Tissuse Smart Hair Transplants Shares Technology With Japanese Company

MeDK

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1. Obviously the timeframe. If like @Fuji Maru Kagurazaka said they are starting their trails by the end of the year how much will the trials last?

You can't predict that well what the future holds, are there problems or not?

2. How many phases?

If you want to release something, then its at least phase III for EU, Japan have their Phase II exception

for instance the Phase III

Phase IIIa: Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase IIIa clinical trials generate additional data on both safety and efficacy in relatively large numbers of patients in both controlled and uncontrolled trials. Clinical trials are also conducted in special groups of patients (e.g., renal failure patients) , or under special conditions dictated by the nature of the medicine and disease. These trials often provide much of the information needed for the package insert and labeling of the medicine. Phase IIIb: Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine's approval and launch. These trials may supplement earlier trials, complete earlier trials, or may be directed toward new types of trials (e.g., quality of life, marketing) or Phase IV evaluations. This is the period between submission and approval of a regulatory dossier for marketing authorization.

3. Can they give a ballpark estimate when they could push it to the market?

Same answer as the first, its hard to predict the future.

The question at most seems pretty weird, when you think about the timeframe there have been with other trails.

Can you predict a price 5 years into the future? with inflation taken into account and what not.

Its fine that people want to send question to researchers, but they should at least be relevant to present time and near future and not questions that are years away.
 

MeDK

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i don't think the trail 3 thing applies to autologous cell therapies does it

According to Replicel is does. Just to quote them.

When will the RCH-01 treatment for pattern baldness be available on the market?
In short, we are not yet in a position to adequately predict this. RepliCel recently completed phase 1 human clinical trials of all its products currently in development, including RCH-01. In most countries, it takes completing at least three phases of clinical trials to obtain approval to market a product.

Japan has recently created rules by which certain cell therapies may be commercially launched much faster than is the case in most countries. This has fueled speculation that RCH-01 may be put on the market after the current trial being conducted in Japan is completed sometime in 2018. While this is a possibility there is not guarantee this will happen for a host of reasons. Stay tuned!
 

MrV88

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Dear Mr. ,



We received answer from Japan.

Due to the unexpectedly high international interest in the project, the team is currently unable to answer individual queries.

However, several statements are planned for the media.

Unfortunately we can only recommend you to wait for news on the internet.



We are very sorry that we do not have a satisfactory answer for you at this point. Unfortunately, as we said here, the hands are tied, because we are in the cooperation only advisory activities.



Best regards,

The TissUse team

(Google translate)

And I've waited a month for this lol...
 

RolfLeeBuckler

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Hello! I am Fuji Maru Kagurazaka.
I live in Tokyo, Japan. Thank you.

Because it is a personal communication, everything can not be published.

J. Hewitt, who started clinical trials in Japan early on, had transactions with many beauty clinics in Japan and was likely to be conducted with them.

This contract has obtained development and marketing rights in Japan, and J. Hewitt takes the initiative in Japan.

Already in Japan "Kerastem Hair Therapy" has been launched, and TissUse SHT (Smart Hair Transplants) may be launched earlier than any region of the world.

https://www.mouhatsu-saisei.com/male/kerastem/

May God bless your scalp!

View attachment 118216

can you please contact J Hewitt, Jon Knight and ask him when he will start the trials?
 

werefckd

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Tissuse unfortunately deleted the info site about SMT Smart Hair transplant :(


I have already contacted Tissuse. They restructure their website this is why the info is deleted temporary.
No reason to worry my friend ;)

And 1 year and a half later the info about SMT still hasn't come back. So much for "deleted temporary". Weird that it looks like they don't want to be even linked with the technology.
 
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werefckd

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Ok summing things up about Tissuse and "Smart Hair Transplants" - just the facts:

- The Tissuse research never advanced past the in vitro phase
- No pre clinical studies with animals were ever done
- They ***believe*** they have enough data from their in vitro research to start clinical trials in Japan
- We don't know if Japan has actually gave them a formal permission to start clinical trials (or if it's necessary)
- Tissuse "licensed" (or gave) the SHT technology to J Hewitt and it's up to them now to start clinical trials and do further research
- Tissuse said they're basically done with SHT, even deleted any mentions of it from their website.
- J Hewitt promised 1.5 years ago to launch a 5 person clinical trial in Japan
- Nothing has happened since then. The reasons for not being able to start human trials according to J Hewitt are very conspiracy-like: labs are trying to copy/steal their technology and there is one big competitor (Replicel) making efforts to muscle they out.

lol
:-(
 
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werefckd

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just shut up. If you don't believe in it, it's ok. But don't be annoying all the time. Just wait.
We can't do anything else anyway.

tissuse does not ask for money, they are not on the stock exchange.
We have nothing to do with them.

For my part, I have great confidence in them. Due to the current corona pandemic, the delay is completely normal.

but there is no point in discussing it now. Just keep your feet still and wait.
sorry if the facts make you mad but it is what it is
 

werefckd

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We never wrote that we gave up on the technology. It’s just not part of our main business at TissUse. For our main business we are indeed very successfully using the in vitro microfollicle model which is based on the smart hair transplants to assess effects of hair growth promoting/reducing agents for our clients.

In addition we used microfollicles and integrated them into skin models to advance preclinical testing of new substances.



So we are indeed using our hair model for our core business which is in vitro testing. We are not a company which is focussed on the development of cell based therapies. That’s why this part has to be licensed out and further developed by partners.

Indeed if you look at our website you’ll see that we list the hair follicle as one of our models: https://www.tissuse.com/en/technology/

We do not mention the SHT specifically because we got flooded by requests about information which distracts from the main business and were we frankly just did not have the time to answer them all.

For the trials we will of course transfer our know-how to J.Hewitt and a laboratory of their choice. We’ll of course also advice on potential improvements should the need arise.
Ha I think it's funny that they are giving such detailed answers to e-mails from randos on the internet. Good job Jan. We found a lot of new info about them (like the fact that they never tested their tech in a living animal). I think now it's time to get some clarification and updates from J Hewwit like RofllEeBuckler asked.

 

werefckd

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I don't understand how someone could get "they gave up" from they licensed the technology to someone.
not giving up, but Jan posted (and later deleted) and e-mail from them where they state that they are not interested in investing more time in the tech and all future research would be done by the company that licensed it.

Jan why did you delete the posts? did they asked you to do so?
 
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werefckd

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It said: "The SHT technology is not our main business so we as a company are not focusing on further development. This has to be done by external partners like J.Hewitt."

There's nothing negative about that, it's not giving up. We just need to be patient and wait until J Hewitt begins and completes the trial. It won't take long once they begin.

Nobody said they were giving up.

Ok summing things up about Tissuse and "Smart Hair Transplants" - just the facts:

- The Tissuse research never advanced past the in vitro phase
- No pre clinical studies with animals were ever done
- They ***believe*** they have enough data from their in vitro research to start clinical trials in Japan
- We don't know if Japan has actually gave them a formal permission to start clinical trials (or if it's necessary)
- Tissuse "licensed" (or gave) the SHT technology to J Hewitt and it's up to them now to start clinical trials and do further research
- Tissuse said they're basically done with SHT, even deleted any mentions of it from their website.
- J Hewitt promised 1.5 years ago to launch a 5 person clinical trial in Japan
- Nothing has happened since then. The reasons for not being able to start human trials according to J Hewitt are very conspiracy-like: labs are trying to copy/steal their technology and there is one big competitor (Replicel) making efforts to muscle they out.

lol
:-(
Please tell me if that list is not right, and if it is sounding promising as of now for you.
 
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