A law on regenerative medicine and applications of stem cells, passed in November 2013 [1], has entered into force on 25 November 2014. This new legislation allows companies to grow cells with the capacity to regenerate body tissues. So far, only medical institutions were allowed to use the technology.
In this context, the Japanese cosmetics firm Shiseido reaffirmed its ambition to develop a hair restoration technique by culture and growth of cells. Having acquired the technology exploitation rights developed for this purpose by the Canadian RepliCel company in 2013, Shiseido has established a research laboratory in Kobe and works with a medical clinic, with the goal of commercializing this technology by 2018.
The idea is to take a sample of 5 mm from the scalp at the back of the patient's head (area where typically the follicles remain active throughout life), grow and multiply cells with technology developed by RepliCel, and finally inject the cells into the bald areas of the scalp.
This implantation of autologous cells (ie from the same person) should allow the resumption of hair growth in these areas, with the major advantage of requiring only a slight response given the size of sample to be taken. In addition, the risk of rejection would be very low and the method could be used regardless of gender and configuration of the patient's alopecia.
12-17-2014 12:24 PM
joely
Ha so still a four year wait! better than the 5 years one I suppose! that's assuming this works
12-17-2014 12:40 PM
macbeth81
The 2018 estimate is from Shiseido's new release in 2013 below. Apparently, the Japanese have a sense of humor. I am more interested in what technology they are combining with RepliCel's. Hopefully they can improve this technology and release in a timely matter. I do not trust RepliCel due to their track record. I know since 2013 they had issues with their cell culturing, so I don't know if that delays their commercialization plans.
Quote:
Shiseido will combine RepliCel’s hair regenerative medicine technology and Shiseido’s technology and aim to commercialize safe and effective hair regenerative medicine that integrates beauty and medicine to help those concerned about pattern baldness and thinning hair in the next 5 years by also cooperating with specialists in the future.
Dammit, is FUE still the only thing we got? (aside from crap minoxidil and fin)
12-18-2014 10:51 AM
Kudu
I would take this with a pinch of salt, that was before the law even went into effect and didn't they just say they were moving forward recently? I personally think that RepliCell will hit the market in Japan around late 2016-early 2017. It could be longer, but beating ourselves up over timelines won't help anything. All I know is that they want to get this out as soon as they can, they wouldn't be taking advantage of the laws of that weren't the case.
12-18-2014 12:29 PM
hellouser
Quote:
Originally Posted by Kudu
I would take this with a pinch of salt, that was before the law even went into effect and didn't they just say they were moving forward recently? I personally think that RepliCell will hit the market in Japan around late 2016-early 2017. It could be longer, but beating ourselves up over timelines won't help anything. All I know is that they want to get this out as soon as they can, they wouldn't be taking advantage of the laws of that weren't the case.
Replicel itself said they intend on taking advantage of the new legislation. Shiseido would more than likely want to capitalize on it too So far as we know; replicel gave 'decent' results at 6 months with no side effects, no donor depletion, the potential (likely) to halt further loss and the ability to go in for repeat sessions... why not go for a quick turnaround. The biggest deal breaker is that they ONLY have 6 month results and as we all SHOULD know, even existing follicle transplanted from the back to the front take up to and over 12 months for FULL results.. as in; healing, shock loss, full hair growth cycle between all stages (anagen, catagen, telogen and a 4th but lesser known cycle) and then of course the actual hair GROWTH period above the skin which is also slow at 1cm/month. So yeah... we really dont know the full potential of Replicel.. but i wouldnt be surprised if Replicel's new cells combined with growth factors would give even GREATER results and faster, kind of like a boost.
12-18-2014 04:25 PM
rambo007
The good thing is that Replicel's theory was now validated by researchers from Calgary. Replicel confirms that on Facebook and Twitter.
12-18-2014 04:36 PM
hellouser
Quote:
Originally Posted by rambo007
The good thing is that Replicel's theory was now validated by researchers from Calgary. Replicel confirms that on Facebook and Twitter.
It was never validated by the Calgary researcher (Dr. Jeff Biernaskie). If you watch the CBC news piece on him they state these are 'early days and might take 5 years to know if it will work' Heres the video: http://www.cbc.ca/player/News/Canada...ID/2633667761/
Pay close attention, both the reporter and that whig seller both make a laughable statement that its 'not that far away'. Also notice how male pattern baldness patients are downplayed and the focus is on chemotherapy patients... the problem with that is that hair grows back after chemo, so really, its a temporary issue. There's very little respect that we as bald men get, we're essentially a joke to everyone.
With these laws, wasn't it possible to get a release DURING the phase 2 trials? I cannot wait till late 2016 or 17 at all, I'm already down to my last phases in diffuss thinning before My hair starts to looks completely transparent.
What would you guys suggest? Go for a FUE or wait on this thing and Histogen? I don't want to get a FUE (which can look unnatural) and then Replicell comes out but I squandered my chance to get my natural hairline back with a FUE. For example, hello, why haven't you considered a FUE?
12-19-2014 10:53 AM
Hairismylife
Quote:
Originally Posted by inbrugge
With these laws, wasn't it possible to get a release DURING the phase 2 trials? I cannot wait till late 2016 or 17 at all, I'm already down to my last phases in diffuss thinning before My hair starts to looks completely transparent.
What would you guys suggest? Go for a FUE or wait on this thing and Histogen? I don't want to get a FUE (which can look unnatural) and then Replicell comes out but I squandered my chance to get my natural hairline back with a FUE. For example, hello, why haven't you considered a FUE?
Have you tried Ru?
12-19-2014 11:39 AM
hellouser
Quote:
Originally Posted by inbrugge
With these laws, wasn't it possible to get a release DURING the phase 2 trials? I cannot wait till late 2016 or 17 at all, I'm already down to my last phases in diffuss thinning before My hair starts to looks completely transparent.
What would you guys suggest? Go for a FUE or wait on this thing and Histogen? I don't want to get a FUE (which can look unnatural) and then Replicell comes out but I squandered my chance to get my natural hairline back with a FUE. For example, hello, why haven't you considered a FUE?
Similar reasons as you actually. I'm worried that implanting follicles to the recipient area (hairline and elsewhere) via hair transplant will compromise existing miniaturized follicles already there.
The question is: does a hair transplant destroy those follicles or not? Only way to find out is to take an indepth look at a man thats already undergone an HT and see whats left.... Dr. Cotsarelis should be able to do this as he's already confirmed that follicles never actually die, the cells remain but the follicles are quite small.
12-21-2014 03:00 PM
inbrugge
Thanks, hello. I'm losing patience each day as my hair gets thinner and thinner. I might just take the plunge on a FUE, but now there's a little new hype around stem cell injections and PRP's again.
Quote:
Originally Posted by Hairismylife
Have you tried Ru?
Yeah, I did for a couple of weeks on low dosage. Got sexual sides down there, freaked out and quit. LOL
Then I was on Topical Fin, with much more moderate sides down there BUT with some gyno, so I had to quit that as well. Still waiting for the gyno to dissappear.
12-21-2014 04:16 PM
Jazz1
Quote:
Originally Posted by inbrugge
Thanks, hello. I'm losing patience each day as my hair gets thinner and thinner. I might just take the plunge on a FUE, but now there's a little new hype around stem cell injections and PRP's again.
Yeah, I did for a couple of weeks on low dosage. Got sexual sides down there, freaked out and quit. LOL
Then I was on Topical Fin, with much more moderate sides down there BUT with some gyno, so I had to quit that as well. Still waiting for the gyno to dissappear.
You not lowered the finesteride dosage topical? I think you need a very very low dosage topical.
You not lowered the finesteride dosage topical? I think you need a very very low dosage topical.
Bro I think I'm done with topical fin because it made my gyno worse. I'm now 3-4 weeks off it and the gyno still hasn't dissappeared (it gets better some days, then other days it gets worse again).
I hope it will go away completely since I was only on topical fin for 2-3 weeks. I ordered some RU, if my gyno goes away 100% I will try that. If not, then it will be a FUE or Replicell if it comes through in the next year.
Any news is great news of course but I am very disappointed with their timeline. They initially announced the phase 2 clinical trials would start in the first half of 2014. Then it became the second half of the year, and now we are looking at starting in 2015.
WTF!!! We have already lost 12 months out of 39 with these delays. That's 1/3 not to mention we don't even know if they'll start on time.
Get it together David Hall!! :mad::mad::mad::mad:
01-05-2015 03:11 PM
hellouser
Quote:
Originally Posted by Thinning87
Any news is great news of course but I am very disappointed with their timeline. They initially announced the phase 2 clinical trials would start in the first half of 2014. Then it became the second half of the year, and now we are looking at starting in 2015.
WTF!!! We have already lost 12 months out of 39 with these delays. That's 1/3 not to mention we don't even know if they'll start on time.
Get it together David Hall!! :mad::mad::mad::mad:
And yet, when I make the same complains, everyone becomes an apologist and says 'just be patient!' or some other nonsense.
01-05-2015 09:16 PM
macbeth81
We will have to wait a long time. They keep delaying the trials and even once completed, they won't have the money to go to Phase III without a partner.
They state they are using a high/medium/low dosage, but if they are no higher than the Phase I/IIa dosage then don't expect much better results. They are also only testing two treatment frequencies. With exception to the two-treatment group to determine if results are compoundable, this seems like a waste of time/money.
Hopefully Shiseido can do a more thorough study and get this to market.
Looks like we are screwed for the foreseeable future. Maybe CB-03-01 and Bimatoprost by 2020 but those are just treatments. Histogen got raped by the lawsuit, so who knows. SM04554 is moving along and wasting no time without a peep, hopefully they have something. Either way the next five years of our life lost. Then considering it took 15 years for RepliCel to go from research to this point, it is going to be a long time.
01-05-2015 10:58 PM
hellouser
Quote:
Originally Posted by macbeth81
Then considering it took 15 years for RepliCel to go from research to this point, it is going to be a long time.
Which is what I really don't understand. They had the research/treatment method done 15 years ago... so what were they doing in the last 15 years? Why does this ALWAYS happen? Some new breakthrough comes out into the mainstream and the doctors/researchers got it figures out and then they say 'yeah, within 5 years!' but in reality its 15+ years? What the hell is going on?
01-06-2015 07:23 AM
Thinning87
Quote:
Originally Posted by macbeth81
We will have to wait a long time. They keep delaying the trials and even once completed, they won't have the money to go to Phase III without a partner.
They state they are using a high/medium/low dosage, but if they are no higher than the Phase I/IIa dosage then don't expect much better results. They are also only testing two treatment frequencies. With exception to the two-treatment group to determine if results are compoundable, this seems like a waste of time/money.
Hopefully Shiseido can do a more thorough study and get this to market.
Looks like we are screwed for the foreseeable future. Maybe CB-03-01 and Bimatoprost by 2020 but those are just treatments. Histogen got raped by the lawsuit, so who knows. SM04554 is moving along and wasting no time without a peep, hopefully they have something. Either way the next five years of our life lost. Then considering it took 15 years for RepliCel to go from research to this point, it is going to be a long time.
I have to say I am kind of optimistic about Replicel though, in terms of product. So far we have only seen results at less than the 2 year timeline needed for a hair follicle to grow hair. Sheiseido's investment is a good sign, if it is true that they have been shown these results as Spencer suggested in a podcast a while ago I believe.
Now, that doesn't necessarily mean it is it, but we might have a positive surprise.
As to timelines, all we can do is hope the Japanese researchers can count on more resources to get to market with this thing if it turns out to be as good as I think it will be.
01-06-2015 01:47 PM
PinotQ
Quote:
Originally Posted by Thinning87
I have to say I am kind of optimistic about Replicel though, in terms of product. So far we have only seen results at less than the 2 year timeline needed for a hair follicle to grow hair. Sheiseido's investment is a good sign, if it is true that they have been shown these results as Spencer suggested in a podcast a while ago I believe.
Now, that doesn't necessarily mean it is it, but we might have a positive surprise.
As to timelines, all we can do is hope the Japanese researchers can count on more resources to get to market with this thing if it turns out to be as good as I think it will be.
If you haven't read the posts of Dr. Aaron Gardener on this forum regarding the multiplication of DP or DSC cells it is illuminating. The major issue as I understand it is culturing these cells into the millions over numerous passes without losing their inductive characteristics. I believe Dr. Gardener's group has been successful in restoring up to 60% of the characteristics of DP cells using 3D cultering. However, they had no success in restoring the characteristics of DS cells. Here is a quote from one of his posts:
"So I'll summarise our workings on the DS:
• Freshly isolated DS is as competent as the DP.
• The DS acts as a reservoir for DP cells during the morphological changes of the hair cycle, see: http://www.akclinics.com/images/regrowth-cycle.jpg
• In our hands 2D expanded DS do not retain inductivity.
• In our hands 3D culture of DS does not restore inductivity.
• We are attempting to restore inductivity in the DS by increasing expression of DP specific genes in the DS, but have currently not had any success.
• This is designed to help us identify key genes so that we can hopefully in the future use dermal fibroblasts, a much easier to isolated and expand population than DS or DP. See the Rendl labs work, they are attempting to go direct from DF already, very exciting work.
As for Replicel I honestly don't know as I've not seen any data. I know they reported the findings of their clinical trial in Japan but I've not seen the data myself. I would imagine they have the same issues as other and other groups, but, they may be doing something different that has allowed them to get past this. Again, it will be very interesting to see the findings and I think it's a very valid approach as a whole but I don't know the specifics."
Does anyone know what happened with Dr. Gardener? His posts on this forum just stopped cold.
01-06-2015 06:38 PM
FearTheLoss
What I want to know is, what ever happened to the interview between David Hall and Spencer that we were supposed to be able to see at some point? Also, could we please get Spencer to interview histogen again?
01-06-2015 09:57 PM
Thinning@30
Quote:
What I want to know is, what ever happened to the interview between David Hall and Spencer that we were supposed to be able to see at some point? Also, could we please get Spencer to interview histogen again?
This. Why tell us that you have some information but can't share it?
I also want an official update on Histogen. There seems to be so much misinformation out there right now. It's not clear how many trials they still need to do before commercial release. Their website still lists pan-Asian approval in 2014 with an expected U.S. release in 2015. Obviously way out of date at this point.
01-06-2015 10:28 PM
FearTheLoss
Quote:
Originally Posted by Thinning@30
This. Why tell us that you have some information but can't share it?
I also want an official update on Histogen. There seems to be so much misinformation out there right now. It's not clear how many trials they still need to do before commercial release. Their website still lists pan-Asian approval in 2014 with an expected U.S. release in 2015. Obviously way out of date at this point.
Histogen's CEO stated that they are planning to release in Asia immediately after phase IIb finishes..however, the question is, will they get the funding to start phase IIb?
01-08-2015 06:32 AM
brocktherock
What I want to know is how much does Sheseido have to do to get it approved, Relicel stated that their trial in Germany will last 36 months but in japan they can release it DURING phase 2. If they are gonna blow millions to get it out sooner in Japan then I think they will try to be more aggressive. Ever since shesiedo came into the picture they seem to be very upfront and proud for a team that already has funding. I think they have something and want to win the race.
01-08-2015 10:14 AM
efedrez
Quote:
Originally Posted by brocktherock
What I want to know is how much does Sheseido have to do to get it approved, Relicel stated that their trial in Germany will last 36 months but in japan they can release it DURING phase 2. If they are gonna blow millions to get it out sooner in Japan then I think they will try to be more aggressive. Ever since shesiedo came into the picture they seem to be very upfront and proud for a team that already has funding. I think they have something and want to win the race.
I think all the conditions are there for Sheseido to really make a big difference, they only need to start phase 2 once and for all so we will really start counting the days before we can see results
I just hope there will not be any further delays
01-11-2015 05:56 PM
Bald Russian
Quote:
Originally Posted by Recidive
the goal of commercializing this technology by 2018.
To say that i'm dissapointed means to say nothing.
We all expected so much that japanese could make it faster with their new law...
All about money...
As i remember that tsuji-lab promised hair at 2020 but their site is down - www.tsuji-lab.com
No news from follica...
I just wonder, why replicell cant offer a their procedure to volunteers for money, of course with signed contract where volunteers are cautioned about all risks?
01-22-2015 10:34 AM
brocktherock
Quote:
Originally Posted by efedrez
I think all the conditions are there for Sheseido to really make a big difference, they only need to start phase 2 once and for all so we will really start counting the days before we can see results
I just hope there will not be any further delays
They are having another presentation on the 26th and on their website announcing this news it still says Q1 2015 for both trials. The presentation on the 12th showed that the cells grow from 5 to 8 weeks. Im very excited because they aren't dick dancing like follica, they are backed by a huge company and are giving details that very inspiring.
03-11-2015 12:08 PM
KO1
Replicel is so incompetent. Is shiseido using a diff technology from Replicel or just deploying it in a larger scale? I didn't realize they were running parallel trials.
Replicel used to be the second rate outfit compared to aderans, but with perhaps Shiseido's backing, they can do better work.
03-11-2015 09:24 PM
macbeth81
Quote:
Originally Posted by KO1
Replicel is so incompetent. Is shiseido using a diff technology from Replicel or just deploying it in a larger scale? I didn't realize they were running parallel trials.
Replicel used to be the second rate outfit compared to aderans, but with perhaps Shiseido's backing, they can do better work.
Shiseido has not released any details regarding their pending trial. I am hoping they enhance the protocol, but don't know. I have mentioned before that Shiseido has done prior research and had a patent regarding the use of DS cell culturing. Shiseido will also be presenting on March 20th, topic being "Use of human induced pluripotent stem cells for the generation of hair inductive dermal cells". Maybe they know how to culture DSC cells more effectively.
RepliCels delays are becoming annoying. Phase I/IIa results were poor. One of them need to start trials and see if they can improve or not so we can put this behind us. In the end if this even works, RepliCel is years away from USA/Europe. Therefore ideally Shiseido starts ASAP.
Shiseido has not released any details regarding their pending trial. I am hoping they enhance the protocol, but don't know. I have mentioned before that Shiseido has done prior research and had a patent regarding the use of DS cell culturing. Shiseido will also be presenting on March 20th, topic being "Use of human induced pluripotent stem cells for the generation of hair inductive dermal cells". Maybe they know how to culture DSC cells more effectively.
RepliCels delays are becoming annoying. Phase I/IIa results were poor. One of them need to start trials and see if they can improve or not so we can put this behind us. In the end if this even works, RepliCel is years away from USA/Europe. Therefore ideally Shiseido starts ASAP.
It will be interesting to see if Shiseido can find a way to retain inductivity when cultering DSC cells. I don't know if any of you recall but a very knowledgeable researcher, Dr Aaron Gardner, was posting on here for a time and while some of the research groups had been able to attain inductivity of DP cells of up to 60%, no one had been able to attain any inductivity for DSC cells......meaning the DSC cells lost all of their hair growing characteristics when cultered. Here is the link if anyone is interested: http://www.baldtruthtalk.com/showthr...ighlight=pgd21. Not sure why this thread went silent.
03-12-2015 07:31 AM
FearTheLoss
I emailed Shiseido asking when they are starting their trial and when they plan to release the product and here's their response:
"Thanks for contacting us. Regarding your inquiry, we are planning to start commercializing the project that related to safe and effective hair regenerative medicine for those who suffer from alopecia and thinning hair, in 2018. That is all we're able to tell you about this project now. Thank you very much for your interest."
03-12-2015 09:09 AM
Hairismylife
Quote:
Originally Posted by FearTheLoss
I emailed Shiseido asking when they are starting their trial and when they plan to release the product and here's their response:
"Thanks for contacting us. Regarding your inquiry, we are planning to start commercializing the project that related to safe and effective hair regenerative medicine for those who suffer from alopecia and thinning hair, in 2018. That is all we're able to tell you about this project now. Thank you very much for your interest."
2018…we must find something to 100% maintain our hair now because really think that Replicel can only bring back 1 norwood, given their poor phase1 result.
03-12-2015 09:27 AM
PinotQ
Quote:
Originally Posted by FearTheLoss
I emailed Shiseido asking when they are starting their trial and when they plan to release the product and here's their response:
"Thanks for contacting us. Regarding your inquiry, we are planning to start commercializing the project that related to safe and effective hair regenerative medicine for those who suffer from alopecia and thinning hair, in 2018. That is all we're able to tell you about this project now. Thank you very much for your interest."
Well that's certainly a much more direct statement than we are used to getting. Seems to assume they feel it works at least to some measurable extent over what we have now as I don't see much in the way of qualifiers in that statement other than the word "planning". Not sure how they are that confident 3 years out but it beats telling us it is rock solid effective in mice!
03-12-2015 10:09 AM
sascha
Quote:
Originally Posted by PinotQ
Well that's certainly a much more direct statement than we are used to getting. Seems to assume they feel it works at least to some measurable extent over what we have now as I don't see much in the way of qualifiers in that statement other than the word "planning". Not sure how they are that confident 3 years out but it beats telling us it is rock solid effective in mice!
I am pretty sure that they just stick to their statement they made in 2013 in a PDF, it said they want to bring it to market in a period of 5 years.
03-12-2015 05:35 PM
hellouser
Quote:
Originally Posted by FearTheLoss
I emailed Shiseido asking when they are starting their trial and when they plan to release the product and here's their response:
"Thanks for contacting us. Regarding your inquiry, we are planning to start commercializing the project that related to safe and effective hair regenerative medicine for those who suffer from alopecia and thinning hair, in 2018. That is all we're able to tell you about this project now. Thank you very much for your interest."
3 years... wow. in the hair loss world, thats actually soon given how incredibly poorly the past players like Aderans have done in regards to meeting deadlines AND making projections.
