Report from Japanese side of Replicel - stem cell law in force at last

[Thinning87]

Last news for Replicel : http://www.replicel.com/newly-releas...tern-baldness/

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!!

[hellouser]

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!!

And yet, when I make the same complains, everyone becomes an apologist and says 'just be patient!' or some other nonsense.

[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.

[hellouser]

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?

[Thinning87]

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.

[PinotQ]

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.

[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?

[Thinning@30]

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.

[FearTheLoss]

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?

[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.

[efedrez]

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

[Bald Russian]

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?

[brocktherock]

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.

[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.

[macbeth81]

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.

http://www.replicel.com/replicel-life-sciences-in-japan-for-key-industry-meetings/