Update From The God Himself - Dr. Takashi Tsuji

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Iah11

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Chocolate Lebron said:
Does anyone know “ball park figure” how much this treatment will be ?? Or is it a continued treatment ?
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It will be massively expensive at first. For me, it would just be great to know that there actually is a treatment out there, an actual cure.
 
MrV88

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Iah11 said:
From my understanding, certain treatments (cell based therapy?) only need one trial before going to market. There must be conditions, I'm not sure though.
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After 263527 pages and a lot of crap I don't really remember the Japanese easy going laws for this type of treatment, but it shouldn't be far away after they start their human trials, so the point is to start it
 
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Dimmer97

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How long do clinical trials take to complete? Do clinical trials in Japan have several steps?
 
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Iah11

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Recently, last year, a therapy named Stemirac was approved for use in Japan following a phase 1 trial in Japan on just 13 patients. The catch is that the phase 1 lasted 5 years, I believe because scientists are cautious about cancer risk, understandably.

The Japanese law is very liberal in the sense that it takes literally one trial for conditional approval. The next 7 years are deemed a phase 2 of sorts, because in these years the company still has to provide evidence of safety and efficacy, even though the product is for sale.
 
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byebyehair

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Dimmer97 said:
How long do clinical trials take to complete? Do clinical trials in Japan have several steps?
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upload_2019-3-10_22-23-37.png

tsuji aims for the right one.

Speed and Efficiency
The concept behind the conditional approval pathway is that a product can be approved based on data confirming safety and predict efficacy and the pivotal confirmatory trial(s) are allowed to occur after the product is marketed and made available to patients in Japan. This is shown graphically in Figure 2. Via the conventional approach, one or more pivotal registration studies were needed before making an application for marketing authorization. In the new approach, a conditional marketing authorization may be granted based on a single, small-scale trial. Once more, the sponsor can market the product while performing one or more confirmatory studies. The duration of time between initial conditional approval and reapplication can be as long as seven years, although this period may be shorter as determined by Japanese regulators.
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https://www.caladrius.com/wp-content/uploads/2018/05/Sietsema-et-al.-2018-RAPS.pdf


So yes a single trial can be enough. There is a conditional release for a spinal injoury treatment granted that only was tested on 13 person. Please keep that in mind when someone is trying to calculate a possible release date.

The following holds true for tsujis treatment:
- Efficiancy can be evaluated after less than 3 months. The new hair in mice started to break through the skin surface in less than 3 weeks.
- Human hair were produced in the mouse trial. (To my understanding the only dangerous side effect that could occure with this treatment is uncontrolled growth of the cells that turns to tumorgenesis. Since that did not happen in mouse it is save to assume it wont happen in human.)

If they start trials in january 2020 they could be finished by april and launch the product in summer 2020.
(This is just an example. Nobody knows when it will be out but please relax. The people on here "calcualting" when the treatment can be out soonest are talking out of their asses without having read the regulations. Because they don t need facts they have gut feeling!)
 
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Dimmer97

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So basically, us that are not from japan have to wait until it has been re approved? So basically wont become available to the public within 7 years?
 
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Joxy

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What I only care is that they have something that actually works. 1-2 years later it doesn’t matter to me.
 
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byebyehair

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petersonKj said:
don't they need more time to asses whether the hair cycles are functioning properly? the actual thing is, multiple trials simply do not make sense since you don't need dose ranging trials(what for) and safety+efficiency can be evaluated immediately. unlike RCH-01 it either works or the body won't accept the hair and it doesn't work. however the question is, during that initial marketing period after the first trial, will it be available for us foreign folks, I think I read somewhere during that period only nationals can get access to the treatment? because if not, THEN we need to wait for the second period for 7 f*****g years which would be completely awful. but also not very smart of the japanese government to only make it available to nationals right? so does anybody know of that policy? if everything goes well this could very well be available by 2022 if we are lucky and actually are allowed to go as foreigners
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The 7 years is the longest period of time possible for the data gathering of the conditional release. It may be 3 years til they go for a complet release.
The duration of time between initial conditional approval and reapplication can be as long as seven years, although this period may be shorter as determined by Japanese regulators.
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So stop taking this 7 years as a fixed value.

And the regulatories don t specifiy the treatment is only available for locals. Maybe it is sufficient if they gather data from locals and still give the treatment to foreigners without monitoring. Who knows.
A conditional approval will be time-bounded and include requirements for further studying the safety and efficacy of the regenerative medical product during the conditional approval period.
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Why not start clinical trials? Is there a reason they wouldnt want to start for that long?
 
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Iah11

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Worth noting that all the other therapies that have come out on conditional release have been in the region of $100,000. I don't know how pricing would work for this because surely it would be done based on the amount of hair cloned.
 
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Iah11 said:
Worth noting that all the other therapies that have come out on conditional release have been in the region of $100,000. I don't know how pricing would work for this because surely it would be done based on the amount of hair cloned.
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You have a list of conditional releases from Japan with prices?
 
MrV88

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petersonKj said:
why does that law not specify whether it is only for nationals or not..
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Why should it? Would be completely dumb... This law is for getting those treatments ready much faster than any other country, for technological advancement and earning a shitload of money for Japan, so think about it again if it would be limited just to them..
 
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glammetal

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Besides the reasons that were posted,Implication of law is a matter of national territory by a large extent and not a matter of ethnicity or citizenship in western - democratic countries such as Japan
 
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H

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Why wait a year until 2020 to start human trials? I suppose to keep an eye on the mice just in case or maybe gives them more time to get ready but I would think if they got approved they'd have every incentive to keep the momentum going...
 
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