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- 820
Hello! I am Fuji Maru Kagurazaka.
I live in Tokyo, Japan. Thank you.
Then, it is about the present situation of the early approval system of regenerative medicine in Japan.
Regarding new drug development, I think that it is extremely difficult without much different from the standard of the United States.
However, regarding regenerative medicine, I feel that it is rather loose.
The following is an example.
It is the implementation status of "Kerastem Hair Therapy" by Kerastem.
SEISIN COSMETIC CLINIC in Tokyo on September 26, 2013 has begun recruitment of subjects in clinical trials.
September 26, 2013 News release
"Guidance for recruitment of hair treatment monitor by adipose-derived stem cell transplantation" (Tokyo Initiative only)
https://www.biyougeka.com/news/2013/352/
And on April 16, 2015, treatment is started at SEISIN COSMETIC CLINIC nationwide eight hospitals.
April 01, 2015 News release
"Kerastem (KERASTEM) hair regeneration April 16 th (Thursday) 2015 ~ 8 CLINIC· practice start! "
https://www.biyougeka.com/files/3013/9962/1484/20131015.pdf
The period from recruitment of subjects to complete implementation in the same hospital was 1 year 6 months and 21 days (567 days).
And important thing is that it can be carried out in the independent examination of the hospital without delegating to a third party.
Therefore, in Japan, regenerative medicine is not described as an exam. It is research.
It is much earlier than in the United States.
I live in Tokyo, Japan. Thank you.
Then, it is about the present situation of the early approval system of regenerative medicine in Japan.
Regarding new drug development, I think that it is extremely difficult without much different from the standard of the United States.
However, regarding regenerative medicine, I feel that it is rather loose.
The following is an example.
It is the implementation status of "Kerastem Hair Therapy" by Kerastem.
SEISIN COSMETIC CLINIC in Tokyo on September 26, 2013 has begun recruitment of subjects in clinical trials.
September 26, 2013 News release
"Guidance for recruitment of hair treatment monitor by adipose-derived stem cell transplantation" (Tokyo Initiative only)
https://www.biyougeka.com/news/2013/352/
And on April 16, 2015, treatment is started at SEISIN COSMETIC CLINIC nationwide eight hospitals.
April 01, 2015 News release
"Kerastem (KERASTEM) hair regeneration April 16 th (Thursday) 2015 ~ 8 CLINIC· practice start! "
https://www.biyougeka.com/files/3013/9962/1484/20131015.pdf
The period from recruitment of subjects to complete implementation in the same hospital was 1 year 6 months and 21 days (567 days).
And important thing is that it can be carried out in the independent examination of the hospital without delegating to a third party.
Therefore, in Japan, regenerative medicine is not described as an exam. It is research.
It is much earlier than in the United States.
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