Japan’s new laws to fast track stem cell therapies (benefitting Shiseido)

On November 20th 2013, Japan’s parliament passed two groundbreaking laws that aim to speed up the approval process for regenerative medicine involving stem cells.  Much more details here , here and here.

Japan has been at the forefront of regenerative medicine research for a number of years, partly due to the fact that its population is rapidly aging (and declining too).  The country is also at the forefront of robotics related research for similar reasons.  Here is a 2013 article from Japan that projects stellar growth in the local and world market for regenerative medicine.

One  the country’s foremost scientists, Dr. Shinya Yamanaka  (together with the keratinacious Dr. John Gurdon), received a Nobel Prize in 2012 for his discovery on how to transform ordinary adult skin cells into cells that act like embryonic stem cells and can then develop into virtually any other type of cell in the body.  Dr. Yamanaka called these cells induced pluripotent stem cells, or iPS cells.

Japan is now leading the world in this area.  In September 2014, Dr. Masayo Takahashi’s team became the first one in the world to use iPS cells in order to restore eyesight.

What does all this mean when it comes hair loss research?

It looks like time consuming stage III clinical trials that we see in the US will essentially be skipped in Japan.  This is excellent news, especially since Shiseido (Japan) will be starting stage II clinical trials of Replicel (Canada)’s RHC-01 product in the first half of 2015. These trials will last for one year, and it is therefore even possible that Shiseido can bring this product to market in Japan as early as 2017 (assuming the stage II trials show good results). This is a best case scenario of course.

Japan is holding the important BioJapan 2014 World Business Forum this coming week, and Replicel is scheduled to present there on October 15, 2014.  More importantly, Replicel’s team “will be meeting with Shiseido to discuss progress on their RCH-01 clinical trial and to view their purpose-built facility on Kobe Island.”

I have mentioned this a few times before on this blog, and am getting even more convinced that we in the west will have to travel to Asia when the treatment finally arrives, even if it is based on western technology!

Also see Seeking Alpha’s October 10, 2014 write-up on Replicel stock.  FYI — I do not own any REPCF stock and am not advising readers on buying or selling it.  I have zero expertise in the finance or biotech industries.

12 thoughts on “Japan’s new laws to fast track stem cell therapies (benefitting Shiseido)”

  1. with a 14.5% increase in terminal hair and 20% increase in density in its phase one, Replicel is looking decent right now… but still is far away from a cure… and it’ll come out commercially in 2018… Hopefully the auto-immune topicals will work better…

    Any information on Chlorine Dioxide? it’s been all the rage on forums lately.

  2. Hi Bald@21, Yes that kind of growth is not great, but in my earlier post I mentioned that hopefully the results improve with higher doses and longer periods of application.

    I have been in touch with the Chinese guy selling that product with chlorine dioxide, but want to be cautious for a while before I write something about it. Learnt my lesson from my posts on Dr. Nigam’s work:-(

    Also have around 5 other important posts on the backburner, including something on CB-03-01. Wish this blog was part of my day job!

    1. If this is commercially available in Japan 2018. Or wherever, I am flying there & getting this procedure done. Do you think it will be affordable? Cause with the FDA approval process in the US, this can take another 10 yrs.

      1. usa sucks for helping men with hair loss .My hair loss started when to women came over to my place and they used my restroom and my next showerI took left my hair an scalp and face very oily and has been driving me crazy to yhe point of a break down or suicide as I used to look very handsome with my hair healthy and full I want to inform as many men as I can because I see this oily look on so many men and they are loosing hair it looks plain sickly. Please be aware of this guys ,women think hair is more impoertant to them but if you notice it is always a female those words come from . They are just playing stupid on the fact of how important it is for a mans looks too.

  3. I think you need to change the title of your blog 🙂 2018 is just two years away from 2020 and replicel is no cure even if it comes out successful. I do think balding will be cured by stem cells, but i’d give it another 30 years as a conservative estimate. It’ll be another decade before they make new follicles, and then add another twenty for refining a solution and testing it….

    1. so, you’re basically saying that this research will benefit the next generation, and not ours,right? not that I think you’re completely right, but still, it makes hair loss folks even more despondent. too bad that asa a species, we are so slow to bring beneficial things to life, and so quick to develop weapons, junk food, and everything we shouldn’t be using. gotta laugh at that

  4. Why are you all talking about 2018?
    Commercialisation is even possible after showing safety DURING phase 2, that’s what the new regulations in Japan are saying. They wouldn’t have to wait until the trial is finished. Therefore, earliest possible date is early 2016. Please show evidence if you want to contradict me.

  5. Muhammad, that is truly a best case scenario. In reality, companies and governments always seem to take longer then expected in processing information and making decisions at each step. The new Japanese regulations are also being modified with time, and probably not yet set in stone for all types of cases.

    1. Japanese researchers and physicians are far superior to american ones. much more open, and it seems that research dos at a good clip, and enjoys support from most all.

  6. So far the results looks fair, not a stand alone solution. I would try it when it comes out. I do really hope it wont cost 10k per procedure.

    My question is when its going to be possible to transform a NW7 into NW1-2 considering the current progress of hair loss treatment? Unfortunately not in 2020…

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