Update From The God Himself - Dr. Takashi Tsuji

[werefckd]

If they are worried about anyone beating them it's Tissuse, but of course you think they failed too

If you are the kind of guy that thinks that taking 10 years to release a treatment consisting of minoxidil and micro needling is not a failure then you may think J Hewitt's failed adventures into hair cloning are a huge success too. I don't mind.

 

[FollicleGuardian]

Isn’t there an accelerated pathway for regenerative medicine in Japan? Can anyone explain that?

 

[sevenseers]

please don't expect too much. I think Riken will only announce start of clinical studies.

which would be incredible no? I just checked i joined this fkin forum in 2013. thinking FOR SURE by 2020 i'd have better options available and can put this sh*t behind me. I am really excited to hear what they say

 

[sevenseers]

Isn’t there an accelerated pathway for regenerative medicine in Japan? Can anyone explain that?

thers a few good posts about this on folliclethought and hairlosscure2020.... I think the gist of it is if they are using cells from the patient's own body then they just need to go through 2 clinical trials rather than 3 before release, and then a third trial can be done as the product is marketed

 

[FollicleGuardian]

thers a few good posts about this on folliclethought and hairlosscure2020.... I think the gist of it is if they are using cells from the patient's own body then they just need to go through 2 clinical trials rather than 3 before release, and then a third trial can be done as the product is marketed

That’s amazing. Thanks.

 

[sevenseers]

That’s amazing. Thanks.

Japan's New Laws to Fast Track Stem Cell Therapies | Hair Loss Cure 2020

In 2013, Japan's parliament passed two groundbreaking laws that aim to speed up the approval process for regenerative medicine involving stem cells.

www.hairlosscure2020.com

The first item linked in the post there explains it pretty well. the criticisms of the fast track at the end of the article are also pretty interesting imo

 

[czecha]

growing hair is one thing, keeping it another, though. the norwood reaper won't be defeated easily

 

[Pls_NW-1]

Yeah, follicle has not the same sensitivity as the follicles which are not affected by androgenetic alopecia, this stuff will give you just the lost hair back, but you gotta maintain it with fina or AA's.

 

[jan_miezda]

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On their website, why do they have a 2018 milestone listed under the 2021 news headline? I think the message will be referring to outcomes of preclinical studies and that they are now planning to enter phase 1 like other say

 

[pegasus2]

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On their website, why do they have a 2018 milestone listed under the 2021 news headline? I think the message will be referring to outcomes of preclinical studies and that they are now planning to enter phase 1 like other say

Probably, but if they start phase I trial now this could be available late next year.

 

[GotHair?]

Japan's New Laws to Fast Track Stem Cell Therapies | Hair Loss Cure 2020

In 2013, Japan's parliament passed two groundbreaking laws that aim to speed up the approval process for regenerative medicine involving stem cells.

www.hairlosscure2020.com

The first item linked in the post there explains it pretty well. the criticisms of the fast track at the end of the article are also pretty interesting imo

Under the Pharmaceutical Affairs Law as it currently stands, regenerative therapies, like small-molecule drugs, must undergo three phases of costly and cumbersome clinical trials to get approval by Japan’s Pharmaceutical and Medical Devices Agency. The proposed amendments to the pharmaceutical law will create a new, separate approval channel for regenerative medicine. Rather than using phased clinical trials, companies will have to demonstrate efficacy in pilot studies of as few as ten patients in one study, if the change is dramatic enough, or a few hundred when improvement is more marginal. According to Toshio Miyata, deputy director of the Evaluation and Licensing Division at the Pharmaceutical and Food Safety Bureau in Tokyo, if efficacy can be “surmised,” the treatment will be approved for marketing. At that stage, the treatment could be approved for commercial use and, crucially for such expensive treatments, for national insurance coverage.

Basically if they show massive effectiveness in as few as dozen patients they could be out on the market in less than 3 years. Unless they have changed the law. The criticisms are also valid. But at least with hair we will now the outcomes easily.

Yeah, follicle has not the same sensitivity as the follicles which are not affected by androgenetic alopecia, this stuff will give you just the lost hair back, but you gotta maintain it with fina or AA's.

This is true. Although the more costly route would be to continuously top it up. That depends on the rate of loss. My started to get noticeable a year and a half after I first noticed it. So if you add some more cloned follicles every 18 months...
Although this is probably not feasible because there is probably a limit on how many hair follicles on scalp you supply through vascular means. Just thinking out loud.
However this should be possible to solve with better topicals coming to market?

I too am hopeful that this is probably an announcement of when the clinical trials will start. Lets hope it is before 2022.

 

[werefckd]

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On their website, why do they have a 2018 milestone listed under the 2021 news headline? I think the message will be referring to outcomes of preclinical studies and that they are now planning to enter phase 1 like other say

This would be awesome but there is a hole in that theory.

If it's true that they just completed pre clinical studies, then it would mean that these studies were running and running fine for the past year.

If that was the case, after Tsuji left Organ he could easily have said something along the lines of "I'm leaving but pre clinical studies are still ongoing via Riken" instead of going radio silent, avoiding the issue and letting speculation run wild. This is a big part of the story that wouldn't make sense.

IMO it's much more likely that what really happened is that the folks at Riken suffered a set back and needed a fresh start with a new research strategy after whatever problem they encountered at Organ. And this would NOT put them close to starting clinical trials now, unless they are aiming to cut a lot of corners - which of course I wouldn't have any problems with.

But even in that scenario it would still be good news as already said before. I think Tsuji and his team have built huge body of knowledge about hair regeneration during the last decade and it would be a shame if it was lost or left unused after the project at Organ failed. So I'm happy that they are still trying.

If they surprise the world and disclose that they are already doing pre clinical studies with large animals or even that they are ready to test the stuff in humans I would be GREATELY and HAPPILY surprised. If they announce that they have already cloned a hair in a human like Pegasus said it will be totally nuts.

What I think what is realistic is that they started a new line of research during the last months that got some success with mice (with iPS cells) and now want to hype it to attract partners/investors and move forward with the research.

But that's all speculation. Let's see what Wednesday is reserving for us.

 

[Tom4362]

 

[pegasus2]

Hair is such a small part of their research, and of course the research would continue. It went without saying to any rational person. Should he also inform you when he goes on vacation that the work will continue while he is gone? He has no obligation to inform deranged baldies about every aspect of their reorganization. The narcissism runs high on this forum, but what's to be expected on a forum that revolves around outward appearance.

 

[werefckd]

It's funny that the person that now is rambling about narcism and stuff once claimed here to have an IQ bigger than Einsten's, LOL

 

[pegasus2]

It's funny that the person that now is blabbing about narcism once claimed to have an IQ bigger than Einsten's here, LOL

I've never said that, but my IQ is in his range, more than 3 SD above the norm, and I'm also better looking than you. Still, I don't think I'm so important that Tsuji owes me anything.

 

[werefckd]

I've never said that, but my IQ is in his range, more than 3 S.D. above the norm, and I'm also better looking than you. Still, I don't think I'm so important that Tsuji owes me anything.

Lol, you are literally the type of person that tries to win internet arguments claiming to have the same intelligence of Einstein and other sh*t like "I'm better looking than you" in a freaking hair loss, anon posting, internet forum LOLOL.

That's a totally new level of pathetic

 

[werefckd]

but he's right. Why should Tsuji give us an update.

In case you didn't notice, they just created a twitter profile to do exactly that.

 

[werefckd]

I mean that with Organ Technologies. He will now publish the interim results. Probably several animal experiments with different species, etc. Maybe even small human experiments

Looking at the freaking Organ website now, (which is a company that Tsuji was involved with), and tell me if that looks like a professional way to go.

 

[pegasus2]

Lol, you are literally the type of person that tries to win internet arguments claiming to have the same intelligence of Einstein and and other sh*t like "I'm better looking than you" in a freaking hair loss, anon posting, internet forum LOLOL.

Most pathetic thing ever.

It's cute that you think I really care about winning this argument with you lol I don't even know what "winning" would like. I'm just having fun messing with you. As to your claim of me being narcissistic, I have admitted on here before that I can be narcissistic too. I really shouldn't care about my hair, but I do. At least I'm self-aware, and not so narcissistic that I think I'm so important Dr. Tsuji has to tell me what he had for breakfast.