Organ Technologies and RIKEN Update

A week ago, important news came out from Japan that the Organ Technologies and RIKEN team (led by Dr. Takashi Tsuji) partnership was making progress in its development of a cure for hair loss that they still aim for commercial release in 2020. The latest update mentions that the team has succeeded in creating equipment that “allows for more efficient mass production of such hair follicle cells”.

They will conduct safety trials on mice starting next month. If all goes well, human trials will commence next year. Since new Japanese laws related to clinical trials are aimed at speeding up the process, it is not out of the realm to aim for a 2020 product release. Especially since this autologous treatment entails using ones own cells (and multiplying them), implying less likelihood of major side effects. Key new quote from Dr. Tsuji:

“The latest results indicate that we have gone beyond the research stage. We will seek to industrialize a technology born in Japan.”

Not Impressed at Speed

A significant number of people posted links about this news; or e-mailed me about it; or criticized me about not covering it and instead focusing on hair systems and celebrity news (I deleted all insulting comments).

While I was very glad to read this positive update from the RIKEN team, I delayed this post primarily because I was not too impressed with the speed of progress in their research and trials. So I first chose to discuss the two new video updates in the previous two blog posts.

I thought that by now the Tsuji team must have already started work in humans. Clearly an incorrect assumption.

Edit: Thanks to “PinotQ” for pointing out the following paragraph from Organ Technology’s press release, which sounds like a big breakthrough:

“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.”

Tsuji Still the Man

We have already known for several years that this RIKEN/Tsuji team aims to release their treatment in 2020. Both of my posts in 2016 that were related to this at-the-time groundbreaking news (see here and here) garnered around 300 comments each. At the time, there was justifiable reason for major excitement. This work represented the breakthrough that we had been awaiting for decades. Moreover, all four parties involved (Organ Technologies, Kyocera, RIKEN and Dr. Tsuji) have great reputations. Each brings unique strengths to the table. Most importantly, funding would never be an issue for this work due to involvement of large corporations as well as the Japanese government (via RIKEN).

Last year, I conducted a future hair loss treatment related poll on this blog. This work, led by Dr. Tsuji’s team, came in as the 2nd most looked forward to treatment that people were most optimistic about. I would definitely rank it as number 1 most important, as would numerous others on various hair loss forums out there.

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82 thoughts on “Organ Technologies and RIKEN Update”

  1. Hello, I have always learned about this site since the beginning of this year. It is my first comment. I live in Korea. This article(Japan’s organ tech) was introduced to Korea last week, and many people were interested. And there are many opinions that the prospects are bright. However, I’m not sure the stability and effectiveness will be guaranteed until 2020. Because 2020 is a very near future. Previously, many physicians and researchers said they would develop a drug within a few years, but it was not realized. What is the opinion of Admin? Do you really predict that the cure will be developed by 2020?

  2. The 1 cm of back of the head skin for 10,000 hair follicles, seems really nice giving hair surgeons a lot to work with, I’ve always been a bit sceptical of Riken, while Tsuji research is very good, no human trials yet and they still say a 2020 release date, it seems really unrealistic at this point in time, I can’t imagine by the time they do two human trials and thus have two read outs of information that they could even get that time line depending on how long each human trial lasts for, 2022+ seems way more logical. (that also depends on if in Japan, one needs two human trials for it to be approved for market release)

    Look at replicel and shiseido they started human trials ages ago one company started 5+years ago and the other last year and yet still no clinical trial read out has been presented by shiseido at this point in time.

    Probably the most interesting thing to take away from this is that all these major companies seem to be using one’s own cells to produce new hair follicles, maybe in the end the new dark horse PolarityTE might be out first.

    1. If you go back to the very first press release, they have always maintained that human trials would begin in 2019, and if successful they would aim for a 2020 release. The rules for release are different in Japan. So they are actually bang on course.

  3. RIKEN is a government funded national science institute
    https://www.youtube.com/watch?v=3YSWODDjIng

    I like Tsuji’s quote saying they are capable of controlling hair follicle size as well as quantity

    IMO I think this organization is going to be the one that validates that name of this blog. I also think 2020 is not hyperbole if we hear their onto human trials next year it’s damn near checkmate.

  4. Two years is quite short, yes. But this short timeline is much more solid and safe to predict than all the other announcements like “available in 5 years”. Thats why I am quite positive for this and companies like Medipost, Polarityte and maybe even still Brotzu (who knows :-) ). And dont forget all the former disappointments like Samumed, Replicel, Follica, Cassiopea and (Newcomer) Follicum are getting there finally.

  5. “And dont forget all the former disappointments like Samumed, Replicel,” QUOTE

    John, why do you say Replicel is a disappointment. I thought the Trials have finished yet so I hope we’ll be informed about the success until septembre… Do you have any new Informations?

    1. @ LeeB I am quite sure they will soon have good results. My comment was only concerning the delays until now. I dont know anything more than everybody else here.

  6. Two years does seem like a very tight time frame although to me the key piece of information, from the Organ Technologies PDF, is this: “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.” If this is true, and I assume they know this by analyzing the cultured cells, the most difficult part of the puzzle has been solved.

  7. Hey Admin,

    Thank you so much for doing this research and being the best source for hair developments on the web. My hair problems have made me depressed, but if it wasn’t for finding this blog and knowing there’s still hope and is the few things keeping me from being in a very bleak place.

    I’ve still got a good amount of hair and can hide the worst of things. Although I’m opting not to take the risk of taking fin (any risk of killing my personality is too high), and I preferably don’t want to take minidoxinal (due to already have a low blood pressure), so it’s reassuring to know thanks to these developments you’ve researched any period of termoil for me will be short. If these treatments start off as only being available in Japan I’ll be on the first flight over there.

    1. Your personality has already changed thanks to this damn baldness …
      you should try Finasteride before losing too much … if you see unwanted changes … you can always stop. I’ve been on finasteride for over 10 years and I’ve never felt any major side effects … do not forget that depression kills sexual desire more than anything.

  8. Hey guys you think this suppose it cure will be available for people with DUPA DEFUSED UNPATTERNED ALOPECIA like me or am I out of luck and stuck being bald. Just wondering what people think. Thanks

    My baldness is only 5% of the population. Thanks

    1. That is a very good question.
      I am also a DUPA sufferer.
      Means donor zone is not safe, yet most dupa sufferers (my older brother and dad) still have hairs on the back of the head, and though that haircount declines over time, it will not become 0.
      So I wonder if the quality is good enough for what Tsuji’s approach. Otherwise we are out of luck I assume…

      1. I think JAK may be of use. Mine is a mix of traditional mpb but as it got very aggressive very fast its started to take a more unpatterned nature and my inflammation biomarker has gone up. The hope is that JAK has some sort of assistance for these different types of alopecia which likely have roots linked to inflammation.

  9. Apologies if the question is off topic, but I have been researching temporary scalp micro-pigmentation.

    Would getting treatment like this have any effect towards future treatments like this one?

    I didn’t want to email the admin and have been trying to find other opinions before going through with it. I’m also a diffuse thinner on the big 3.

    Thanks

  10. Hi folks newbie here first post .I just wonder is there be an estimate of the cost ? For example slick bald to a full head of hair . Thanks

  11. Hey my bold friends this is an OT-Post

    My question is: what is the current Situation with Bodyhairtransplantation?
    In my Case i have very nice chest Hair (Chewbacca aww aww), the Hair in my chest is almost thicker than on my back head.
    I barely can find doctors or results in the internet, but on many websides there are information that it can Work and that even the bodyhair Changes by time and adopts the head Hair.
    Are there any good doctors for Body Hair in Europe?
    I already had an ht in turkey and i didnt helped much on by Back head. In the Front its okay. So i want to make one more to fill in but with my chest Hair…

    1. Find a top doctor who specialises in FUE and Body Hair Transplant too. I have seen some results whereby BHT mixed with donor area has looked pretty good but the opposite also. Skill of surgeon is essential. Hope this helps :)

  12. As a dermatologist and skeptic who has been active in this space and who has treated thousands of patients for hair loss, this is the most promising news of a near-term robust treatment for male and female pattern hair loss that I have seen.

    1. Also- something that everyone is missing here regarding the timeline is that this is not a drug. These are the person’s own cells. This could speed up regulatory approval. Just like how PRP never had to get FDA clearance, this product *may* not have to either. Usually it takes 10+ years to go from an animal model of a drug to commercialization. This could be faster.

      1. Anon…what do you recommend a long time user of Propecia to do when it stops working. I’m on Rogaine and it’s not really holding up. Been on Propecia since 2002. My hair is diffusing out slowly but steady. Propecia stopped my loss till about 2013ish. Any recommendations to boost effectiveness again?

        1. Im in the same boat, almost exactly same time frame as you…hoping someone has any suggestion about boosting its effects once they begin diminishing

          1. Exactly is autologous and in Japan so no phase 2. They can control quantity and thickness. I can’t think of any competing company besides maybe polarity but they haven’t even announced

    1. Haha yes I did. Changed twice to different shades of blue. Someone told me that I should use a different template as this is a common one, but I like the layout of this one…so I just changed the border color instead for the time being.

      I prefer the older black one, but am hoping to get used to this blue one. What do you think?

      1. I prefer the black one.

        If you made it a darker blue I think that would work better.

        The blue now is too light,and with the font it gives off a 1990s computer website vibe haha.

        Glad to see you try new things though!

    1. Wouldnt that be some s if we did have a cure and all became fullheads and the admin had one final post. Just saying “we made it”. Everyone who ever posted could come by one last time to say goodbye. Our hellish journey comes to a happy ending.
      Id miss you guys. Bittersweet

    1. Thanks. Strange that they barely update he Follica Twitter account or say anything about Follica on the Puretech Twitter account.

      1. Yes……true to past form there isn’t much directed toward the public……….mostly just updates geared toward the investor side. At any rate, I put it in the plus column.

  13. Hi all,

    I can’t do about but masturbation is definitely a problem for male baldness. Also i saw a guy who had a liver transplate and his hair did grow back. So baldness has got to with the liver too.

    In that case would the cure be safe if something else plays a role too ? Thank you.

    1. Of all all the alternative “cures” I’ve seen tested and failed the only one ive never tested or seen was the liver detox do you have a reference to the liver transplant story?

  14. Something profound behind the riken Tsuji connection is that he started with AGA follicle cloning because follicles are organs he said they wanted to start small to move into larger organs. This is incredible because george church Harvard figures apparently aren’t aware of this type of innovation. This could side step pig organs in the future.

  15. How will the many promising treatments — Riken, Replicel, etc. — that are based on culturing/cloning cells in vitro for later implantation work for men who have (or had) strong natural growth patterns like curls, waves, cowlicks, or natural parts? The straight hair produced by follicles toward the nape of my neck ain’t going to look right in front where it curls, you know?

  16. Are they planning to generate new “cells” or “follicles”? If they make cells, then hair growth direction and possible cancer are an issue. If they create new follicles, then it’s the same as a hair transplant, and this thing should proceed asap! I’m really hoping for the latter. Can anyone please clarify??

    1. Generating new “cells” is something the body does anyway, continuously until the day you die. You are already greatly exposed to getting cancer should this process, in any part of your body, at any time in your life, cease to function correctly. Could happen 40 years from now, or next week. Cancer is the one disease that unites us all. Every ethnic group of human, every species of animal, every type of plant. Even an unborn foetus can get it.

      Cloning a few hair follicles will make little difference in the grand scheme of things and such treatments have to meet safety standards anyway first before determining if they will even work. An example being Replicel’s phase 1 success for safety. Great, no tumours will grow, but how about some hair?

      As for hair growth direction, this was a concern of mine when I had my hair system installed (Norwood 6 to 1 now) as I wanted all the hair to go forward instead of in the system’s default spiral pattern. They just gave me a hairbrush. It did the trick.

      1. @scott.. I know that people get cancer independent of this topic, but thanks for explaining. My concern was Riken’s new technology that could promote a different type of cancer growth by injecting cells to promote follicle growth in the body. This technique requires extensive testing to ensure it doesn’t cause cancerous cell growth.

        Next, my concern with hair direction is not like your hair system. Instead, I’m talking about follicle growth in the skin showing in random directions, which would cause ingrown hair health issues and look terrible.

        Anyway, to multiply completed follicles in vitro would solve the above problems and require much less safety testing, which is why I asked if anyone knows the Riken method. It doesn’t seem that anyone knows.

        Full follicle multiplication outside the body seems like the safest “cure” to me. At that point, it’d be similar to getting a hair transplant.

  17. I just did copy and paste on an article from last year… it’s always nice to read and it gives us a lot of hope;)

    1. This is why I did videos for my before and after hair system instead of still images. This just raises too many questions, the most pertinent one being – is it even the same person?

    1. Replicel is injection of dp stem cells in hopes to proliferate hair induction.

      Riken is injection of follicles cloned in culture from occipital region.

      Shiseido clones cells riken clones full follicles.

      1. Wouldn’t full follicles be more of an “implant” than an “injection”? Are you using the words interchangeably? If Riken makes fully formed follicles outside the body, that’d be amazing and should be safe!! It’s basically like a hair transplant with unlimited donor hair.

  18. “I just wanted to share the last email that Dr Vickers sent to me. It just goes a bit into what his background is, how he makes the product and shipping overseas.

    Hi Georgina,
    Thanks for the kind reply. The reason I moved into the hair loss research was probably my own vanity and hair loss (yes even male doctors have vanity!). My background is complex head and facial pain and I have to use stem cell therapy where other treatments have failed. Unfortunately some 50% of my patients consider suicide as their only way to be free of pain. I published the first trial of stem cell therapy to treat this type of pain in 2014. The female with the regenerated face in the ppt presentation is one such case – she described herself as ‘unrecognisable’. Regenerating the face in that patient prompted some scientists to challenge me on fixing hair loss, so I accepted their challenge.
    Both thymulin and zinc had been researched before, but surprisingly the original researchers only conducted preliminary thymulin research on mice. I went further with the human trial and chemically bonded zinc to thymulin in a simple and safe way (using acetic acid – weak vinegar). I am also qualified in herbal medicine and there are some excellent polyphenols (active components of herbs) that improve the zinc-thymulin a great deal. I’m very involved in using natural compounds instead of pharmaceutical drugs with side effects.
    I’m hopeful if there is interest in the product then scale up manufacturing would dramatically reduce the cost of ZT, currently I have to make it myself in my own time (I have extensive peptide chemistry experience so I can do it). Also if it can be classified as a cosmeceutical then it should be ok to ship to most countries. There are already many cosmeceutical peptides found in the expensive facial skin creams in department stores around the world.
    The ZT and the preservative (natural benzoic acid) are in a powder form. Add powder and distilled water to your spray bottle and apply to hair – that simple. Also very safe for kids and toddlers – no harm at all if swallowed, it actually would improve their immune system – that its main function in the body.
    The 3 components to hair loss is the alpha reductase problem, neuroendocrine thinning fat layer, and loss of thymulin signalling. Each person its probably a combination of the 3 and developing a test to find out the relative contribution would certainly improve the success rate of hair loss for everyone.
    hope that helps,
    regards
    Dr Russell Vickers “

    1. Thanks Fadi for that. He seems genuine in his response and belief and lets hope it can help more people too even if not all.

      1. also important that he mentioned the thinning fat layer which seems to be left out a lot of research/articles yet it’s a crucial development which takes place as hair loss advances

  19. Regarding Updates: Aclaris MUST know by now if JAK is working. I think they have a conference call in early August we might find out then if it’s not working or is working. At this point I know longer want to speculate I just want to know if they are getting positive results and if those results are good enough to continue.

    1. @ Nasa_rs,

      Likewise, I am following attentively all Aclaris’s conferences. I have a hunch that they know that something will definitely work, as otherwise they won’t bother to trial jaks in various formats and dosages.

      Apart from the ongoing trial, there has been another mention of soft jaks. The current trial, is the same as the topical trials for Alopecia Aerata, but let’s not forget about the acquisition of Confluence, which brings soft jaks into the hairloss scenario.

      From what I have sensed so far, Aclaris’s strategy is to move from product to product when it comes to marketing. Now that Eskata is ready to take off, their next in line product is the one concerning warts. In the meantime they are busy experimenting and testing jaks for Androgenetic Alopecia.

      This doesn’t seem to be the typical way forward of startup companies. Yet Aclaris has chosen this strategy, and I cannot fathom why should they concentrate efforts, time and investors’ funds to carry forward trials for Aga, if they aren’t so positive, when they have a myriad of other conditions such as Psoriasis and Vitiligo that can turn into a massive cash cow for the company.

    2. Hey Nasa_rs! Yup, unless they have quietly abandoned the study, I think they have something! Recall what Christiano said:

      “It’s gonna be a quick go / no-go; there won’t be a lot of mystery. If they work like they work in AA, it’s obvious. So it’ll be a quick time-to-failure, which I don’t think is such a bad thing either; no reason to prolong it if nothing looks like it’s working.”

      “It’s been a long time, [since the Sonic Hedgehog agonist], since I’ve seen anything in the literature that can turn on a hair cycle as quickly as these do.”

      They know—and I bet for some time now—but what they know I cannot say.

      1. Toccata & Malcome – we should hear soon either way. I agree with Christiano it either works or not at all. Actually the longer we Don’t Hear Anything the better since if it does not work they probably will say they stopped the trial. These are dangerous drugs can’t keep people on them if they are not working.

        1. Nasa_rs, lets not foget that soft jaks have not been trialed yet. And Aclaris still intends to go forward with their development.

          1. Aclaris IS trying soft JAK’s (even though I have no idea what soft JAK’s are).

            For now NO news might be good news.

  20. Hello guys! Quick question, so I had an unsuccessful hair transplant in turkey (my fully trustful doc told me that I could use hair concealer without any problems after 3 month, which surprise surprise turns out you can’t) …the question is now whether this riken technology works on the skin where there the doc operated on. Any ideas?

  21. Nasa, malcom, toccata
    Question for you guys, you may or may not know the answer. (Since the safety of these drugs have been tested before, im not going to even mention phase 1…. )
    But, is it normal for a company to take a drug into phase 2 without knowing if it will or will not work? I cant imagine a company spending all the costs that come with a trial if they are basing success on a hunch only. I know phase 2 will give readouts, but dont you have to be pretty confident it will work to go into a major trial? Am i being naive?

    1. @Champy,

      I’m no corporate expert, yet on my books, it wouldn’t make sense to progress with a trial, unless there are some positive indications that Jaks could work for Aga too.

      My reasoning is made up in this direction, because it wouldn’t make sense to trial the same version of Jak inhibItor that has already been trialed for AA, unless they have some intel in this regards.

      Moreover, for the first time in hairloss history, Aclaris is not just trialing one type of jak inhibitor for Aga, but they are olso developing soft jaks to trial for aga too, this info is available on Aclaris’s pipeline.

      1. So Malcolm, you’re saying they are running a jaks trial now, and it will be followed soon by a soft jaks trial too? Im not sure wht the differences are, but by all means i hope they test every theory/product they have.

        1. According to Aclaris Pipeline page, the current trial is the same used for AA, maybe they tweaked the formulation and dosage range for all I know.

          But further down the pipeline, soft jaks are mentioned independently or the current ongoing trials, and one of the conditions mentioned is definitely Aga.

          There’s nothing to cheer yet, apart form the fact that one company is not focusing on just one single treatment for our situation. However, all I can say, is that these are really interesting times we’re living in.

  22. if jak do not work,then i think no drug will make sense since JAK grows nearly 100% hair in AA and proves extremly effect on mice hair. i have dupa which may not benefit from Tsuji even it success,so aclaris is my only hope

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