New Press Release From Organ Technologies

[H]

Not that much actually, it may even be more tricky.

http://www.cdb.riken.jp/org/en/research/organ/hair.html

Same goes for the tooth primordium he created, fully functionnal germ tooth, but after implantation emerging tooth was 50% smaller than usual.

Im sure they'll make sure they grow to full length first lol and germs will be considerably smaller than units with an average of 3 fully matured follicles. They also dont have to transport the supporting skin along with the follicle.

 

[razzmatazz91]

So if I'm getting this right:

• There is no new information

• Despite that, people are freaking out about prices.

• Dick-measuring contest

That's about it.

Sounds about right.
The only new info is that a per-clinical study will have to be done before the human trials next year.

 

[razzmatazz91]

My bullshit meter is going off the chart at those claiming a possible 2020 release. There is absolutely no way that a trial on men in 2019 will follow up with a commercial release in as little as a year. It's a medical procedure that will have to pass the regulatory body of the Ministry of Health just like other therapies. Shiseido trial for rch-01 started nearly 3 years ago and that was phase 2 clinical trial. This hasn't even started phase 1 clinical trials in humans.

I think it was @Hate da Bt who said that in the case of Tsuji, only one trial is needed for safety as well as efficacy. So, in effect, Phase 1 and 2 are the same trial and it will be followed by a confitional release in 2020.

 

[H]

I'm skeptical because only a 1 year window between trial and commercial release seems to ignore the chance of observing participants for possible long term side effects and complications before approval. It just seems way to good to be true seeing how things go in the Hair loss world.

I have also wondered how that gives them enough time to check for tumorigenesis and other such complications?

 

[DanielDüsentrieb]

I'm skeptical because only a 1 year window between trial and commercial release seems to ignore the chance of observing participants for possible long term side effects and complications before approval. It just seems way to good to be true seeing how things go in the Hair loss world.

They can start the trial january 2019 and release it december 2020. That is almost 2 years.

The following is an assumption:

If the follicle germs behave abnormal and start a tumorigenesis this should happen soon after implantation because the mutation which led to this abnormality happened during the replication outside the body. If there weren t any mutations during the replication process, i see no reason why the germs should mutate inside your head and start an abnormal behavior years after implantation.

Can someone with more understanding of these kind of processes give his thoughts about that?

 

[razzmatazz91]

Yeah, @kawnshawn I share your scepticism regarding all this. 2020 does seem too good to be true. But even if it’s 2021 or 2022, it’s still a win.

Can someone with more understanding of these kind of processes give his thoughts about that?

So ppl on an Internet forum are going to be doing a deep research? I’d like to see someone talk sense about this.

 

[Hate da Bt]

I think it was @Hate da Bt who said that in the case of Tsuji, only one trial is needed for safety as well as efficacy. So, in effect, Phase 1 and 2 are the same trial and it will be followed by a confitional release in 2020.

Yep, it was me.
Phase I trials are conducted in order to evaluate a treatment's safety, whereas phase II trials are conducted in order to evaluate its efficacy.
In Tsuji's case, separate phase I and II trials are redundant, as the end result is hair neogenesis, which can be evaluated even in a phase I trial. I mean, either hair follicles sprout or they don't.
It's not like RCH-01 trials, where very high doses were injected in phase I, so that safety could be evaluated, and, then, different dosages were involved in Shiseido's phase II, whereby its efficacy should be evaluated.
According to the trio's plan, conditional release could be achieved by late 2020 at best.

 

[Hate da Bt]

They can start the trial january 2019 and release it december 2020. That is almost 2 years.

The following is an assumption:

If the follicle germs behave abnormal and start a tumorigenesis this should happen soon after implantation because the mutation which led to this abnormality happened during the replication outside the body. If there weren t any mutations during the replication process, i see no reason why the germs should mutate inside your head and start an abnormal behavior years after implantation.

Can someone with more understanding of these kind of processes give his thoughts about that?

That's the exact reasoning behind phase I trials.
Keep in mind, people, that phase I trials rarely last more than two years.

 

[Btg]

still waiting for people whose friend's friend knows an associate of tsuji and will give a release date

 

[The last of the follicles]

still waiting for people whose friend's friend knows an associate of tsuji and will give a release date

Doesn’t matter. This is the only plan that is going to work because it is tied to transplant field. So no market goes out, instead they work synergistically and that alone is enough to tell you it’s going to succeed. Price will be hefty but that’s what money is for. To fulfill our dreams.

 

[Btg]

Doesn’t matter. This is the only plan that is going to work because it is tied to transplant field. So no market goes out, instead they work synergistically and that alone is enough to tell you it’s going to succeed. Price will be hefty but that’s what money is for. To fulfill our dreams.

never said it is not going to work , it actually is a really smart solution to the hairloss problem as it doesnt require understanding of the hairloss process . It wont be the only thing that is going to work ,for sure , but maybe the only thing that is going to work for our generation (if they are successful in their trial )

 

[hairloss_user]

Maybe I have missed something, but why are they doing trials on mice again? Haven't they already done that in the past?

 

[Hate da Bt]

Maybe I have missed something, but why are they doing trials on mice again? Haven't they already done that in the past?

Animal testing, aka preclinical trials, constitutes a prerequisite for the clinical trial's inception.

 

[IncognitoMan]

I have to be honest, if someone guaranteed me this would be out in 5-7 years, that would give me so much hope! Anything sooner would be a dream come true. I am seriously going to start trying to save $15k/year for this.

I do have a couple of questions, which may have been answered but I didn’t fully understand. Do we think we could achieve natural density, or will this be similar to current hair transplant procedures but with unlimited donor hair? From what I gathered from you all, the implanted hair germs could achieve natural density and be immune to DHT. If hair growth direction is truly figured out, this would literally be amazing.

 

[The last of the follicles]

never said it is not going to work , it actually is a really smart solution to the hairloss problem as it doesnt require understanding of the hairloss process . It wont be the only thing that is going to work ,for sure , but maybe the only thing that is going to work for our generation (if they are successful in their trial )

Yes forgive me I said it in a confusing way. I meant to say that the “when” matters little when for the first time ever, a true cure is on its way. And it doesn’t matter when for two more reasons: a. Because now it doesn’t matter what Norwood you are and if your donor isn’t the greatest and b. The price is going to be a big one so having more time to prepare financially is a plus. On that thing you mentioned now, I agree with you that it isn’t set in stone to work. But you know how it goes. Once it starts somewhere, others pop up with similar and improved solution, there is competition after all. The only downside is the people who preach about antiandrogens and castration “solutions”. Those need to die no matter how effective one may think them to be.

 

[BalderBaldyBald]

Yes forgive me I said it in a confusing way. I meant to say that the “when” matters little when for the first time ever, a true cure is on its way. And it doesn’t matter when for two more reasons: a. Because now it doesn’t matter what Norwood you are and if your donor isn’t the greatest and b. The price is going to be a big one so having more time to prepare financially is a plus. On that thing you mentioned now, I agree with you that it isn’t set in stone to work. But you know how it goes. Once it starts somewhere, others pop up with similar and improved solution, there is competition after all. The only downside is the people who preach about antiandrogens and castration “solutions”. Those need to die no matter how effective one may think them to be.

Lel, you still don't get it, we need another maintenance solution and that i agree, antiandrogens are sh*t, always have been.

But a Norwood 3-4 who undergo Tsuji to fill his loss, WILL STILL NEED A MAINTENANCE TREATMENT, for the fourth time, Tsuji will not immunize your remaining hair, how is it so complicated to understand ? price for a NW7 back to NW0 will obviously be ridiculous and cosmetic result will look like sh*t, no matter how gifted your surgeon is.

 

[DanielDüsentrieb]

Lel, you still don't get it, we need another maintenance solution and that i agree, antiandrogens are sh*t, always have been.

But a Norwood 3-4 who undergo Tsuji to fill his loss, WILL STILL NEED A MAINTENANCE TREATMENT, for the fourth time, Tsuji will not immunize your remaining hair, how is it so complicated to understand ? price for a NW7 back to NW0 will obviously be ridiculous and cosmetic result will look like sh*t, no matter how gifted your surgeon is.

Isn t rch-01 supposed to make your hair imune to dht?

So if both technics work the way they should it is game over for antiandrogens.

 

[DanielDüsentrieb]

Maybe I have missed something, but why are they doing trials on mice again? Haven't they already done that in the past?

Since then they changed some parts in the cell replication process. That is the reason why they have to show safety in animal again.

 

[BalderBaldyBald]

Im sure they'll make sure they grow to full length first lol and germs will be considerably smaller than units with an average of 3 fully matured follicles. They also dont have to transport the supporting skin along with the follicle.

Actually this is what i'm afraid of, surgeons already struggle to implant large units correctly, so with germs (or grown primordiums), smaller and harder to handle + that nylon fiber...we will see with first human trials.

Isn t rch-01 supposed to make your hair imune to dht?

So if both technics work the way they should it is game over for antiandrogens.

Finally a relevant comment, thank you

 

[Hate da Bt]

Isn t rch-01 supposed to make your hair imune to dht?

So if both technics work the way they should it is game over for antiandrogens.

I strongly believe that the injection of mesenchymal and epithelial stem cells will prove to be even more effective than RCH-01.