Greetings
Tokai University School of Medicine conducts research into regenerative medicine, which holds great promise for overcoming various diseases and injuries. Regenerative medicine uses cells, which are cultured, expanded, and processed before being transplanted into patients. However, living cells cannot be sterilized, so a cell processing center (CPC) is required where cells can be safely cultured in a clean environment. To safely implement regenerative medicine, we utilize CPCs for clinical trials, advanced medical care, and clinical research prior to becoming a covered treatment, within the scope approved by the Medical Ethics Committee and the Ministry of Health, Labor, and Welfare.
Cell Processing Laboratory
Masato Sato
Overview
Purpose of Cell Processing Laboratory
Cell Processing Laboratory is a sub-organization of Clinical Support Division the Faculty of Medicine Hospital, and is one of the facilities that supports regenerative medicine (including clinical research) on campus. Commonly referred to as the Cell Processing Center (CPC), it refers to a strictly controlled cell processing facility for aseptically cultivating and processing human cells for treatment. Established in 2003 on the third floor of Faculty of Medicine Building 1, it is operated as a hospital facility in accordance with hygiene management standards.
Cell Processing Laboratory installation standards
As a facility conducting clinical research using human-derived tissues and cells, our facility undergoes validation in accordance with pharmaceutical GMP. Specifically, we operate based on the three GMP principles of "contamination prevention," "prevention of human error," and "quality assurance." As a facility handling human cells, we strive to operate within social frameworks in consideration of various guidelines. In particular, we conduct clinical research while adhering to the standards for regenerative medicine providers and cell culture and processing facilities established by the Act on the Safety of Regenerative Medicine, etc., which came into effect on November 25, 2014. Regarding facilities, we have completed and accepted notification to the Kanto-Shinetsu Regional Bureau of Health and Welfare (May 20, 2015), and have been assigned facility number FC3150164 as a cell culture and processing facility.
Cell Processing Laboratory configuration
Head: Professor Masato Sato (concurrent post)
Ongoing regenerative medicine provision plan
・AMED Regenerative Medicine Practical Research Project
"Completion of advanced medical treatment for knee osteoarthritis by autologous cell sheet transplantation" R3 to R5
"Investigator-initiated clinical trial to verify the effectiveness of intra-articular injection of platelet-rich plasma (PRP) for knee osteoarthritis: A multi-center randomized double-blind comparative study" R4 to R8
URL: http://cellsheet.med.u-tokai.ac.jp/
Principal Investigator Professor of plastic surgery Masato Sato
Allogeneic cartilage cell sheet transplantation was accepted as a Type 1 regenerative medicine provision plan (April 28, 2016) and began. Currently, transplantation has been completed in 10 cases, and the progress is being monitored.
Autologous chondrocyte sheet transplantation was accepted as a Type 2 regenerative medicine provision plan (March 11, 2016). After its safety and effectiveness were evaluated, the Ministry of Health, Labor, and Welfare's Advanced Medical Technology Review Committee and the Advanced Medical Council deemed it "suitable," and its implementation at our hospital was approved as Advanced Medical Care B from fiscal year 2019. Currently, autologous cell sheets have been transplanted into 18 patients with knee osteoarthritis, with good progress. Additionally, PRP/APS therapy for knee osteoarthritis is currently being implemented as an out-of-pocket medical treatment under the Act on the Safety of Regenerative Medicine, etc., as a Type 2 regenerative medicine provision plan, and specific cell processed products are being produced for use in the treatment. Furthermore, an investigator-initiated clinical trial will begin in fiscal year 2022 as an AMED project.
Clinical research projects carried out so far
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Ministry of Health, Labour and Welfare Science Research Grant Regenerative Medicine Practical Research Project
"Clinical research aimed at joint treatment using cell sheets"
Principal Investigator Professor of plastic surgery Masato Sato -
AMED Regenerative Medicine Practical Research Project
"Realizing regenerative medicine using cell sheets to accelerate joint treatment"
Principal Investigator Professor of plastic surgery Masato Sato
"Realizing regenerative medicine for knee osteoarthritis using allogeneic cell sheets"
Principal Investigator Professor of plastic surgery Masato Sato