Outline Research Clinical Services & Other Works
Home page URL https://www.tmd.ac.jp/grad/rege/

Staffs

Title Name Researcher information
Professor SEKIYA Ichiro
Assistant Professor KATANO Hisako
Assistant Professor Ozeki Nobutake
Graduate Student TANIMOTO Takahiro
Graduate Student FURUOKA Hideto
Graduate Student MATSUTA Seiya
MIZUNO Mitsuru
ENDO Kentaro
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Outline

The development of stem cell and regenerative medicine has been remarkable in recent years, and there is competition to develop regenerative medicine products for the global market. In this field, the aim is to conduct basic research in stem cell and regenerative medicine from the perspective of commercializing regenerative treatments that demonstrate high efficacy compared to existing treatments. This involves enhancing translational research to apply the outcomes to clinical practice, with the ultimate goal of industrialization.
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Research

1) Development of regenerative medicine with stem cells.
2) Realization and industrialization of the cell and regenerative therapy.
3) Establishment of safety test for regenerative medicine.
4) Translational research.
5) Development of software for 3D analysis of knee MRI.
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Clinical Services & Other Works

We have been conducting basic research, translational research, and practical application research to establish a new treatment method for osteoarthritis of the knee. From 2000 to 2010, we clarified that mesenchymal stem cells derived from the synovium (synovial stem cells) have a high capacity for differentiation into cartilage and meniscus, and that their transplantation can promote the natural healing process. We also developed a method for cell transplantation using minimally invasive arthroscopic surgery. These basic research efforts were highly regarded, and in 2013, they were selected as one of the national projects, "Highway for the Realization of Regenerative Medicine" (Project Leader: Ichiro Sekiya), receiving long-term support for the research project aimed at "Regeneration of the Meniscus with Synovial Stem Cells" to establish a new meniscus treatment with less patient burden. After conducting translational research with medium-sized animals, supported by the Ministry of Education, Culture, Sports, Science, and Technology, a physician-led clinical trial targeting meniscus damage using autologous synovial stem cells began in August 2017, with support from the Ministry of Health, Labour, and Welfare. In March 2019, a patent license agreement was signed with a company regarding the technology for transplanting synovial stem cells to the site of meniscus tears. Then, in January 2023, a phase III clinical trial (corporate trial) began to verify the efficacy and safety of regenerative medicine products utilizing this cell transplantation technology.
As a second project, to develop a treatment method through a new administration route of synovial stem cells, a clinical study "Intra-articular Injection of Synovial Stem Cells for Osteoarthritis of the Knee" was conducted from December 2017 to March 2020, supported by the Japan Agency for Medical Research and Development (AMED) regenerative medicine practical application research project. Following the results, a comparative trial against existing treatments as a physician-led clinical trial began in April 2023.
The third project "MRI 3D Analysis" has been supported since 2015 by the AMED's project for developing evaluation technology for industrialization of regenerative medicine. In collaboration with companies, we developed MRI 3D analysis software capable of automatically extracting bones, cartilage, and meniscus from knee MRI proton density-weighted images and T2* weighted images and measuring the thickness of the cartilage. In 2018, the "Kanagawa Knee Study," a survey on the actual condition of MRI for Japanese osteoarthritis of the knee, began, assuming analysis using this software, and MRI data was acquired through a regional resident cohort. Subsequently, in 2019, it was launched as a knee joint analysis application for a 3D image analysis system. Aiming for widespread use in orthopedic research and clinical practice both domestically and internationally, since 2022, a multicenter study to measure the inter-device error using this software has been conducted with five major universities in Japan.
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