Japan stem cell laws (fast track)

[James7]

Just starting this thread so we can collect/share information and discuss the details of the new Japanese 'fast-track' stem cell laws.

The Japan Times:

http://www.japantimes.co.jp/news/2013/11/20/national/bills-passed-on-regenerative-meds/#.U9_TEaNZhCO

Wall Street Journal (press release):

http://online.wsj.com/article/PR-CO-20131124-900716.html

Nature magazine (5th paragraph):

http://www.nature.com/news/seven-days-22-28-november-2013-1.14242

Japan has passed two regenerative medicine laws on 20th November 2013.

One law speeds the approval of stem cell treatments by no longer requiring candidate therapies to pass the rigorous (and enormously expensive) phase 3 clinical trials to prove efficacy.
Another law requires physicians to report the clinical use of unapproved stem-cell therapies to the Japanese health ministry.

'The new regulations will be implemented within a year.' (says Nature Magazine).

So I gather from this, that companies need to just prove safety and complete their phase 2.
They can then market their commercial product.
And I expect the efficacy of the treatment, will then determine the product's commercial success.

Safety of course is the most important factor, so I'm pleased about that.
Seems that proof of efficacy is not required, as far as I can tell from these articles?

Since the laws have already been passed, to be honest I'm not sure what the 'implemented in a year' means exactly, unless they are refering to when the first stem cell companies happen to be processed under this new law?
From looking at past clinical trials, it always seems to be the enormously expensive phase 3 that in the past have just halted companies in their tracks before.

When reading about these new laws, as long as they complete phase 2 and prove safety, it seems certain that Replicel and Histogen will come to market and be available.
So I guess we might all be booking some tickets to Asia in the near future?

So let's discuss this, and if you have any more info/details on this, that's great too! add it all below

[hellouser]

It's been discussed before and I've mentioned it before in other Replicel threads that they would NOT necessarily need Phase II completion in order to roll out a treatment. Japan's regulations (or now deregulation) allows stem cell therapies to make it for consumer use DURING phase II trials but conditionally. See the graph below:

[joachim]

this means, if someone finds a cure today, and if this company is eager to release the treatment asap, then they could do so within about 2 years, instead of 10 years. is that correct?

[hellouser]

this means, if someone finds a cure today, and if this company is eager to release the treatment asap, then they could do so within about 2 years, instead of 10 years. is that correct?

Yes, but don't let guys like ShookOnes know about this otherwise he'll call you a parasite.

[sascha]

hahahah +1 hell. Don't let this guy get to you, I am on your side

[JZA70]

this means, if someone finds a cure today, and if this company is eager to release the treatment asap, then they could do so within about 2 years, instead of 10 years. is that correct?

I have a feeling that most teams would establish their treatment/technology in their homeland area.

Jahoda would market his technique in the U.K, Christiano would do the U.S, Lauster would do Europe Etc.

Tsuji Labs are the ones to watch for as they're based in Japan. They could bring something big to the table long before all the other teams could.

[hellouser]

this means, if someone finds a cure today, and if this company is eager to release the treatment asap, then they could do so within about 2 years, instead of 10 years. is that correct?

Back on topic though... seeing how Shiseido is funding Replicel and is based out of Japan, and *might* have their own labs, we really should badger the shit out of Replicel asking them (forcing) to take advantage of the new regulations. They're starting Phase II this year, and David Hall mentioned results in 2016 in a recent interview (press releases indicated 2017 via a 39 month Phase II trial). Imagine, if halfway through that they could give us treatment? Essentially, in less than 2 years?

And yet.... everyone prefers to be a naysayer?

[bananana]

Good news, keep up the good work hell.
I just ignore the pessimists here, no point arguing.

[joachim]

Back on topic though... seeing how Shiseido is funding Replicel and is based out of Japan, and *might* have their own labs, we really should badger the shit out of Replicel asking them (forcing) to take advantage of the new regulations. They're starting Phase II this year, and David Hall mentioned results in 2016 in a recent interview (press releases indicated 2017 via a 39 month Phase II trial). Imagine, if halfway through that they could give us treatment? Essentially, in less than 2 years?

And yet.... everyone prefers to be a naysayer?

i had the same thoughts on that, too.
but the only chance i see this happening is if they can get some good initial results, let's say at least hairloss stop (difficult to measure in short timeframe) and some good regrowth of 20% or so. actually i'm not sure if it's regrowth or denovo follicle creation. i would love to see denovo follicles sprouting. even if the yield is low, you probably can go in for multiple treatments. so even if you get only a few hundred hairs with each treatment, this would be huge and basically the cure, if multiple treatments do the job. while writing this i just noticed that hairloss stop wouldn't be necessary at all if there is some serious denovo hair follicle creation.

does the trial really take 39 months? for phase 2 dosing or what? we can only hope that their first dosing leads to good results. hopefully they will publish them in some way then.

[nameless]

i had the same thoughts on that, too.
but the only chance i see this happening is if they can get some good initial results, let's say at least hairloss stop (difficult to measure in short timeframe) and some good regrowth of 20% or so. actually i'm not sure if it's regrowth or denovo follicle creation. i would love to see denovo follicles sprouting. even if the yield is low, you probably can go in for multiple treatments. so even if you get only a few hundred hairs with each treatment, this would be huge and basically the cure, if multiple treatments do the job. while writing this i just noticed that hairloss stop wouldn't be necessary at all if there is some serious denovo hair follicle creation.

does the trial really take 39 months? for phase 2 dosing or what? we can only hope that their first dosing leads to good results. hopefully they will publish them in some way then.

Shisheido is working with technology that still only solves some of the problems. They're a little more advanced than Aderans but they are still missing important pieces of the puzzle. There are still unresolved issues when it comes to trichogenicity and a reduction of fat cells in the scalp. And more technical obstacles may come up as they move further through trials. Even if no other obstacles show up the incomplete trichogenicity puzzle and the lack of a solution to the reduction of fat cells in the scalp will limit success and permanence. The technology is not ready yet for success. Scientists still need to get more information and solve technical problems before cell-based therapies can work satisfactorily. The science discovered yet - that's the biggest problem. Then when the science is finally discovered you will face the obstacle that the companies working on cell-based therapies and/or the Japanese government may be unwilling to allow early marketing for the cell-based hair therapies. And even if they will you are going to find costs are out of this world because what the companies will be doing will be incredibly advanced hair transplants. It will basically be a hair transplant except that they will have to produce lab follicles because people's donor's areas are insufficient plus they will have to do work on the scalp to make it healthy for the lab grown follicles to live in. This is going to be very VERY expensive.

[sascha]

i had the same thoughts on that, too.
but the only chance i see this happening is if they can get some good initial results, let's say at least hairloss stop (difficult to measure in short timeframe) and some good regrowth of 20% or so. actually i'm not sure if it's regrowth or denovo follicle creation. i would love to see denovo follicles sprouting. even if the yield is low, you probably can go in for multiple treatments. so even if you get only a few hundred hairs with each treatment, this would be huge and basically the cure, if multiple treatments do the job. while writing this i just noticed that hairloss stop wouldn't be necessary at all if there is some serious denovo hair follicle creation.

does the trial really take 39 months? for phase 2 dosing or what? we can only hope that their first dosing leads to good results. hopefully they will publish them in some way then.

yes Replicels trial lasts an estimated 39 months, but that is not the case with Shiseido. They bought Replicels method, they do not cooperate with them, ergo Replicel does their trial and Shiseido does its own trial of length influenced by new regulations. Shiseido got the license to sell this treatment in Asia and Replicel gets a nice slice of that cake.
As far as I understood: Replicel will get more than 100 data points, far more than they got in phase 1. Since the treatment worked already in phase 1(maybe not like many expected) I am pretty sure it will work also for Shiseido. The question is to what degree? They could make this treatment partially available very soon, but than they would have little data points and it would basically work on a level as presented in Replicels phase 1 trial. This is all I think to know

[caddarik79]

http://www.newscientist.com/article/dn26001-stem-cell-scientist-found-dead-in-apparent-suicide.html?utm_source=NSNS&utm_medium=SOC&utm_campaign=hoot&cmpid=SOC|NSNS|2013-GLOBAL-hoot#.U-Iy8hBnPng

[Sogeking]

http://www.newscientist.com/article/...t#.U-Iy8hBnPng

I fail to see how does this have anything to do with this thread?

[JZA70]

This was posted on RepliCel's Twitter page:

“RepliCel/Shiseido is well positioned to take advantage of early conditional approvals in Japan," @CellTherapyBlog

http://www.celltherapyblog.com/

[hellouser]

This was posted on RepliCel's Twitter page:

“RepliCel/Shiseido is well positioned to take advantage of early conditional approvals in Japan," @CellTherapyBlog

http://www.celltherapyblog.com/

HOLY SHIT!!!

That's the BEST positive news we've had all year!!! God damn, I'm so glad I was right on the money about this! Let's hope they actually go through with it!

We should be flooding their emails with requests for early treatment!