New Article on Shiseido Trial

[youngl]

Phase 2 not started yet? http://replicel.com/product-pipeline/

Sorry I'm so confused. Thought there is only one more phase to go before commercialization.

 

[br1]

As far as I understood, if they start it this year the (optimal) timeline would be:

2016 - start trial (duration: 2 years)
2017 - trial
2018 - end trial, working on getting it to the market.

 

[Blackber]

I'm cautiously optimistic about this treatment being a major breakthrough. There's obviously a small part of me that will "believe it when I see it", but Shisiedo is such a big company and it seems like they're really throwing their weight behind this by building the facility in Kobe and that makes me feel good. I can't see them investing all that money if they didn't think they were onto something.

A lot of people will lose hope and bash Replicel/Shiseido due to delays but as Hellouser stated in this post - http://www.hairlosstalk.com/interac...take-so-long?p=1276249&viewfull=1#post1276249 - most of the delays are not due to these companies. I'm sure they'd all love to fly through the trials as fast as possible.

Shiseido is such a big company that I don't think any delays will be due to funding issues. Lee Buckler said all these Japanese regulations are new and the Japanese agencies are still figuring things out themselves as well.

We'll just have to hold steady and see what happens.

Phase 2 not started yet? http://replicel.com/product-pipeline/

Sorry I'm so confused. Thought there is only one more phase to go before commercialization.

My understanding is that if Shiseido can show "probable efficacy" they can bring this treatment to commercialization before Phase II is completed, but again they have to show probably efficacy which will take some time that's why they are shooting for 2018.

 

[Tracksterderm]

Why haven't RepliCel initiated their phase II trial?

I know Shiseido is waiting for Japanees governments approval with the new regulations. But don't RepliCel have to get approval in US/Europe etc to start business in those markets? Or is it possible to use any trial results from Japan in western countries?

 

[Pray The Bald Away]

Why haven't RepliCel initiated their phase II trial?

I know Shiseido is waiting for Japanees governments approval with the new regulations. But don't RepliCel have to get approval in US/Europe etc to start business in those markets? Or is it possible to use any trial results from Japan in western countries?

Shiseido certainly seems to be taking more initiative in getting a product on the market.

 

[Baldybald1]

The question is why replicel keep loosing money and investors ?

 

[wilson2]

I hope this works. I'm over here trying to maintain with Tricomin. haha

 

[Chrisolution]

This will be released in 2018 & commercialized no doubt.

The Japanese government is in desperation mode economically. When you drop interests rates below 0% which is unheard of & a hailmary attempt to stimulate economy. With their new cell based treatment bill the Jspanese need a flagship product that can demonstrate to the world research in Japan & invest in Japan. Cancer, organs, etc.. is too risky, hair loss is adequately safe considering the other treatments. This would be a perfect example of a Canadian company partnering & investing in Japan. Not to mention the 5 years of bald men/women flying to Japan & spending money.

What I am trying to say is the government will be extremely lax legally if Shiseido wants to bring this treatment to market asap.

When I say the Japanese are desperate for something to stimulate the economy believe me they are desperate.

 

[paxis]

Which Norwood would you need to restore all your hair or at least get a Norwood 2 with this treatmant? I know no one knows this exactly.. but maybe a guess?

 

[Blackber]

Which Norwood would you need to restore all your hair or at least get a Norwood 2 with this treatmant? I know no one knows this exactly.. but maybe a guess?

As mentioned many times, Replicel is aiming for hair regeneration which would be a "functioning cure" - i.e. you would get all your hair back. No one knows how effective it will be, if at all.

 

[Aliens]

Hi all.


I am really new here and I got excited by this new. Do you guys think that this method can be applied to people who already got an hair transplant procedure? I mean wouldn't it be problematic that pre hair transplant hairs and hair transplant hairs could be stimulated at the same time? I mean on one point you could have two hair growing no? Or maybe that hair transplant procedure kill the hair not growing behind the skin anyway when implanting the new one?


Well I hope you get what I mean that is a little difficult to explain!


Thank you for your opinion!

 

[Follisket]

Hey, Aliens. That's actually a good question, and one some of us have raised before. But sadly - and weirdly - we've no real answer to that yet. Most seem to just take the word of hair transplant surgeons, who claim hair transplants won't interfere with future treatments but given that we've no actual studies (or even anecdotal evidence), I'm a bit wary.

I mean, we're talking about people who stand to make a nice sum of money from me getting the procedure done and absolutely nothing to lose by deceiving me. I only have the one head so I want to be dead certain.

The only way I can think of is checking with a transgender male-to-female person who's had a hair transplant prior to hormone therapy (and subsequent hair regrowth). I don't know any though. Anyone else maybe?

 

[NewUser]

My understanding is that if Shiseido can show "probable efficacy" they can bring this treatment to commercialization before Phase II is completed, but again they have to show probably efficacy which will take some time that's why they are shooting for 2018.

That's right, demonstrating "probable efficacy" is something new in Japan as of 2014.

Under the PMD Act, a RMP can obtain expedited conditional marketing authorization on the basis of safety and predicted probable efficacy demonstrated in early stage clinical trials.

 

[distracted]

Pretty sure that was one of Hellouser's question for them at the Hair Conference. I'd suggest checking that out, but I'm pretty sure they said that Replicel should work hair transplant or no hair transplant

 

[kiwipilu]

SEE " Replicel Presentation in Toronto, Jan 29th 2016 - Japan Regenerative Medicine Market"

I'm sure you already have this one but there we go
"If you had a hair transplant or plan to have a hair transplant, will this interfere with the treatment."
thanks !

I'll answer this now:

No. Not at all. It's not invasive and doesn't destroy follicles. It'd only enhance things.

 

[thinning13]

new here, but have been following the forum for a while. has there been any consensus reached on whether replicel will work for the unfortunate few like myself who have thinning in the back and sides also? trying not to get my hopes up too much in case this treatment wont work for me.

 

[youngl]

Replicel announced that Sheisido was to start the trials any day or week now, that was in the beginning of November. Five months went by then, trials still haven't started. So sorry if I lost hope that this will reach market in the next ten years, if at all.

Yes they are very bad at their timings.

This will be released in 2018 & commercialized no doubt.

The Japanese government is in desperation mode economically. When you drop interests rates below 0% which is unheard of & a hailmary attempt to stimulate economy. With their new cell based treatment bill the Jspanese need a flagship product that can demonstrate to the world research in Japan & invest in Japan. Cancer, organs, etc.. is too risky, hair loss is adequately safe considering the other treatments. This would be a perfect example of a Canadian company partnering & investing in Japan. Not to mention the 5 years of bald men/women flying to Japan & spending money.

What I am trying to say is the government will be extremely lax legally if Shiseido wants to bring this treatment to market asap.

When I say the Japanese are desperate for something to stimulate the economy believe me they are desperate.

I doubt it. They aren't one of 5 years away company... but they take 1 week to max 2 half years . and so on. who knows.

 

[Pray The Bald Away]

new here, but have been following the forum for a while. has there been any consensus reached on whether replicel will work for the unfortunate few like myself who have thinning in the back and sides also? trying not to get my hopes up too much in case this treatment wont work for me.

Most people with DUPA still have a very small section on the back of the head that doesn't miniaturize. If cells can be isolated from this section then I don't see why it wouldn't work. Also, you could probably isolate cells from the miniaturizing hairs and it perhaps could repopulate your head with hairs that might miniaturize again in the distant future. If you did this every 10 or 20 years, this could stil be a functional cure for you' provided the treatment works in the way they say it will.

 

[Mr White]

Could be that repeat injections are required later on, thus repeat business. But the flight to Japan and hotels will bring up costs by a LOT, so they're going to HAVE TO take that into consideration.

I couldn't read the original article but if Hellouser likes it, it's fine by me.

These guys were always my favourites, let's keep our fingers crossed.

This is probably a stupid question but here it goes: Why only in Japan? Any chance we could get this in Europe and when?

 

[br1]

I couldn't read the original article but if Hellouser likes it, it's fine by me.

These guys were always my favourites, let's keep our fingers crossed.

This is probably a stupid question but here it goes: Why only in Japan? Any chance we could get this in Europe and when?

Seems like it is because Japan has new laws for that kind of research (stem cells) which makes it faster for companies to release their products.