Response From Tsuji Team. Sort Of...

[Admin]

HairLossTalk:

How are you? Hope you have been doing well.

Thank you once again for coordinating the interview with the Tsuji team a few months ago.

Some prominent members have asked me to inquire with your team, to see how your efforts to find a solution to the inductivity (functionality) problem is coming along?

To be more specific:

Mr. Toyoshima stated: "For applications of our technology, both mesenchymal stem cells and epithelial stem cells, which are applicable to human clinical applications, are needed. With respect to the development of the technology to cultivate mesenchymal stem cells, that is papilla cells, being applicable to human clinical trials, we are already in progress now for development. On the other hand, as for the technology to cultivate epithelial stem cells of follicles, it still remains a significant challenge globally. We are currently in the middle of research and development for this. Based on our recent research results, we finally have some prospects and expect this issue to be resolved in the near future."

We were interested in learning if you have made any progress with the difficulties of culturing the epithelial stem cells?

Thank you.

----------------

Tsuji Team:

Dear Kevin,

I'm excellent! And you? Long time no see.

Thank you for your interest.

Our research progresses as planned.

First-in-human will start in early-2019 after regulatory notification on our technology as a class 2 regenerative medicine.

Best regards

 

[pegasus2]

At least we know by mid 2019 if it works.

 

[nameless]

HairLossTalk:

How are you? Hope you have been doing well.

Thank you once again for coordinating the interview with the Tsuji team a few months ago.

Some prominent members have asked me to inquire with your team, to see how your efforts to find a solution to the inductivity (functionality) problem is coming along?

To be more specific:

Mr. Toyoshima stated: "For applications of our technology, both mesenchymal stem cells and epithelial stem cells, which are applicable to human clinical applications, are needed. With respect to the development of the technology to cultivate mesenchymal stem cells, that is papilla cells, being applicable to human clinical trials, we are already in progress now for development. On the other hand, as for the technology to cultivate epithelial stem cells of follicles, it still remains a significant challenge globally. We are currently in the middle of research and development for this. Based on our recent research results, we finally have some prospects and expect this issue to be resolved in the near future."

We were interested in learning if you have made any progress with the difficulties of culturing the epithelial stem cells?

Thank you.

----------------

Tsuji Team:

Dear Kevin,

I'm excellent! And you? Long time no see.

Thank you for your interest.

Our research progresses as planned.

First-in-human will start in early-2019 after regulatory notification on our technology as a class 2 regenerative medicine.

Best regards

Thanks for trying to figure out where Tsuji stands with the inductivity issue Admin.

They didn't come out and say if they have or haven't solved the inductivity problem. They did say things are progressing. I think that means they're making some headway at least.

It looks like they plan to start human trials in 2019. I think that means it won't be available in 2020. It looks like the date has moved to 2021, if it works.

 

[Omega2327]

Would it be too forward to push him on this a bit more? I agree that it's good to hear they're making progress as planned but he didn't answer the question directly at all when the question was very specific. The inductivity problem is everything. It's the whole ball game.

 

[nameless]

Would it be too forward to push him on this a bit more? I agree that it's good to hear they're making progress as planned but he didn't answer the question directly at all when the question was very specific. The inductivity problem is everything. It's the whole ball game.

I think we should wait at least 4 - 6 months before we go back there.

They understood the question Admin was asking and they decided not to answer it at this time. That means they don't want to say where they're at with the inductivity issue yet.

It's great that they talk to Admin and we should protect that by not being pushy with Admin or Team Tsuji.

 

[Omega2327]

You're probably right. I'll just be here shedding in the meantime.

 

[nameless]

I'll just be here shedding in the meantime.

I know.

Me too.

But we do want to protect Admin's backline to Tsuji.

 

[pegasus2]

It looks like they plan to start human trials in 2019. I think that means it won't be available in 2020. It looks like the date has moved to 2021, if it works.

Not necessarily. They only need two trials before they can commercialize it, and they don't have to be long ones. A small trial to show safety, and then one more to show efficacy. They will know very quickly if it works or not. I could easily see them applying for conditional approval one year after beginning human trials. A few months to get approval, and another few months to finish preparations and begin marketing. Mid to late 2020 is well within reason if all goes well.

 

[baldingAF]

I don't know man, they're gonna need some money for that...... oh wait these mothers are rich af. 2020 all the way

 

[Admin]

The "Sort of..." in the title was definitely in regards to them not answering.

For context, here is their response regarding first human trials from our interview back in Sept 2016:

We need to ... obtain a regulatory notification on our technology as a Class 2 Regenerative Medicine. The clinical study starts only after we receive that notification. Therefore we are thinking to start a small-scale clinical study to evaluate its safety and effectiveness in 2018.

Today's response:

First-in-human will start in early-2019 after regulatory notification on our technology as a class 2 regenerative medicine.

So a bit of a slip in the timeline. But no reason to assume its because they've been hitting more roadblocks. Could be a million things, including red tape related to the regulatory notification.

 

[That Guy]

They didn't come out and say if they have or haven't solved the inductivity problem. They did say things are progressing. I think that means they're making some headway at least.

 

[Hangin'on Hair]

Italian Hairloss lotion to be released 2016.

Sound familiar..... I wouldn't have high hopes for a 2019 trial. Not trying to be negative, but this is usually how it goes.
And even when it is ready to go, I don't think i'll be able to drop the $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ on it, no matter how desperate I am.

 

[Dante92]

Why am I not surprised? LOL at those who thought it would have ended differently.

 

[kiwipilu]

I think we should wait at least 4 - 6 months before we go back there.

They understood the question Admin was asking and they decided not to answer it at this time. That means they don't want to say where they're at with the inductivity issue at this time.

It's great that they talk to Admin and we should protect that by not being pushy with Admin or Team Tsuji.

Protect what? this is the #1 international hairloss forum.. I am pretty sure Tsuji team know that, and that's why he answered the question in the first place.The guy has all the time in the world to write his reply, admin is not harrasing him every second: At the end this is just a "friendly" common correspondence on a particularly exciting subject. Btw japanese people don't bother, they are dedicated they will always answer. The respect like I said is to let them time to answer

 

[Abelibano]

One positive aspect of Tsuji's Team treatment is that even if there is a great delay, you will get your hair back for sure (Unlike other current competitive drugs etc who are for maintenance or early hairloss stages)

If they succeed in this, the ramifications are HUGE, because Im most certain that other type of organs are coming next

 

[Trichosan]

Yes, we will soon be able to choose the amount, pattern and color of hair we desire. And the type, size and color of organ too. Yeah, Baby!!

 

[GotHair?]

The delays are not a problem. They will be up to a year at most. The problem is that people here who expect this treatment to be available in 2020 TO THEM will most likely be disappointed. They plan to offer the treatment to 10000 patients in the year it comes out.
Hence we will have to wait a little longer cos' I'm thinking the Japanese will grab those spots like a pauper grabs a wad of 100 dolar bills.
That said this is the cure. Once it comes out it is time to get it than get a bunch of cocktails and wait for your new mane to grow out...

The price still remains a question. WE'll see when it comes out.

 

[bigentries]

I can't understand why people argue so much about possible release dates and leave efficacy out of the question

I only care if the thing works or not. If it works I'm pretty sure they will make all the efforts to release it as soon as possible. They want our money after all

 

[bigentries]

It deffs works

Works enough to deserve commercialization? That's what I mean, I want to see undisputed evidence of it being a viable treatment. I'll care about release dates after that

 

[nameless]

The "Sort of..." in the title was definitely in regards to them not answering.

I noticed that.

 

[Grasshüpfer]

You're probably right. I'll just be here shedding in the meantime.

© @whatevr

 

[Grasshüpfer]

The "Sort of..." in the title was definitely in regards to them not answering.

For context, here is their response regarding first human trials from our interview back in Sept 2016:

We need to ... obtain a regulatory notification on our technology as a Class 2 Regenerative Medicine. The clinical study starts only after we receive that notification. Therefore we are thinking to start a small-scale clinical study to evaluate its safety and effectiveness in 2018.

Today's response:

First-in-human will start in early-2019 after regulatory notification on our technology as a class 2 regenerative medicine.

So a bit of a slip in the timeline. But no reason to assume its because they've been hitting more roadblocks. Could be a million things, including red tape related to the regulatory notification.

What do you guys expect?

They can't announce that they managed to cultivate epithelial cells in an email. If they manage, they will write a paper about it, it will be published in nature, checked and verified and hit the biotech world like a bomb.

You have to imagine what they do now as a series of experiments: They set up a cell culture, wait two weeks: nothing. Looking for mistakes, next try: nothing. And so on until they finally manage.

How many tries it takes is as hard to predict as how long it takes any of us to train for a marathon. A year? More? We train for three months, try it, fail after 25km, continue training.

For me saying that they are on track is good news and honestly the best possible outcome that was actually realistic at this point.