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So as some of you know Riken will start human trials next year, for the HF Primordiums treatment, developed by Dr. Takashi Tsuji.
This new treatment is probably our best chance for a cure in the next following years, however nothing is guaranteed since nobody knows if the treatment will work in humans. Unfortunately we already saw several treatments working in mice, that failed when applied to humans.
I made this thread, for the community to start discussing the possibility of a 2020 release date, and to share new updates regarding Riken's treatment.
So, do you believe in a 2020 release date (in Japan)? Are you optimistic about this new approach?
(sorry for the bad English, but is not my native language)
--
October, 2008
https://www.gov-online.go.jp/eng/publicity/book/hlj/html/201810/201810_10_en.html
Regenerative medicine is at the core of twenty-first century medical treatment and it is strategically important for Japan to develop this high-value industry.
“We pursue innovations in this area of research and development at a world-class level, and it is our mission to make it happen both within and beyond Japan,” Tsuji and Sugimura agree. “Regenerating hair follicles is the beginning of that road, and after preclinical and safety testing our goal is to implement it by 2020. Starting by curing baldness, our intention is to develop an industry aimed at improving quality of life.”
June, 2018
Problems and solutions for clinical application to humans
There were two major challenges to applying hair follicle regeneration technology to humans. 1) The need to develop an in vitro amplification method for epithelial stem cells and dermal papilla cells Previously, epithelial stem cells had not been identified, and it was known that the hair follicle regenerative capacity of cells disappears while cultured in vitro. However, we have overcome these problems with mouse and human cells after research activities over 7 years. 2) The development of a robust method for the mass production of regenerated hair follicles Conventionally, regenerated hair follicles were produced manually by compartmentalizing two types of stem cells into a collagen gel at a high density in a cell suspension of ten thousandth of a milliliter. Therefore, it was very difficult to stably mass-produce regenerated hair follicles, and we needed to develop a new technology to overcome this for the clinical application. We succeeded in developing this technology with collaborative research with Kyocera Corporation, which began in 2016. With the success of these developments and by overcoming the other challenges to carrying out clinical research, we have advanced to the P0 stage (preclinical testing) in RIKEN Program for Drug Discovery and Medical Technology Platforms. Based on this program, RIKEN is playing a role in the preclinical research and academic validation of the amplification and cultivation technology of human cells. Organ Technologies, Inc. will establish the manufacturing and quality-control system for conducting the preclinical tests. Kyocera will provide novel methos for manufacturing regenerated hair follicles.
Schedule
Under the plan, we will begin manufacturing samples for preclinical tests in July 2018 and we will conduct preclinical safety tests using animals. We plan to complete the safety testing in 2018. If the results of the preclinical safety tests are successful, we will apply for clinical research to the Certified Special Committee or Certified Committee for Regenerative Medicine. After receiving approval from the Committee, we will present a provisional plan to the Minister of Health, Labor and Welfare, and will shift toward implementation of clinical research. The details of the clinical research will be announced before the initiation of the research.
This new treatment is probably our best chance for a cure in the next following years, however nothing is guaranteed since nobody knows if the treatment will work in humans. Unfortunately we already saw several treatments working in mice, that failed when applied to humans.
I made this thread, for the community to start discussing the possibility of a 2020 release date, and to share new updates regarding Riken's treatment.
So, do you believe in a 2020 release date (in Japan)? Are you optimistic about this new approach?
(sorry for the bad English, but is not my native language)
--
October, 2008
https://www.gov-online.go.jp/eng/publicity/book/hlj/html/201810/201810_10_en.html
Regenerative medicine is at the core of twenty-first century medical treatment and it is strategically important for Japan to develop this high-value industry.
“We pursue innovations in this area of research and development at a world-class level, and it is our mission to make it happen both within and beyond Japan,” Tsuji and Sugimura agree. “Regenerating hair follicles is the beginning of that road, and after preclinical and safety testing our goal is to implement it by 2020. Starting by curing baldness, our intention is to develop an industry aimed at improving quality of life.”
June, 2018
Problems and solutions for clinical application to humans
There were two major challenges to applying hair follicle regeneration technology to humans. 1) The need to develop an in vitro amplification method for epithelial stem cells and dermal papilla cells Previously, epithelial stem cells had not been identified, and it was known that the hair follicle regenerative capacity of cells disappears while cultured in vitro. However, we have overcome these problems with mouse and human cells after research activities over 7 years. 2) The development of a robust method for the mass production of regenerated hair follicles Conventionally, regenerated hair follicles were produced manually by compartmentalizing two types of stem cells into a collagen gel at a high density in a cell suspension of ten thousandth of a milliliter. Therefore, it was very difficult to stably mass-produce regenerated hair follicles, and we needed to develop a new technology to overcome this for the clinical application. We succeeded in developing this technology with collaborative research with Kyocera Corporation, which began in 2016. With the success of these developments and by overcoming the other challenges to carrying out clinical research, we have advanced to the P0 stage (preclinical testing) in RIKEN Program for Drug Discovery and Medical Technology Platforms. Based on this program, RIKEN is playing a role in the preclinical research and academic validation of the amplification and cultivation technology of human cells. Organ Technologies, Inc. will establish the manufacturing and quality-control system for conducting the preclinical tests. Kyocera will provide novel methos for manufacturing regenerated hair follicles.
Schedule
Under the plan, we will begin manufacturing samples for preclinical tests in July 2018 and we will conduct preclinical safety tests using animals. We plan to complete the safety testing in 2018. If the results of the preclinical safety tests are successful, we will apply for clinical research to the Certified Special Committee or Certified Committee for Regenerative Medicine. After receiving approval from the Committee, we will present a provisional plan to the Minister of Health, Labor and Welfare, and will shift toward implementation of clinical research. The details of the clinical research will be announced before the initiation of the research.
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