A Truly Outstanding Week in Hair

As if my last post on Dr. Terskikh’s progress and new company was not enough, three other new developments occurred last week that were extremely encouraging.

Follicum Positive Phase IIa Results

“The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can “awaken” dormant hair follicles.”

I have mentioned Sweden-based Follicum numerous times in the past (see all Follicum past posts). Of the 50 plus companies that I have covered on this blog in the past five years, Follicum has been the most professional in my opinion (at least when it comes to companies based in the western world).

This week, the company announced Phase IIa trial results.

Also, CEO Jan Alenfall gave a much more detailed interview discussing these results.

The quote that I posted above in red is the best part of these results. So now we have yet more evidence that long-lost miniaturized “dead” hair can be reawakened.

There are some issues regarding appropriate dosage levels. Follicum plans to test higher dosages in the next phase of trials. In these Phase IIa results, the highest dose resulted in an 11% median increase in the number of hair follicles in growth phase.

Maintenance of existing hair and an 11% increase in new hair would be amazing considering that this FOL-005 product did not cause any side effects (all too common with Finasteride and Dutasteride). Here’s to hoping for even better results with higher doses.

Samumed Initates Phase 3 Trials

In its latest monthly newsletter, Samumed announced that:

Samumed Phase 3 Trials

Not a big surprise considering my August 2018 post on Samumed’s pending Phase 3 trials. Wonder in which country they are holding these trials?

Dr. Takashi Tsuji Still Aiming for 2020

Thanks to “Winston” for finding this Japanese government website link update on Dr. Takashi Tsuji’s work. The doctor is partnering with Kyocera, RIKEN and Organ Technologies, so those companies also need to be mentioned. Key quote:

“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.”

I would want nothing more than an end to baldness and a cessation of my writing these posts after December 31st, 2020. Dr. Tsuji is my number 1 hope of making this happen. He has the requisite intelligence, ethics, drive, decades of research experience, corporate funding and government support.

Addendum: A few people posted comments or e-mailed me about new UK-based hair regeneration company btechlaboratories (since Fuji Maru from Japan covered this company recently). However, btechlabs currently has an insecure (non-https://) website with bad quality writing and layout. And their Twitter link goes to a host provider’s Twitter account. I would expect my readers to be a bit less gullible.

 

 

47 thoughts on “A Truly Outstanding Week in Hair”

  1. So in that “beginning of the road” comment, have they actually created a stable and scable hair follicle or are they no further than the glowing hair implanted on that mouse?

    1. I think he may be implying that hair is just the beginning of the road in their goal to tackle aging and improve human quality of life. They are aiming for much more than just hair. Tsuji himself is also trying to regenerate teeth and salivary glands. Japan is trying to regenerate everything in the human body due to the country’s double whammy of a rapidly aging society and low birth rates. The article might also have had some translation from Japanese into English, although I am not sure.

  2. We just need one to work. The more the better but just one that works and as soon as possible.

    Plus I am still waiting to hear about JAK results from Aclaris. They might announce any day now on if it works or not.

    nasa_rs

  3. I think once an effective treatment comes out there will only be MORE to write about! The differences between different treatments, dosages, and why some work better on some patients than others. Basically, I really enjoy what you write in here admin and I hope you’ll keep it up even after we see some success!

    1. Thanks Daniel! I might be truly burnt out by then…may switch to writing about Japan flights, restaurants, accommodation and entertainment options if Tsuji really does do it :-)

  4. Amazing work admin! I’ve been following this blog for ages now and you truly are a legend that makes sure I’m up to date with everything!

    Only problem I have now is if I hop on fina, which I’m really really afraid of. Or, ride it out, hope to hold on to enough of my hair to safe with further treatment. I honestly don’t know..

  5. First timer here woth a quick (and possibly ignorant) question about growth percentages: do they refer to the affected area, or overall scalp? For instance, does 10% here mean “10% more than the currently thinning hair on top”, “10% more than the overall follicle count”?

    Admin, you are gentleman and a scholar. Thank you for your tireless work on behalf of us all.

  6. Thank you so much for your work admin!! I check your blog everyday and I must say you are just the best at what you do. In a time where forums are filled with negativity and misinformation, you are just the go to source for accurate, important/interesting, up to date information. I want to wish you the very best, you deserve it!

  7. You cant blame the weather on the weatherman. November december seems to be always when we get all the good news surpressed over the year.

    I’m just wondering if we will even hear a peep out of shiseido. Pretty certain they failed though. Follica. Jak. Those are the last other companies to go for an end of the year report.

  8. Will Tsuji help NW 7’s? Also, if you have severe diffuse thinning can it help with that? If so, how exactly will it fix it?

  9. Great work admin! I still believe 11% is weak for 2018. I’m hoping they can increase that number to 30% with their final product. Like you said it’s definitely a breakthrough if it has no sides and used only 3x a week. However, they are still 4 years away from releasing anything. SM is my best hope for 2020 release. I like their professionalism and quick moving process just like follicum. SM has important political investors so I am 99% sure this will get released first. I’m hoping they can get at least 20% regrowth and thickening of weakening thinner hair. I have a feeling follica is waiting for SM to get approved to use it in their cocktail. I will still root for my boy cots! Haha. We know his treatment wounding works. Too many examples on reddit and that Indian study show its successful. Tsuji will be our cure! The question is how long will it take for us commoners to get it done for our scalps.

  10. Realistically we are still at least 3 years away from any new side effect free treatment and 5-7 years away from a possible cure?

  11. Ron, Trinov just came out this month and is a treatment without side effects. So you are off by 3 years already :-))

    Cure…who knows when and you could be right if Tsuji and Shiseido both fail in 2020.

  12. Here’s the Tsuji Schedule:

    — They began pre-clinical safety testing in animals last July. (Human regenerated hair follicles transplanted into the backs of mice) / They plan to complete the safety testing in 2018.

    — If the results of the safety tests are successful (no toxicity or no malignant tumor formation) they will apply for clinical research to the Certified Committee for Regenerative Medicine (Class II: Medium Risk).

    — After receiving approval they will present a provisional plan to the Minister of Health and shift toward implementation of clinical research (the details of the clinical research will be announced before the initiation of the research—They will start the clinical research with Male AGA patients).

    * They believe this is the novel therapeutic treatment of the 21st Century and could lead to a Japanese Renaissance in Regenerative Medicine.

    ** And all of that will unfold over the course of 2019—making 2019 the most historical year in the history of making hairloss history. : )

    No question marks.

    [source: http://www.organ-technol.co.jp/uploads/2018/06/98a3d5caabf1c7829941ab2d5caf20f8.pdf%5D

  13. As for Follicum:

    —”We expect to start a topical hair study at the earliest in late fall 2019″

    *At the earliest they are a full year away from starting their trial. : (

  14. I have a feeling if SM outperforms follicum and gets released in 2020, follicum will shut their trial down. They are 3 years behind. If they can outperform SM with like 20 to 30% then they can still compete. Not sure why they need a whole year to start another phase 2. They probably know other players are ahead of them and want to see what their results bring by next year this time. This could give them the green or red light to move forward or not.

  15. riken could bankrupt all the slow pokes so their 5 years away claim is irrelevant.

    Anyone got any compelling pictures of trinov because from what I understand it’s c

  16. Agreed, @Toccata all going well, 2019 could be an unprecedented and historic year. Potentially by the end of 2019 RIKEN could provide actual photographic case-study evidence of the comprehensive reversal of baldness in a number of human subjects.

    Imagine that for a moment! It really is a beautiful thought.

    Another beautiful thought. A condition of the preclinical safety tests (that are currently being carried out) was that they must be conducted EXACTLY the same way that the human trials will be in 2019 – so all the methods, materials, packaging, transportation, even procedure manuals are IDENTICAL to how human work in 2019 will be carried out. These preclinical tests are more than giving ol’ mousy a mohawk, they’re a dress-rehearsal / dummy run of the whole process. In effect, it could be said that the treatment actually exists now!

    But ironically, if safety trial leads to clinical trial leads to commercial release in 2020, this is where our collective angst could well ramp up to new levels – we’ll know that the mechanism to alleviate our suffering actually exists, but is out of reach, for god-knows how long.

    I think we can assume that RIKEN has the ability to stably mass produce follicles etc – their press releases wouldn’t be so confident etc – but it’ll be just SO interesting to find out the mechanics and logistics of the practical trial/commercial rollout etc, like how long it would take to graft exponentially more follicles than ever before, what kind of technician training protocols will need to be developed to handle the demand, and how much will be in the hands of the (very limited) pool of experienced HT surgeons and for how long?

    Many question marks. So many.

    And of course, one of the bigger questions: if commercialization comes to pass in Japan in 2020, will non Japanese visitors be eligible for treatment? Bearing in mind that such a fast-tracked commercial release is, to my understanding, conditional on monitoring patients for years…

    It is incredibly exciting to know that something so profoundly game-changing is on the horizon, and if you’ve got time on your side you should be extremely comforted.

    But a 2020 cure is a complex reality.

    Yes, RIKEN are on track to effectively ‘cure’ baldness by then, they may well already have it sorte, and that is cause for excitement and gratitude, but as far as availability and access – all the moving parts required, the infrastructure that needs to be developed, the overwhelming potential local demand, and not to mention any one of 100 small anomalies that could slam the brakes on testing, trials and release, I tell myself to take a breath, be grateful for the progress and hopeful about the future, but realistic enough to know that it’s almost certain that me and the miracle will take longer than ideal to finally reach each other.

  17. Does anyone know if Riken and the other new companies are planning to create new complete follicles in vitro, or are they creating cells that create new follicles after injection into the scalp?? Complete follicles in vitro is a lot safer and is a legit cure, where cancer and direction of hair growth wouldn’t be an issue.

  18. Admin, Did you remove a feature that allowed responding under someone else’s post? Apologies if you’ve spoken of it already.

    1. No, did not even know if that could be done! This WordPress theme does get updated every month, so they may have changed things.

  19. Hi everyone, this is my first time ever posting a comment, so I do apologize if I am not following the correct procedure.

    I’ve been following this forum for several years now, and it seems that we are coming closer than ever to realizing a true cure.

    My highest hopes are still focused on Tsuji and his ability to mass produce new hair follicles, but other companies such as Samumed have received large-scale funding and their progress points to the intent of a 2020-2022 widespread release.

    However, as haironmykeyboard mentioned in his post above, there are a number of complications that exist with the release of a Tsuji cure that perhaps would not exist with a lotion or a pill.

    My question would be when would you expect to see Tsuji’s technology be available to the wider market of consumers (of course this is still a smaller market, as it will likely cost upwards of $15,000 US)?

    Personally I believe that if their trials show success, we will see some of the well-known international HT surgeons get access to this technology where the restrictions are not as stringent as they are in the US. An alternative I could see would also be a migration of HT surgeons into Japan, which would become a kind of Mecca for those seeking to rejuvenate their scalps. I remain optimistic that a stem cell based cure will not be unattainable for a dismayingly long time (hopefully 2022-2023 assuming a 2020 Japan release).

    But I am very interested to hear your opinions on the timeline of both Tsuji’s cure and Samumed/others.

    Cheers everyone :)

  20. @ Jacob
    It is in my opinion the price is going to kill the people who would most benefit from this procedure strictly because of the extent of their hair loss is so advanced. Who really needs hair multiplication? I’d say it’s probably high norwoods nw3 onwards with aggressive hair loss and as a rule I’d say the more hair you’ve lost the more you’ll gain from something like unlimited donor supply. I mean if your just losing your hair or have slight recession do you need to have this procedure probably not for some the things we have now will suffice regular transplant, min, etc.. also you could argue that maybe you would want to wait for most of your hair to fall out or at least to come close to its finish before pursuing something like this so you dont have to continually go in for tranplants but that’s up to the person.

    I cant really tell you the definite price or availability because I dont know whose going to have it first but we can make a conjecture using current tranplant costs now keep in mind current transplants use follicle units which have an average ~2 follicles per unit and Organ Tech will be implanting 1 by 1 follicle germs.

    For our equation we will use a nw7 with aggressive hair loss one of the people who I think would benefit the most from having a way to proliferate donor follicles. Let’s say this person has lost 60% of their hair (the crown is the most densely populated so I’m going with over half and that just for the top). The general heuristic I hear is humans have 100000 follicles on there head but this is a low average people can have up to 150000 especially for blondes who have thin hair shafts but tons of hair. So well start in the middle at 120000 follicles before baldness onset. The average price per graft is $6 around me so I’ll use that.

    So 120000 × .6 = 72,000
    72,000 ÷ 2 = 36,000
    And 36,000 × 6 = $216,000
    Paper or plastic?

  21. Admin, Yes, it used to group conversations, which was obviously helpful for talking with people. It’d be worthwhile trying to get that feature back. I expect you to have complete and total control of such things! haha

  22. @H.

    Very interesting response, I definitely agree that it will be an extremely expensive procedure, at least in the foreseeable future.

    For full NW 6/7 I agree in saying that an estimate in the range of $150,000 – $200,000+ US would be realistic, using current pricing in developed countries.

    However, while those with full hair loss progression may benefit the most, I believe that a large portion of prospective patients will also be in the lower ranges of the NW scale, as we see now for regular FUE or FUT procedures. Combined with maintenance of existing hair using Finasteride and/or Minoxidil, the complete rejuvenation of a hairline would be possible with Tsuji’s technology.

    Personally, I think during the time that cost is going to be a prohibitive factor, there will be few people in the NW 6/7 range who will elect for this procedure, but those in the lower range who are still holding on to their hair with the aid of existing treatments will be more highly incentivized to go after the procedure.

    Pricing wise, in the US and other developed countries these procedures will always be more expensive. That being said, there are international surgeons who are IAHRS certified who charge as little as $1-$2 per graft. A lot of the current difficulty, especially in FUE procedures, is extracting the follicles and maintaining them for grafting, as well as the skill in inserting them of course.

    If the follicle cloning technology is successful, I am optimistic that in developed markets the cost per graft may decrease since they are cultured exponentially from a small sample, even though total cost may increase significantly.

    Treatments apart from Tsuji’s will likely also hit their stride in the next 5 years, and a combination of treatments may well yield incredible results!

    In any case, I remain excited about the future of hair loss treatment :)

  23. @ Jacob
    Could be that lower Japanese norwoods feel more incentive for sure if I was living over there I’d definately go. As for having to traveling overseas and pay accomodations to fill in your hairline why wait without hair? You can get a transplant right now to fill that in. The whole reason everyone is excited about this treatment is because of increased donor supply and with low norwoods they reasonably have that supply right now.

  24. In 2019 we ABSOLUTELY Must have a post on this blog that says, “100% Hair Back Treatment Announced”.

    Absolutely Must happen in 2019.

    All my opinion.

  25. According to Seeking Alpha (SA) Updated yesterday, the phase for AGA with Aclaris regarding the topical is now officially complete. They stated once again however that results still wont be announced till early 2019. I think if it was a pointless outcome they wouldn’t leave us to wait in fairness so I am fairly optimistic in that respect. It should be very early into the year 2019 we hear the result, as we can at least say with certainty the human experimental phase is now over, with only 2 months to go until 2019.

    This should cheer Nasa_rs up. It gives me some excitement. I have also said from the beginning I really believe JAK inhibitors will be the cure, if not a full cure then at least as good as. No one can disregard that we are at last VERY close. The results of other alopecias, and the multiple JAK inhibitor drugs and pathways brought to the surface everyday is fantastic!

    Keep up the good posts Admin!

  26. These topical solutions elicit scepticism in me. Wouldn’t it be better to release additional, potent PRP A-Cell Hair Additives/Growth Stimulants? To some, the aforementioned procedure might be expensive. However, it sure beats having to apply topical solutions to one’s scalp daily. For me, I am too busy trying to eke out a living. Am I the only voice in this or what?

    Does anyone know whether or not HIstogen will be a hair additive/growth stimulant if it is released?

  27. Jason Statham.. Another theory is that they have a dud, but they figure they’ll keep the intrigue and interest of investors for as long as possible. Unfortunately, we just can’t read into anything that they don’t tell us. Sorry to be pessimistic, but I can see reasons for secretive actions, both positive and negative.

  28. One of my biggest concerns about the method developped by Tsuji is the length of the anagen phase of the new hair follicles. Will the new hair be able to grow for at least 2 years before beggining a new growth cycle?

  29. Thanks for the post admin.

    Although I understand why, it is not uncommon for people to base credibility of newly founded r&d companies on the basis of the looks on their websites. I understand why, but it is not really viable nor fair. I work at CERN, and being in marketing I deal with spinoffs and start-ups, and I can assure you that even with lousy website layouts and aesthetics, there is solid research in a lot of new companies. Sitting on the consumer end of the line, we usually believe companies with good ideas want to communicate and spread them, which is not actually the case in newly started r&d companies. There is a LOT more things for these companies to think about than to communicate about the potential product, and a lot of processes behind the scenes that takes crazy amounts of time and money. The world does not work in the way that you have some results and then release a product. It takes a lot of behind-the-scenes-effort to get to that point. So just a kind word of advice to us all: dont judge by websites. The websites are at the end of the line, and the smallest of the problems.

    Cheers all, keep up the spirit.

    // S

    1. Thanks Simon and great points.

      Howevever, besides their website, I have other doubts about btechlaboratories too. They seem to talking about 3D spheroid type hair regeneration technology that numerous scientists with 10 plus years of research have been unable to do…and these guys appear out of the blue and make bold claims on their home page. They say “develops and commercializes high-tech 3D stem cell technology to generate in vitro hair follicles” meaning they are already doing this (present tense statment). So they already have a cure, but no-one has ever heard of them till this past month?

      I also did a company backgroung search on btech and came away with even more skepticism.

  30. From solid sources, I heard that the former lead scientist at Btech Luxembourg was indeed successful in generating hair producing human 3d skin organoids. Short before Btech Luxembourg went bankrupt due to mismanagement.

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