogeneic cultured epidermis” and “Establishment of a stable supply system for allogeneic cells for industrial use.” In parallel, Kyoto University, the company's joint research partner, conducted clinical research on skin-defect wounds using allogeneic cultured epidermis, accumulating evaluation data for a company-led clinical trial.」
The company continues the AMED project and clinical research at Kyoto University concerning commercialization of ready-made allogeneic cultured epidermis and establishment of a stable supply system for allogeneic cells. - FY2021-Q1AdvancedAnnual report
「Contract date: 1 April 2020. Contract period: 1 April 2020 to 31 March 2021. AMED and the company will enter into a commissioned agreement for the “Project for Developing Fundamental Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Model Project for the Stable Supply of Human Allogeneic Somatic Stem-Cell Materials from Domestic Medical Institutions).” The commissioned work is as follows: “Demonstration of a stable supply of human cells and tissues for the industrial use of regenerative medicine using allogeneic cells.” The project will establish a transparent, sustainable model for stable supply by systematizing donor informed-consent acquisition and screening, applications within medical institutions, and transport arrangements for collection, while clarifying the operational workload.」
Regarding the model for the stable supply of allogeneic cell materials, the company renewed its fiscal 2020 commissioned agreement with AMED and specified the demonstration activities, including systematization of donor consent acquisition, screening, applications and transport arrangements. - FY2020AdvancedAnnual report
「AMED and the company will enter into a commissioned agreement for the “Project for Developing Fundamental Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Model Project for the Stable Supply of Human Allogeneic Somatic Stem-Cell Materials from Domestic Medical Institutions).”」
The company renewed the AMED-commissioned research on establishing a model for the stable supply of allogeneic cell materials for fiscal 2020 and entered into an agreement to continue it through 31 March 2021. - FY2020-Q3RestatedAnnual report
「The company aims to realize Japan's first ready-made product using another person's skin tissue as the raw material, manufactured and stored in advance for use without delay when needed. Since October 2018, it has been advancing two projects as AMED national projects: “Development of allogeneic cultured epidermis” and “Establishment of a stable supply system for allogeneic cells for industrial use.”」
The company continues to advance two AMED projects concerning commercialization of ready-made allogeneic cultured epidermis and establishment of a stable supply system for allogeneic cells. - FY2019AdvancedAnnual report
「Contract period: 1 April 2019 to 31 March 2020. Main contract terms: AMED and the company will enter into a commissioned agreement for the “Project for Developing Fundamental Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Model Project for the Stable Supply of Human Allogeneic Somatic Stem-Cell Materials from Domestic Medical Institutions).”」
The company entered into an agreement to renew and continue the AMED-commissioned research on establishing a model for the stable supply of allogeneic cell materials in fiscal 2019. - FY2019-Q3AdvancedAnnual report
「Contract period: 1 October 2018 to 31 March 2019. Main contract terms: AMED and the company will enter into a commissioned agreement for the “Project for Developing Evaluation Infrastructure Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Model Project for the Stable Supply of Human Allogeneic Somatic Stem-Cell Materials from Domestic Medical Institutions).”」
The company entered into a new commissioned research and development agreement with AMED and began specific research to demonstrate a model for the stable supply of allogeneic cell materials. - FY2019-Q2AdvancedAnnual report
「In September 2018, two projects were selected as national projects commissioned by the Japan Agency for Medical Research and Development (AMED): development of products using allogeneic cells and establishment of a stable supply system for allogeneic cells for industrial use.」
Two AMED projects concerning the development of allogeneic cell products and establishment of a stable supply system were selected, advancing the establishment of the foundations for the practical application and industrialization of regenerative medicine. - FY2019-Q1AdvancedAnnual report
「AMED and we will enter into a commissioned research agreement for the program for developing evaluation infrastructure technologies for the industrialization of regenerative medicine, specifically the development of evaluation methods and other technologies for the industrialization of regenerative medicine. The commissioned project is titled “Development of foundational technologies for rationalizing the manufacturing method for autologous cultured cartilage products.” To rationalize the manufacturing method for regenerative medicine products, the project will automate tissue processing in JACC autologous cultured cartilage and establish an automated determination system for in-process inspections, among other activities.」
As part of establishing the foundations for the practical application of regenerative medical products, the company entered into an AMED agreement covering automation of JACC's tissue-processing process and establishment of an automated judgment system for in-process inspections. - FY2018AdvancedAnnual report
「“Development of Fundamental Technologies to Rationalize the Manufacturing Process for Autologous Cultured Cartilage Products.” To rationalize the manufacturing process for regenerative medical products, the company is automating the tissue-processing process for autologous cultured cartilage JACC and establishing an automated judgment system for in-process inspections.」
The company expanded its research from conventional evaluation infrastructure and product-development research to new AMED research, including automation of JACC's tissue-processing process and establishment of an automated judgment system for in-process inspections. - FY2018-Q3RestatedAnnual report
「The company continued developing multiple products, also utilizing grants from the Japan Agency for Medical Research and Development (AMED).」
The company continues to develop multiple regenerative medical products using AMED grants. - FY2018-Q2RestatedAnnual report
「The company continued developing multiple products, also utilizing grants from the Japan Agency for Medical Research and Development (AMED).」
The company continues to develop multiple regenerative medical products using AMED grants. - FY2018-Q1RestatedAnnual report
「“Basic research and product development of allogeneic cultured skin for skin reconstruction”」
The company continued its commissioned research and development agreement with AMED from 1 April 2017 through 31 March 2018, advancing research into cell banks, quality and safety evaluation, and commercialization methods for allogeneic cultured skin. The agreement concerning mesenchymal stem cells was also continued. - FY2017-Q1AdvancedAnnual report
「AMED and the company will enter into a commissioned agreement for the project “Research and Development of Medical Systems through Advanced Use of Medical Information / Research and Development of a Support System for Predicting the Efficacy of Regenerative Medical Products.” The commissioned work comprises the following: “Characterization analysis of cultured corneal epithelial sheets using corneal epithelial cells and implementation of a company-led clinical trial.” “Establishment of an allogeneic cell bank, development of evaluation methods for quality and safety, and proposal of a method for commercializing allogeneic cultured skin through physician-led clinical trials.” “Determination of culture and quality-control methods for mesenchymal stem cells suitable for ischemic diseases, establishment of a commercially usable mesenchymal stem-cell bank, and compilation of knowledge on related evaluation methods.”」
Under the agreement with AMED, the company is advancing specific research topics covering clinical trials of corneal epithelium, cell banks and evaluation methods for allogeneic cultured skin, and the culture, quality control and banking of mesenchymal stem cells. All contract periods run through 31 March 2017. - FY2016First statedAnnual report
「Two projects submitted by the company were selected under the fiscal 2016 project publicly solicited by the Japan Agency for Medical Research and Development (AMED), titled “Project for Developing Evaluation Infrastructure Technologies for the Industrialization of Regenerative Medicine (Development of Evaluation Methods for the Industrialization of Regenerative Medicine).” The company entered into a commissioned research and development agreement with AMED. Through this project, the company aims to establish the foundations for the practical application of regenerative medical products.」
The company is developing the foundations for allogeneic cultured skin and mesenchymal stem cells, including quality and safety evaluation, culture methods and cell banks.