Dr. Tsuji Kyocera, Riken Research, Organ Technologies Form Regenerative Hair Research Team

[Xaser94]

I think it means clinical research ends in 2019, which means maybe theyll start in 2017 which means theres two years to to finish the trial, and by 2020 theyll start rolling it out into commercialization. Though this is me making an assumption. I thought what makes this treatment interesting is that unlimited follicles can be derived from a small biopsy. Hopefully someone else can confirm as well @Billy-D2016

 

[hellouser]

I feel like another FAQ thread may be needed.

Why not just add the FAQ to the first post of this thread instead of having so many different threads?

 

[Torin]

Is the writer of the Science Live article just interpreting what we have already read from the Riken and Kyocera press releases or does he know something more?

Kyocera, RIKEN and Organ Technologies are aiming for clinical research in Fiscal Year 2019 (Year ending March 31, 2019), with the goal to put the technologies into practical use in 2020.

Practical use in 2020 must mean start of clinical human trials as per what Tsuji has already said. It's not actual commercialisation date.

Anyway Riken and Kyocera must be working in the clinical research to perfect this method right now which is great. Maybe they are making use of the artificial skin to learn more.

 

[Torin]

@Pray The Bald Away why are you disliking the above post?

People shouldn't get the wrong idea and think that Riken will be commercially available in 2020.

'Disliking' that is like saying you disliking Dr. Tsuji for saying that he aims to start human clinical trials in 2020.

Right now, Riken and Kyocera are laying the groundwork so that these human clinical trials are successful.

 

[Pray The Bald Away]

@Pray The Bald Away why are you disliking the above post?

People shouldn't get the wrong idea and think that Riken will be commercially available in 2020.

'Disliking' that is like saying you disliking Dr. Tsuji for saying that he aims to start human clinical trials in 2020.

Right now, Riken and Kyocera are laying the groundwork so that these human clinical trials are successful.

This following comment is what I disliked. You stated an assumption as fact. I'll "undislike" it, but I want to empasize that what you're saying has no factual basis.

Practical use in 2020 must mean start of clinical human trials as per what Tsuji has already said. It's not actual commercialisation date.

 

[Pray The Bald Away]

Is the writer of the Science Live article just interpreting what we have already read from the Riken and Kyocera press releases or does he know something more?



Practical use in 2020 must mean start of clinical human trials as per what Tsuji has already said. It's not actual commercialisation date.

Anyway Riken and Kyocera must be working in the clinical research to perfect this method right now which is great. Maybe they are making use of the artificial skin to learn more.

“Hello. My name is Hina Morioka from the Corporate Communications Division at Kyocera Corporation. Thank you very much for your question about our research with RIKEN and Organ Technologies.

Regarding timeline, we aim to put the technologies into practical use and make medical treatment available in 2020 in Japan.” -Email to Sets at HLC2020

 

[That Guy]

I wouldn't be too concerned with the "2019 clinical trials" because this is stated literally nowhere else but in that article and the author cites no source for that claim. Save for that 2019 part, that article contains no new information at all - it honestly could just be conjecture to make his article different.

If anyone is really desperate to know how he knows this, is it possible to email him?

Anyway, yeah "practical use IN 2020" has been said right from the get go.

 

[Dench57]

How much do people think this is going to cost? I assume we're completely guessing at this point as I can't remember any mention of price in previous press releases.

Honestly chaps I would be willing to have HairLossTalk.com crowdfund me to get the first treatment, you know so I can see that it's safe and it works. No need to thank me, sacrifices must be made for the greater good.

 

[kj6723]

How much do people think this is going to cost? I assume we're completely guessing at this point as I can't remember any mention of price in previous press releases.

Honestly chaps I would be willing to have HairLossTalk.com crowdfund me to get the first treatment, you know so I can see that it's safe and it works. No need to thank me, sacrifices must be made for the greater good.

so selfless....

 

[hellouser]

How much do people think this is going to cost? I assume we're completely guessing at this point as I can't remember any mention of price in previous press releases.

Honestly chaps I would be willing to have HairLossTalk.com crowdfund me to get the first treatment, you know so I can see that it's safe and it works. No need to thank me, sacrifices must be made for the greater good.

Donate to my cause and I'll donate to yours.

 

[yellowbluegrey]

How much do people think this is going to cost? I assume we're completely guessing at this point as I can't remember any mention of price in previous press releases.

Honestly chaps I would be willing to have HairLossTalk.com crowdfund me to get the first treatment, you know so I can see that it's safe and it works. No need to thank me, sacrifices must be made for the greater good.

I just wanted to say good luck, we're all counting on you

 

[Torin]

“Hello. My name is Hina Morioka from the Corporate Communications Division at Kyocera Corporation. Thank you very much for your question about our research with RIKEN and Organ Technologies.

Regarding timeline, we aim to put the technologies into practical use and make medical treatment available in 2020 in Japan.” -Email to Sets at HLC2020

This has been covered already.

Kyocera will be responsible for developing a cell processing device. Riken are responsible for the actual cell manipulation technology.

The Kyocera corporate communications rep who wrote the email is not privy to Riken's strategy or how far along they are.

Dr. Tsuji has said numerous times he aims to start clinical trials in 2020. How do you suppose they could make it commercially available in the same year? That makes no sense at all.

What the Kyocera rep probably meant was that the Kyocera made equipment will be ready by 2020. In fact Kyocera have said they aim to have their equipment ready by March 2018.

 

[Blackber]

This has been covered already. The Kyocera corporate communications rep is not privy to Riken's strategy or how far they are.

Dr. Tsuji has said numerous times he aims to start clinical trials in 2020. How do you suppose they could make this commercially available the same year as the trials start? It makes no sense.

What the Kyocera rep probably meant was that the Kyocera made injector equipment will be ready by 2020. Kyocera says they aim to have it ready by March 2018.

And you're not privy to what they know and don't know.

I highly doubt a huge company like Kyocera enters into an agreement without know when they will be able to benefit from it - unforeseen delays put aside.

 

[Torin]

And you're not privy to what they know and don't know.

I highly doubt a huge company like Kyocera enters into an agreement without know when they will be able to benefit from it - unforeseen delays put aside.

I repeat, Dr. Tsuji has said numerous times the human clinical trials will start in 2020. I'm sure this is what he told Kyocera too.

But there are those so desperate for a quick fix that instead of listening to Tsuji they prefer to latch on to an email by a general communications representative who doesn't properly understand the separate timelines of Riken and Kyocera and what they mean.

Kyocera equipment will be ready in 2018.

Riken clinical trials will hopefully begin in 2020.

Commercialisation will come at least a few years after this.

Above is the absolute best case scenario if everything goes smoothly.

Member @Swoop who has been in email contact with Dr. Tsuji, estimated a 2026 release as a best case dream scenario before the Kyocera partnership news was announced.

Maybe ask him what he thinks the timeline is now, but I should think his estimate wouldn't change that much because at the end of the day the Riken clinical trials start date remains unchanged (2020). Kyocera's involvement may skim a few years off his earlier estimate.

 

[GotHair?]

http://www.scientistlive.com/conten...ogy-shows-promise-regenerating-hair-follicles

New article mentioning the partership between Kyocera and Riken. Highlighted the most interesting aspects from the article imo.

Kyocera, along with RIKEN and Organ Technologies, has launched a joint research to develop a regenerative medical treatment for hair loss, targeting practical use in 2020.

The partnership aims to develop technologies and products for treating hair loss by regenerating hair follicles. Because no existing treatment can increase the number of hair follicles, any viable method of regenerating hair follicles has great potential to succeed.

The joint research works on a technology to collect stem cells from the patient’s own hair follicles, followed by the processing of these follicles and autografting on the same patient. For the treatment of androgenic alopecia (the most common type), a small number of hair follicles will be collected, from which stem cells will be isolated, cultured and amplified to produce hair follicle germ.

The regenerated hair follicle germ will be packaged and delivered to a medical facility for use in transplantation therapy for the patient. The method furthermore allows control of the hair colour by adding pigment stem cells, and the number of hair follicles regenerated.

Kyocera is responsible for technical aspects such as the development of cell processing devices. While various methods are under evaluation, Kyocera’s piezoelectric technology is of particular interest as a means of discharging small amounts of viscid cells in a precise manner during the cell processing process.

Kyocera is expanding its expertise in creating medical components for orthopedic joint replacement and dental implants to support this future application of regenerative medicine.

Kyocera, RIKEN and Organ Technologies are aiming for clinical research in Fiscal Year 2019 (Year ending March 31, 2019), with the goal to put the technologies into practical use in 2020.


Clinical research in 2019, practical use by 2020!!!!!!

Yo mate, you always bring awesome posts. Keep doing it.
Now for realz. This is the sh*t. Delays are always possible. However if it does what they claim it is the cure. Period.

Now I would also like to address Histogen. I don't understand why people concentrated on th pictures when they should have concentrated on the Phase I/II trial results where you can see they have about 19% terminal hair increase after 3 months:


I think this is solid. If the price is acceptable they can inject multiple injections and it could be the boost until Tsuji comes along.

 

[Pray The Bald Away]

I repeat, Dr. Tsuji has said numerous times the human clinical trials will start in 2020. I'm sure this is what he told Kyocera too.

But there are those so desperate for a quick fix that instead of listening to Tsuji they prefer to latch on to an email by a general communications representative who doesn't properly understand the separate timelines of Riken and Kyocera and what they mean.

Kyocera equipment will be ready in 2018.

Riken clinical trials will hopefully begin in 2020.

Commercialisation will come at least a few years after this.

Above is the absolute best case scenario if everything goes smoothly.

Member @Swoop who has had contact with Dr. Tsuji estimated a 2026 releasd as an best case dream scenario before the Kyocera news was announced.

Maybe ask him what he thinks the timeline is now, but I should think his estimate wouldn't change that much because the Riken clinical trials start date is still the same (2020).

Regenerative medicine requires a vastly different trial process than the typical drug. Drugs require long term tolerance and efficacy studies. RIKEN's treatment involves a one time transplantation that either works or doesn't. This is a low risk stem cell treatment so it carries almost no cancer risk or risk of rejection. RIKEN is also a government funded institution. The Japanese government has been part of the process since the treatment's inception. They have little reason to let the trial process be dragged out in a similar fashion to the American drugs. You're also ignoring the fast tracking that Japan has allowed for stem cell treatments. And you basically just said that you're more informed than one of the three major players' communication professionals. It's almost like you want bad news.

 

[Torin]

You're also ignoring the fast tracking that Japan has allowed for stem cell treatments.

No I'm not.

That's why in my last post I said that commercialisation could follow a few years after the start of clinical trials. So around 2023/24 release might be possible.

Nowhere else could it go that quickly other than Japan and a few other countries. If this was happening in the states then we would be talking more like 2030 (6-9 years of trials as opposed to 2-4).

You're also ignoring the fast tracking that Japan has allowed for stem cell treatments.

And you basically just said that you're more informed than one of the three major players' communication professionals. It's almost like you want bad news.

I'm saying that I rather hear what Dr. Tsuji says than a communication officer who is not in the medical field and probably read the same info we did, namely that Kyocera's device will be ready in 2018 and clinical trials to follow. Where he got mixed up was thinking clinical trials in 2020 might mean commercialisation where in reality it does not.

Many leaders in the hair research field think a cure is still 20 years away. Dr.Claire Higgins is one of them.

I happen to think commercialisation of Riken's tech could be less than 10 years away which would in itself be amazing. But it really depends on everything running smoothly and in life things rarely go as planned.

The research being conducted by Tsuji may benefit from the relaxed Japanese regulations, but it doesn't take away from the fact that this is highly, highly complex, cutting edge medicine. It is yet to be tested on humans. All we know is that research is still ongoing to try and find solutions to the various issues Tsuji still had in late 2015.

 

[That Guy]

I repeat, Dr. Tsuji has said numerous times the human clinical trials will start in 2020. I'm sure this is what he told Kyocera too.

You keep saying this, but you haven't shown us where he's said it. Perhaps he said this in times pre-dating this announcement which as far as I can tell, seems to be the case.

The official news release stated that they aim to put it into practical use in 2020. If the information was incorrect, it would have been updated since (which it has not) or it would never have been published to begin with and allowed to be quoted by sources all across the world.

Your logic here doesn't make any sense. Why would they wait two years after developing autonomous tech to begin human trials? They can begin early human trials now by using a manual process if they really wanted to.

RIKEN is government funded and 2020 would be an ideal year for the government to have the world's first hair-follicle regeneration procedure available as this year is already going to see tons of tourism to Japan due to the 2020 Olympics.

 

[Pray The Bald Away]

No I'm not.

That's why in my last post I said that commercialisation could follow a few years after the start of clinical trials. So around 2023/24 release might be possible.

Nowhere else could it go that quickly other than Japan and a few other countries. If this was happening in the states then we would be talking more like 2030 (6-9 years of trials as opposed to 2-4).





I'm saying that I rather hear what Dr. Tsuji says than a communication officer who is not in the medical field and probably read the same info we did, namely that Kyocera's device will be ready in 2018 and clinical trials to follow. Where he got mixed up was thinking clinical trials in 2020 might mean commercialisation where in reality it does not.

Many leaders in the hair research field think a cure is still 20 years away. Dr.Claire Higgins is one of them.

I happen to think commercialisation of Riken's tech could be less than 10 years away which would in itself be amazing. But it really depends on everything running smoothly and in life things rarely go as planned.

The research being conducted by Tsuji may benefit from the relaxed Japanese regulations, but it doesn't take away from the fact that this is highly, highly complex, cutting edge medicine. It is yet to be tested on humans. All we know is that research is still ongoing to try and find solutions to the various issues Tsuji still had in late 2015.

You cherry picked the statements you chose to address from my comment. Care to address the rest?

 

[Torin]

@kuba197 posted this on b.t.t in June, quoting RIKEN's Facebook page:

Human clinical trials simply cannot be started quickly, for any treatment. It's a process that is highly regulated (for good reason), and takes time. Proposals need to be made and approved, funding needs to be secured, etc. But, don't worry. Dr. Tsuji is working hard. My guess is that they won't start for a few years though ...

@Swoop's email Q&A with Dr. Takashi Tsuji earlier this year:

- What advancements have been made since that study?

We developed a novel hair regeneration using a bioengineered hair follicle germ transplantation. Our method have several advancements such as the control of eruption hair density and hair color, compared to previous studies.


- While success was shown in the rodent model, how do you predict such a bioengineered hair follicle germ will behave when injected into the scalp of a human?

I think that our treatment will succeed in human as well as rodent model. We will isolate the cells from the back of head of scalp patients and then transplant into scalp area. The bioengineered hair follicle will be erupt in the area and the hair is same to that in the back of head.


- Before we can be successful we will also need to be able to mass produce these bioengineered hair follicle germs, right? Based on current advancements it seems to be difficult to culture DPC, because they lose their signature in vitro. How do such problems apply to the current method described in the study?

As you pointed, the problem of our project is the expansion of stem cells in the bulge region and dermal papillae. In these problems, the expansion of epithelial bulge stem cells is critical issue. Thus, we are now trying to expand the stem cells.


- When can we expect that such a method will find their way to testing (clinical trials) in humans? How close are we?

We would like to realize human clinical study at 2020. We will overcome the several hurdles and realize human clinical study within 5 years.

Also I suggest you watch the Science View program segment (original air date: July 19 2016 on Japan's public broadcaster NHK World) about Dr. Tsuji and Riken's work on hair regeneration. Listen to Dr. Mizushima's comments at the end.

The segment about Riken starts at 09:18:

Lastly, at the Hair Congress in Miami Dr. Tsuji gave 2020 as the date he hoped to start human clinical trials.

It could not be any clearer.