Is It True That Replicel Will Be Released This Year?

[Toby0823]

Read the results of the 1st phase. Unless you think it's all lies and a big conspiracy to continue selling propecia. Whatever floats your boat. We'll see phase2 results later this year.

c'ya.

That’s exactly what it is, a bunch of crap. For any research as long as this has been going on for, any success worth talking about would be publicized by every network in the country. This company isn’t keeping anything in secret, yet still, just a bunch of “the science makes sense” and small “teasers”.

What makes better sense are well documented and convincing visual proof of multiple former baldies who now have thick enough hair to style. Not this science crap. Real scientists who’s been in the hairloss industry don’t know the science to hairloss...some balding forum guy definitely wouldn’t know what to even look for.

 

[hanginginthewire]

Friend, I like you and I know you have been waiting patiently.

Phase 1 results were pretty good. 1 time injection. Safe for up to five years even though an "overdose" was given. Majority of patients remained above baseline - miniaturization ceased. A few patients continued balding. Of the few, at least two are suspected of receiving treatment outside protocol - their medication was held up at customs and expired. In a sense this is not speculation. Either the protocol was violated or it wasn't. It isn't unbelievable that these cell cultures have an expiration date.

Phase 1 was *not* powered for efficacy. You will never get your answers about this method's efficacy through the phase one results alone. One can speculate, however, that if the technology were working as intended, the results that we DO see from phase 1 are as we expect.

You've waited this long. You can wait until June-end of the year for the data readout from Shiseido's phase II trial which IS geared toward efficacy to a greater extent.

It is not yet time to celebrate.
But neither is it time to denigrate.
The verdict is not out yet because that data is unavailable.
Such is life, and such is research.
But the odds are favorable. Much more favorable than an Italian lotion with no official studies or pictures but with spectacular claims.

Thanks, appreciate the thoughtful post.

I was reflecting on my exchange above with That Guy while I drove to work, utterly depressed over how sh*t my hair is and how trapped by it I feel. It’s so strange to have That Guy or whoever assuring me of a path forward, juxtaposed with my lived reality of utter frustration and despair. If a treatment comes to pass that helps, BELIEVE ME, I will avail myself of it. Thus my frustration with these phases and pipelines and promises and potential.

And with regard to potentiality, we have reason to be ultra cynical as hair loss sufferers.

But anyway, are you just estimating June for Phase 2 readout or that’s what you’ve seen? Source, if so?

 

[Noisette]

Thanks, appreciate the thoughtful post.

I was reflecting on my exchange above with That Guy while I drove to work, utterly depressed over how sh*t my hair is and how trapped by it I feel. It’s so strange to have That Guy or whoever assuring me of a path forward, juxtaposed with my lived reality of utter frustration and despair. If a treatment comes to pass that helps, BELIEVE ME, I will avail myself of it. Thus my frustration with these phases and pipelines and promises and potential.

And with regard to potentiality, we have reason to be ultra cynical as hair loss sufferers.

But anyway, are you just estimating June for Phase 2 readout or that’s what you’ve seen? Source, if so?

Stay strong bro...

You can see that the clinical trial has begun on july 26th 2016 and the last modified on February this year (2018/02/11)
Replicel said that the read-out will be expected this H2 2018 (page 25)

source: https://replicel.com/wp-content/uploads/2017/03/RP_Presentation-new-2017-02.pdf
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026894

 

[Janks16]

There's no reason for any of this to be discussed until the product actually comes out. Until then, there's just rampant speculation and nonsense that doesn't mean a damn thing... We just need to hold out and hope for the best.

 

[That Guy]

That’s exactly what it is, a bunch of crap. For any research as long as this has been going on for, any success worth talking about would be publicized by every network in the country. This company isn’t keeping anything in secret, yet still, just a bunch of “the science makes sense” and small “teasers”.

What makes better sense are well documented and convincing visual proof of multiple former baldies who now have thick enough hair to style. Not this science crap. Real scientists who’s been in the hairloss industry don’t know the science to hairloss...some balding forum guy definitely wouldn’t know what to even look for.

and yet, you're here.

 

[Desmond_84]

Hi guys, is everyone excited or what?

We've waited 8 years to get our hands on Replicel and we're finally so close I can taste it. I quickly read through the comments and I can assure you, there's no need to be so depressed or worried.

The Shiseido trial has been running for two years now and there's been data readouts throughout the study. There's always one at 3 months, 6 months, 12 months, 18 months and 24 months. If the results so far were unsatisfactory or lackluster, Shiseido would have pulled the plug by now or had gone back to the drawing board to see what has gone wrong. The fact that the trial is pretty much about to finish and they haven't put it on halt or modified the treatment protocol in any way is great news. They must be happy with the results they've seen so far.

 

[Javell]

So, on Tsuji thread there has been debate about the new Japanese stem cell law.
One of the members gave me the following explanation of the law:

Following approval, there will be a post-market surveillance period of five to seven years, after which the treatment will be evaluated again for safety and efficacy. Every patient must be entered in a registry during that period, says Miyata.

@ThatGuy what is your take on this? Can we say goodbye to having a shot of Shiseido in Japan for 7 years?

 

[razzmatazz91]

Hi guys, is everyone excited or what?

We've waited 8 years to get our hands on Replicel and we're finally so close I can taste it. I quickly read through the comments and I can assure you, there's no need to be so depressed or worried.

The Shiseido trial has been running for two years now and there's been data readouts throughout the study. There's always one at 3 months, 6 months, 12 months, 18 months and 24 months. If the results so far were unsatisfactory or lackluster, Shiseido would have pulled the plug by now or had gone back to the drawing board to see what has gone wrong. The fact that the trial is pretty much about to finish and they haven't put it on halt or modified the treatment protocol in any way is great news. They must be happy with the results they've seen so far.

Data read outs every three months?
Source? Links?

 

[razzmatazz91]

So, on Tsuji thread there has been debate about the new Japanese stem cell law.
One of the members gave me the following explanation of the law:

Following approval, there will be a post-market surveillance period of five to seven years, after which the treatment will be evaluated again for safety and efficacy. Every patient must be entered in a registry during that period, says Miyata.

@ThatGuy what is your take on this? Can we say goodbye to having a shot of Shiseido in Japan for 7 years?

Yeah... that isn’t encouraging at all.
But we will need more info about the laws involved here.

For instance, we need to answer whether Shiseido will be able to offer the treatment anywhere else in Asia after preliminary approval in Japan is granted. If so, One can probably go ahead and get it.

Also, we need to answer whether there is a mechanism in place to follow up with patients from abroad. For instance, a contract that requires you to do regular blood tests etc. and send reports back to Japan.

We need skilled lawyers working on these questions, not just some balding men on an Internet forum.

 

[Javell]

Yeah... that isn’t encouraging at all.
But we will need more info about the laws involved here.

For instance, we need to answer whether Shiseido will be able to offer the treatment anywhere else in Asia after preliminary approval in Japan is granted. If so, One can probably go ahead and get it.

Also, we need to answer whether there is a mechanism in place to follow up with patients from abroad. For instance, a contract that requires you to do regular blood tests etc. and send reports back to Japan.
.

I found another paragraph of the article from which @IdealForeheadtook his info:

Doug Sipp worries whether post-market surveillance will turn up relevant data. Sipp, who studies regulatory issues related to stem cells at the RIKEN Center for Developmental Biology in Kobe, Japan, says that making people who receive the therapies during this period cough up even the 30% co-pay generally required under Japan’s national insurance plan “will essentially be asking patients to pay for the privilege of serving as the subjects of medical experiments.” And since the patients are paying, the studies cannot be randomized or blinded. Paying patients are also more likely to experience placebo effects, Sipp warns.
https://zedie.wordpress.com/2013/05...-track-approval-path-for-stem-cell-therapies/

It seems that it has something to do with insurance.

 

[Desmond_84]

Data read outs every three months?
Source? Links?

Information on Shiseido's trial design specifics is quite scarce and is most likely due to it being in Japanese.

Nevertheless, pretty much all Phase 2 Androgenetic Alopecia trials are designed that way. Hair count and patient safety is assessed after 3, 6, 12, 18 and 24 months. Finasteride, Minoxidil, Aderans, etc were all designed that way.

At each time point, the readouts are collected by the CRA (Clinical Research Associate) and sent to a third party organisation to analyse. A report is then collated and sent to the Clinical trial research team, who continually assess whether to continue or discontinue the trial.

The fact we're finally about to finish a Phase 2 trial and there are no hiccups is incredible! Those that were around 5 years ago clearly remember all the drama with Aderans during their Phase 2 trial. It went on for 5 years due to the multiple tweaks they had to make to the treatment protocol to no avail. Ji Gami 1, 2, 3 and 4 all failed to produce results similar to finasteride and Minoxidil. Their parent company finally pulled the plug on them and they had no funds left to continue the trials.

 

[NorwoodGuardian]

and yet, you're here.

Shill. You don't know?

 

[Desmond_84]

So, on Tsuji thread there has been debate about the new Japanese stem cell law.
One of the members gave me the following explanation of the law:

Following approval, there will be a post-market surveillance period of five to seven years, after which the treatment will be evaluated again for safety and efficacy. Every patient must be entered in a registry during that period, says Miyata.

@ThatGuy what is your take on this? Can we say goodbye to having a shot of Shiseido in Japan for 7 years?

Yeah, I had a read of it too. It is a bit concerning but we can only hope Don't forget if Shiseido is approved, it will be the 6th regenerative medicine that has gone through the accelerated pathway. And from what I've read, nothing seems to be set in stone over there as of yet. I wouldn't be surprised if they haven't fully thought it through about what happens to the foreigners flocking to their country for the treatment.

It seems like Japan's regulatory body is no where near as pushy or powerful as FDA. I don't think they'll try and block any medical tourism happening, thanks to the accompanying dollars that will be flowing into their country.

 

[dermrafok]

 

[That Guy]

So, on Tsuji thread there has been debate about the new Japanese stem cell law.
One of the members gave me the following explanation of the law:

Following approval, there will be a post-market surveillance period of five to seven years, after which the treatment will be evaluated again for safety and efficacy. Every patient must be entered in a registry during that period, says Miyata.

@ThatGuy what is your take on this? Can we say goodbye to having a shot of Shiseido in Japan for 7 years?

I'm kind of confused why people are just noticing that now, it's been said from the get go.

This goes back to what I said when this was first discussed, and no one listened to me, I was a dumbass, etc. when I suggested that they may only treat Japanese citizens.

If every patient must be registered in a database, which I doubt is too hard to do and it makes sense given its "conditional" market approval, it stands to reason that they may not treat international patients because I could see an argument being made for those patients being too much of a liability under a "conditional" therapy.

But maybe not, though — I'm no legal expert.

 

[Omega2327]

Friend, I like you and I know you have been waiting patiently.

Phase 1 results were pretty good. 1 time injection. Safe for up to five years even though an "overdose" was given. Majority of patients remained above baseline - miniaturization ceased. A few patients continued balding. Of the few, at least two are suspected of receiving treatment outside protocol - their medication was held up at customs and expired. In a sense this is not speculation. Either the protocol was violated or it wasn't. It isn't unbelievable that these cell cultures have an expiration date.

Phase 1 was *not* powered for efficacy. You will never get your answers about this method's efficacy through the phase one results alone. One can speculate, however, that if the technology were working as intended, the results that we DO see from phase 1 are as we expect.

You've waited this long. You can wait until June-end of the year for the data readout from Shiseido's phase II trial which IS geared toward efficacy to a greater extent.

It is not yet time to celebrate.
But neither is it time to denigrate.
The verdict is not out yet because that data is unavailable.
Such is life, and such is research.
But the odds are favorable. Much more favorable than an Italian lotion with no official studies or pictures but with spectacular claims.

Everyone on this forum should strive for this level of emotional intelligence. @d3nt3dsh0v3l for prez.

 

[wilfred]

https://replicel.com/replicel-life-...vestment-partnership-with-china-based-yofoto/

 

[KSA]

if it works, it will most certainly be available around APAC + Middle East where regulations on dermo-cosmetics/surgeries are practically unheard of. If it doesn't yield relevant results, it will still probably be available lol