An R&D project for regenerative medicine products by Associate Professor Daisuke Sakai, Faculty of Medicine, Tokai University School of Medicine, has been adopted for the second round of the call for proposals on seeds for the FY2020 Translational Research program; Strategic PRomotion for practical application of INnovative medical Technology (TR-SPRINT) by the Japan Agency for Medical Research and Development (AMED). Dr. Sakai is a scientific advisor of TUNZ Pharma Co., Ltd.
Details of the AMED-adopted project are as follows:
Project name: Allogeneic nucleus pulposus cell products aiming at the practical use of regenerative medicine for disc degeneration
Period: From August 1, 2020, to March 31, 2021 (subject to change)
For details of adoption by AMED, please visit:
https://www.amed.go.jp/koubo/05/01/0501C_00134.html.
■ Summary of the Project
- Objectives
To establish the quality of final products manufactured by using newly-patented technology and develop a non-clinical study package within FY2021 by completing paperwork prescribed by the Pharmaceuticals and Medical Devices Agency (PMDA), thus paving the way for the commencement of Phase I/II investigator-initiated clinical trials.
- Goal
To leverage the AMED program to accelerate the pace of development of regenerative medicine products in order to deliver the products to the many patients suffering from disc degeneration as soon as possible.
- Project structure
Principal research institution: Tokai University
Co-principal research institution: TUNZ Pharma Co., Ltd.
■ About AMED's Strategic Promotion Program for Translational Research
This program is intended to contribute to the realization of a Japanese society where people enjoy good health and the world's longest life expectancy by reinforcing and developing a framework for promoting translational research throughout the country in cooperation with Clinical Research Core Hospitals designated under the Medical Care Act of Japan, enabling the continuous creation of more innovative pharmaceutical products and medical devices of Japanese origin.
For the purpose of the program, research seeds in different development stages are classified into Seeds A, B, and C, to support research projects by maximizing the functions of respective institutions.
For details of the Strategic Promotion for Program for Translational Research, please visit
https://www.amed.go.jp/program/list/16/01/001.html(in Japanese only).
