Update From The God Himself - Dr. Takashi Tsuji

[byebyehair]

Research teams cannot predict the future.
They set the most optimistic timeline possible. That's it.
Failing to meet this timeline does not equate total failure. It's just a rather expected postponement, actually.

But you have to admit... So far this Team made quit a good job in terms oft estimation.

And the shorter the time horizon the more accurate is the prediction. And their prediction is horizon is a little less than 2 years now. So i have a hard time beliving they are 4 years wrong and some people here can identify this but not the research Team.

And the japanese people are Mord eager to met the timeline than the Western counterparts

 

[byebyehair]

So One question at all The non-believers here.
When Started The recruiting for Replicel?
When started the trial of Replicel?

Here You Can See The trial:
https://rctportal.niph.go.jp/en/detail?trial_id=UMIN000023343

The Registered date:26/07/2016
So in The Replicel trial The recriutment Phase Wasnt published on The rctportal...

Is there a possibility for not publishing The recruitment Info?

That is what i said AS well... They could have allready started recruitment.

But @Hate da Bt knows for a fact they did not so far. So you musst be wrong^^

 

[RolfLeeBuckler]

This is what i got of Organ Technologies:

This is Organ Technologies.

Thank you very much for your inquiry.

We are conducting research to provide patients with our technology
as you have expected.
The method of recruiting clients and clinical trials or subjects are undecided now.

We hope to confirm our progress on our new HP new arrivals and media etc.

I am sorry to hear that you will respond to your expectations,
but I would be pleased if you can understand it.
We will encourage our employees to use words from you
and we will make every effort to realize it as soon as possible.

 

[alibaba92]

This is what i got of Organ Technologies:

This is Organ Technologies.

Thank you very much for your inquiry.

We are conducting research to provide patients with our technology
as you have expected.
The method of recruiting clients and clinical trials or subjects are undecided now.

We hope to confirm our progress on our new HP new arrivals and media etc.

I am sorry to hear that you will respond to your expectations,
but I would be pleased if you can understand it.
We will encourage our employees to use words from you
and we will make every effort to realize it as soon as possible.

Seems like they use a translator.

Isnt it clear that the recruitment has not commenced yet ?

 

[Hate da Bt]

But you have to admit... So far this Team made quit a good job in terms oft estimation.

And the shorter the time horizon the more accurate is the prediction. And their prediction is horizon is a little less than 2 years now. So i have a hard time beliving they are 4 years wrong and some people here can identify this but not the research Team.

And the japanese people are Mord eager to met the timeline than the Western counterparts

How long have you been in the hair loss fora?
I've been on this board for almost three years.
When the very first paper came out in 2011, it hadn't even crossed my mind I'd be balding.
The announcement of the colab among Riken, Organ Technologies and Kyocera came out when I had just freaked out about going bald (summer 2016).
I was thrilled at first (I wanted reassurance I would not be bald for long) , but reality struck me very soon and I realised that, even if 2020 was the year hair multiplication became a reality, it would take years for it to become affordable and available worldwide. There were even back then pitiful losers like That Guy, who attacked me vehemently, like all losers do per usual (it's their way of battling with frustration, but I've had enough, this b**ch is fighting back!).
Then, the losers admitted indirectly that what I had said from the getgo was damn right.

Don't get me wrong!
I do believe in Organ Germ Technology and, if they succeed, it's game-change for tissue generation, the goal true scientists really care for.
Nonetheless, it was obvious to me their timeline was very optimistic. Up until last week, I hoped that a related announcement would be released, but LeeBuckler posted he received a response from them, which clarified that they hadn't started recruiting yet. He may be crazy, but he wouldn't lie about it, I think.

That is what i said AS well... They could have allready started recruitment.

But @Hate da Bt knows for a fact they did not so far. So you musst be wrong^^

I said, Freund, that up until early February they hadn't started yet. I have NO clue what they did in the meanwhile.

This is what i got of Organ Technologies:

This is Organ Technologies.

Thank you very much for your inquiry.

We are conducting research to provide patients with our technology
as you have expected.
The method of recruiting clients and clinical trials or subjects are undecided now.

We hope to confirm our progress on our new HP new arrivals and media etc.

I am sorry to hear that you will respond to your expectations,
but I would be pleased if you can understand it.
We will encourage our employees to use words from you
and we will make every effort to realize it as soon as possible.

Kannst du nicht auf Englisch lesen?
Es ist ja klar, dass sie keine Anwerbung angefangen haben.

Seems like they use a translator.

Isnt it clear that the recruitment has not commenced yet ?

It couldn't be clearer.

thats true and they were saying 2020 right from the start in 2011 and again last year so it stayed pretty consistent

The timeline was set in 2016 for the first time and they had said they would start clinical trials in 2018.
Guess!

 

[RolfLeeBuckler]

Schedule
Under the plan, we will begin manufacturing samples for preclinical tests in July
2018 and we will conduct preclinical safety tests using animals. We plan to complete the safety testing in 2018. If the results of the preclinical safety tests are successful, we will apply for clinical research to the Certified Special Committee or Certified Committee for Regenerative Medicine. After receiving approval from the Committee, we will present a provisional plan to the Minister of Health, Labor and Welfare, and will shift toward implementation of clinical research. The details of the clinical research will be announced before the initiation of the research.
————
How we Can find out of Organ Technologies has at least applied to The Certified Special commitee for regenerative medicine? Any ideas?? I googled it But didnt find anything. Will do it tomorrow again extensively.

 

[Robert Robertson]

You know, when I was in my teens I really was against wigs, toupees, etc. But that's where the technology in this field has progressed, and as I'm getting older, I'm starting to think more and more that I'm just going to get a hair system.

Does anyone have any experience with these hair systems? Can anyone help me with these questions. Is it obvious that you're wearing it, is it itchy, how often do you take it off, can you put it on yourself or do you need someone to do it for you, how much does it cost, and which brands/retailers do you recommend?

 

[byebyehair]

How long have you been in the hair loss fora?
I've been on this board for almost three years.
When the very first paper came out in 2011, it hadn't even crossed my mind I'd be balding.
The announcement of the colab among Riken, Organ Technologies and Kyocera came out when I had just freaked out about going bald (summer 2016).
I was thrilled at first (I wanted reassurance I would not be bald for long) , but reality struck me very soon and I realised that, even if 2020 was the year hair multiplication became a reality, it would take years for it to become affordable and available worldwide. There were even back then pitiful losers like That Guy, who attacked me vehemently, like all losers do per usual (it's their way of battling with frustration, but I've had enough, this b**ch is fighting back!).
Then, the losers admitted indirectly that what I had said from the getgo was damn right.

Don't get me wrong!
I do believe in Organ Germ Technology and, if they succeed, it's game-change for tissue generation, the goal true scientists really care for.
Nonetheless, it was obvious to me their timeline was very optimistic. Up until last week, I hoped that a related announcement would be released, but LeeBuckler posted he received a response from them, which clarified that they hadn't started recruiting yet. He may be crazy, but he wouldn't lie about it, I think.


I said, Freund, that up until early February they hadn't started yet. I have NO clue what they did in the meanwhile.

Kannst du nicht auf Englisch lesen?
Es ist ja klar, dass sie keine Anwerbung angefangen haben.


It couldn't be clearer.


The timeline was set in 2016 for the first time and they had said they would start clinical trials in 2018.
Guess!

I have been arround since 2016.

So 2016 they predicted 2020. In 2018 they still predicted 2020.
Let us assume the worst... they had in the 2 year period a delay of 11 months. This would still be very good.

They claimed they passed the state of research in 2018.

So here is my interpretation of this statement.
Passed research state -> they allready have the follicles build (what we saw on some pictures) -> they are confident the follicle is fully functional.

They allready showed that they were able to grow human hair on mice a few years back. So there is no indication the pre clinical trail could fail.

They can grow the hair of a specific human x on a mouse -> they have to be able to grow the hair of human x on human x since there should not be an autoimune reaction cause the cells are from human x and we all know hair transplants work.

So from now on this should be smooth sailing with only delays due to regulations. (or a total failure because unknown problems araise which i doubt).

Yes it will be innicially very expensive. But we all knew the cure could eventually get pricy. This is why I focused on my studies with the first signs of balding. I now have a masters degree and finished on the top 10% of my year. I earn enougf money to get my hair back no metter what the cost are.

You can call us delusional loosers but some of us just staied positiv. Beeing almost completly bald at age of 25 i know my youth is lost but I m not giving up on my future. And even if I am totally wrong about the tsuji procedure the faith in the treatment gave me all the reason I needed to make a someone out of me.

Yes after a second read I realized i sound like a religious fanatic but who cares. Tsuji is allready praised as a god.

 

[Dogma]

Friend, YOU speculated that the trial will commence in late 2019-early 2020. I haven't speculated once.
Stop speculating. That is what I object to.

OK now you’re being an idiot, this thread is literally made about the announcement that the human trials should begin in 2019, the mods deleted the article go down a few comments and you can see the quote from the article that is literally what this f*****g thread is I’m not speculating on anything that’s what started this f*****g thread

 

[Dogma]

Mein Freund, wieder?
That's what they said in the latest announcements.

“They” again this mystical they Who is they, it’s just an article it’s certainly not Dr. Tsuji The article literally says “they“ in terms of the head researcher in which all our hopes he has said nothing about commercialization in 2020… Answer the god damn question about who they is or concede that they is just a fill in for the f*****g article

 

[Dogma]

Dude what you wrote may be true for medicine but i think it is different with stem cell based treatments.


You remember replicels first trial? Very high dose... So this proves you are wrong.

Furthermore Tsujis method makes no sense to study in several trials (except for the number of candidates) They can start a trial and continue recruting if it looks good in the beginning. Since they dont need to do a dose ranging investigation the can just contiusly increase the number of participants till the sample size is sufficient for a phase 2 trial. This way they can keep their 2020 prediction.

Don t get me wrong i know there is a lot of speculation from my side here.

But here i stand and have to choose to either believe it is coming 2020. (which is predicted by a higly respected scientist who is backed by giant companies a solid research team and even the japanese government) or believe it is coming out around 2030 (which is predicted by some random guy who used "common sense" i tend to choose the first option.

OK, come on, like really come on what you quoted about a phase 0 is a statement directly from a source about the process of clinical trials HOW DOES ANYTHING ANY LAB DOES PROVE ME AS MYSELF A PERSON THAT DID NOT WRITE THE ARTICLE OR MAKE THE STIPULATIONS OF EVERY PHASE WRONG??? Like really, use your head that is a reliable source that states what most researchers have to go through from the initial testing to the phase 3 of clinical trials, I provided a second source A medical publisher to authenticate the first source this is their statement not mine! The very high dose for replicel was not a phase 0, it was a phase 1 and most importantly their product is autologous!!! Meaning from the patient’s own body! If you think that at least 90% of clinical trials whether pharmaceutical or cellular do not begin with a very low dosage and then increase the dosage afterwards you are delusional you are arguing against two credible medical sources you’re not arguing against my f*****g opinion, you are arguing against the structure of clinical trials which means you might as well be arguing with a brick f*****g wall! There is no me being right or wrong I’m not giving an opinion I am providing a source stating a fact.

Secondly in regards to your initial comment I have already explained multiple times how Japan is one of the only countries to have a separate governing body for pharmaceutical drugs and cellular therapies, I’ve gone over this repeatedly and in depth!

Finally it does not matter how well his research went in the animal models he will still have to do a safety phase 1 in humans seven months minimum ( most of which is patient enrollment, tremendous amounts of data collecting and paperwork as well as just waiting to see what happens with the enrollees, it can be the best most infallible treatment in the world, it should go without saying you still have to enrol patients, collect data and put it all on a lot of paper), he will then have to do a phase 2 in Japan because this is a cellular-based therapy once the safety is again confirmed they can offer The treatment early to the few people that can afford it well they are finalizing the phase 2 and will have to proceed with the phase 3 complete it which takes quite a long time which then leads to full commercialization. Dr. Tsuji said that human trials would start in 2018, they didn’t they ran into problems this thread is about how they overcame that problem and how they are starting in 2019 OK he made a mistake it’s likely to happen again it always does they are working with state of the art technology in unknown waters so to speak. The only Way you are getting this treatment in 2020 is it the phase 1 goes perfectly well, investment is never falters end of phase 2 goes even better to the point where they can begin offering the treatment to a select few which will result in a large waiting list and almost certainly a major mark up, this will give them more money to not only finish the phase 2 but to also complete the phase 3, which despite the fact Japan allows researchers to offer their treatments if they are cellular-based as long as a phase 2 has been confirmed for safety, A phase 3 is still required for full out commercialization.

 

[Dogma]

Their own words are not speculation, loser.
You, people, are so damn pathetic.
I'm already imagining you, specifically, talking sh*t about Tsuji in a month or so.
But they said 2020...
Losers, you never learn. Never, that's why you are at the bottom of the society.

WHO IS THEY!!!!! It certainly was not Tsuji... What I do remember in the interview this fourm conducted years ago he said human trials begin in 2018 indisputably, incontrovertibly they did not they have not started yet even they are to start this year which is how and why this thread was created that was the announcement!

 

[Dogma]

Research teams cannot predict the future.
They set the most optimistic timeline possible. That's it.
Failing to meet this timeline does not equate total failure. It's just a rather expected postponement, actually.

Jesus Christ, where did that come from a logical response… You know that is called a prediction, get the headlines flowing. Just like how they said and by they I mean the CEO of Organ technologies/ Dr. Tsuji in an interview done on this website human trials that start in 2018 and they did not! You’re damn right they can’t predict the future, but all you’ve been going on about is how they said 2020, they said 2020, they said! Here’s the speculation just like their 2018 projection for human trials which they also used to justify that they were on track for a 2020 release fail, this will not reach for commercialization in 2020 guaranteed I bet my house on it, best case they complete phase 2 which means a very early access to a select few because of the new regulations in Japan in regards to cellular therapy.

So best case scenario you better be in Japan or better yet be Japanese, have a lot of money and or have some connections with organ technologies

 

[H]

Jesus Christ, where did that come from a logical response… You know that is called a prediction, get the headlines flowing. Just like how they said and by they I mean the CEO of Organ technologies/ Dr. Tsuji in an interview done on this website human trials that start in 2018 and they did not! You’re damn right they can’t predict the future, but all you’ve been going on about is how they said 2020, they said 2020, they said! Here’s the speculation just like their 2018 projection for human trials which they also used to justify that they were on track for a 2020 release fail, this will not reach for commercialization in 2020 guaranteed I bet my house on it, best case they complete phase 2 which means a very early access to a select few because of the new regulations in Japan in regards to cellular therapy.

What kind of house you got?

 

[Dogma]

What kind of house you got?

$350,000 worth three floors including basement, even with Japan’s new regulations on cellular therapy it is not mathematically possible for them to do a full commercialization which requires all three phases of a clinical trial to be completed. If phase 2 safety side is complete yes they can release the product to the people who can afford it and based on the supply they have to meet the unquestionably high demand that will follow, that is not full commercialization That is the only hope for 2020, and even that is a stretch

 

[Dogma]

smart move. release to people who can't afford it-also I don't think there will be high demand if it's very expensive. you all overestimate how many rich people of young age would spend hundreds of thousands for hair. especially because rich guys are mostly old as f***. I would assume only a handful of people would be interested in this right of the bat. I still think for the average dude from the US, this is around 8-9 years away minimum

My apologies that was a voice dictation error, I meant to say they will offer it to people that can afford it, I don’t believe it would be hundreds of thousands around 10 that is 100% speculative but organ technologies has expressed that they want to make this treatment affordable… However they are referring to when it is actually fully released which even in Japan requires a phase 3 which takes years. During the early conditional release after a phase 2 safety confirmation that’s not going to be cheap.

 

[Dogma]

What’s so funny is when I first commented one of the first people to blast me was someone mocking me for thinking that anyone on this website was stupid enough to think that they would actually have a full commercial release by 2020, I explained to him that this place is rife with people that believe that, I’m not gonna bother going through to find him But I hope he has taken a look to see what is blatantly obvious and how right I was.

 

[Dogma]

Schedule
Under the plan, we will begin manufacturing samples for preclinical tests in July
2018 and we will conduct preclinical safety tests using animals. We plan to complete the safety testing in 2018. If the results of the preclinical safety tests are successful, we will apply for clinical research to the Certified Special Committee or Certified Committee for Regenerative Medicine. After receiving approval from the Committee, we will present a provisional plan to the Minister of Health, Labor and Welfare, and will shift toward implementation of clinical research. The details of the clinical research will be announced before the initiation of the research.
————
How we Can find out of Organ Technologies has at least applied to The Certified Special commitee for regenerative medicine? Any ideas?? I googled it But didnt find anything. Will do it tomorrow again extensively.

They did not complete the safety testing in humans in 2018 like they planned, they ran into “hurdles” Which apparently they overcame and are now ready to begin human trials this year which is what started this thread

 

[Trouse]

Before 2025: CB-03-01, maybe Follica (the first version of it with only minoxidil )
2027 - 2030: Maybe Tsuji.

That's my prediction. Anything else is bullshit. If some x treatment will come out, kudos, but I'm not going to make any predictions that at the end of the day is just wishful thinking. Been battling hairloss since 2011, so I've seen some sh*t.

I just don’t understand what could possibly be taking Follica so long. If their approach is equal parts micro wounding and patented topical treatments (and that’s being generous, since we have no idea if they’re even developing propriety topicals) then why don’t they just roll them out in separate phases? I have come to terms with how painstakingly long it takes a novel drug to reach the market, but a wounding method?

How much fine tuning can there possibly be? Either their theory was grounded in sound science or it wasn’t. Either their trials demonstrated legitimate progress or they didn’t. The continued delays and deafening silence are maddening. I mean really, what they are waiting for - a 25 year follow up study or something? Jesus.

 

[soull]

I do not understand anything about medicine or anythingrelated, but what I want is that in the 2020 communicate thatthis method is effective. If it marketed years later, it's anotherstory.