Shiseido Regulatory Path Update
After I shared an update about a potential announcement time frame for Shiseido a few weeks ago, I read a few queries from readers who wondered if a Shiseido market release would be available to everyone in the world. Today, I received more positive news from a credible source to help clear things up.
Once again, my gracious source is Lee Buckler, CEO of Replicel who owns the RCH-01 technology and licensed it to Shiseido. Lee believes there is no limit to the number of patients who can receive a cell therapy on a conditional approval, but he also divulged even better news, read carefully:
There you have it. Shiseido is aiming towards full commercialization in Japan. This still does not tell us the efficacy of RCH-01 or if the therapy will be commercialized, but it is great news to hear. Things are lining up now for that pivotal late 2018 announcement.
Posted in Lee Buckler, Replicel, Shiseido
What’s the difference between the ASRM pathway and approval by PMDA?
Other than the fact one is conditional and the other is full approval, don’t know.
One onvilves whispering to cause brain tingles and relaxation….
Sorry… I couldn’t help myself.
Amazing news! Thank you
I am wondering whether he forgot to mention that “with this full commercialization, it gonna take additional xx years” ?
I don’t believe it would be plural years at all.
Yup, hope I am wrong and you are right. Somehow, I trust the Japanese 🙂
Hey ADMIN, I am very glad about your question to Lee. Thank You very much!! But now I have to do my Research how much time the ASRM pathway will need…
The actual Lee Buckler has said he believes is very similar timeline.
One would need to make multiple trips to Japan if I’m not mistaken, cell culturing and multi injections? I’d be the 1st to sign up and while I’m fairly well off, it may be cost prohibitive.
Thank you the real Lee Buckler!
We need to know the effectiveness of the therapy and the safety of this method. Without this, only a madman can take such a stupid step.
You’ll find out in a couple of month when Shiseido publishes their phase 2 results. Doesn’t this mean that if effective and safe, shiseido has the option to fully commercialize it to everyone in Japan? Meaning, all we need to do is just buy a plane ticket?
Yes
Do you think this treatment will work for ppl have scarring from previous hair transplants??
It should grow through any scalp area which is not scar tissue.
Please see my earlier comment…unless Joseph knows something different, it will be buy plane tickets…not a single ticket, unless you plan on living there for a while. Cell culturing and multi injections if I’m not mistaken.
Since this is cell multiplication, is there any chance of getting cancer or sort of things ?
Just to have a little fun with you, do you think a billion dollar corp will put a product on the market that has chance of that kind of adverse event? 😉
Phase I showed no risk for cancer. It was conducted by a very famous Dr. (which name I don’t recall). It was a 5 yr study.
admin will this therapy immunize the remaining hair or will it create new follicules and what about the density ?
Thanks for your efforts thumbs upp
It’s stem cells. You take a resistant dht hair follicle from the back of your scalp, multiply it by “ex. 1000” and it basically works as a hair transplant, except now you have endless of hair, i.e. thick density. It’s not a cure per say in regards that it reverses hair loss or stops what you have remaining. But the end results will be better than “normal hair” as you can add as many as you want.
I thought that is what Riken are working on (?), which is still some way off. This is based on a replicating cells in a growth medium and then injecting into the scalp. No hair transplant (as would be the case with the Riken approach where new hairs are cultivated). See this; https://www.youtube.com/watch?v=cCe5mg7X6zg
Has there been any announcement of Shiseido when the Commercial Launch is targeted? I think only RepliCel has assumed a possible Launch of RCH-01 in 2018…
Replicel is in partnership with Shiseido and invented the product they are using….
Also Replicel has not recently assumed possible launch of RCH-01 in 2018, they have assumed an announcement from Shieido estimated in Sept/Oct 2018
I read some where that says since Replicel broke the promise by not carrying out phase 2 by themselves, Shiseido will no more share the info, such as plans, reports, trial datas, with Replicel anymore. Is it true ?
[Off topic] I read your tweet regarding the anonymous claim of Fidia photos that are very positive, have you managed to get any of those mentioned photos ?
Many thanks
I don’t know the first answer, yet I doubt the relationship is that severed, otherwise how would Lee have any clue as to Shiseido’s plans? (additionally please always provide a source or link when sharing similar hearsay) Let’s do our best to think reasonably. 🙂
I have not received any other photos. Fidia has shown they are going to announce things on their terms and are quiet until then.
Shiseido claimed Replicel breached the agreement by not launching their own study in tandem with Shiseido’s. This was due to financial constraints. However, no conflict resolution was triggered or terminated so the deal remains intact. As such, Shiseido is still obligated to share the data. Fingers crossed.
Not only would this be great for the scalp but maybe it could be an option for us beardless lads ?
#Babyfacebalding
Admin, will the announcement from Shiseido in Sep/ Oct be about the result of RCH-01?
If the result is positve, when will be the market launch in Japan and in Europe? Months, or years?
We wait and see.
Hi, can you please ask Lee for estimated time to relase the RCH-01 in europe after it will be released in Japan by Shiseido?
There can’t be an estimated release until more trials start, which they have not at this time. I believe that if Shiseido has positive results it will create enough funding for Replicel to run all of its trials. For now, we can say it would be years away.
Shiseido is a global player, possibly if the trial are a success they might seek to cut a deal for worldwide rights. At this early stage they could be just dipping their toes in the water.
Sure, Replicel/Shiseido is just semantics. Europe/Australia/US still need further trials to enter market though.
Just buy the plane ticket and don’t bother waiting extra 5 years 🙂
As I understood on this therapy is not a single injection but it has to be continued for several months and several injections. That means is not enghout to bay a single ticket. Am I right?
So, from what I realized until October, the results come out right?
If the results are feasible, do we still have to wait years for treatment in Japan?
I thought the treatment could be done by the end of 2018 in Japan and whoever wanted to go to Japan to do it. I finally got it wrong, is that it?
Piotr, I’ve bought this up two times in this thread, people may want to ignore that this is unfortunately probably the case. Either multiple trips or an extended stay that will encompass many months. Add that to the cost of the treatment and it will be out of reach for the great majority of people who live outside of Japan. Maybe Admin can get his Bro Lee Buckler to comment? 🙂
The way it’s supposed to work is they take a sample from you and multiply that amount by x1000 for example, which takes a few months if memory servers me right, and you have to return to have them re-inserted. Whether that requires multiple injections and the time period between them I’m unaware of but one can only speculate.
If the results are feasible, based on the above article, Shiseido are allowed to market it as soon as the results comes out, if proven safe and efficacy (Japanese laws). Consider it your vacation plans 🙂
HEY off topic…did anyone ever get decent results for REBOOST? What happened with that!?
I understand what you’re saying. People will have to make it happen or not. Let’s stay friendly.
Thanks for commenting and reading.
Amazing news! Thank you
HI Admin,
I saw the comment regarding hair transplants and the efficiency of the treatment on scar tissues. Why don’t you think it will work? Do you think the riken technology would work on the skin where hair has been transplanted? Thanks!
All I said was I thought the injections of RCH-01 would theoretically be able to sprout hair in the scalp anywhere but scar tissue. Hair transplants areas contain dots of scar tissue, but are not completely covered by scar tissue. Hopefully Riken works too.
I could be wrong, but I recall reading an article a couple years ago about Acell. The claim was that a surgeon could remove transplant scars and then fill it in with Acell, which would allow for hair transplants to grow. Does anybody remember this?
The efficacy of Acell does not work quite like that. There is still scarring with Acell, it’s just a little less scarring and the color is a little closer to normal skin tone.
If you have a failed hair transplant for instance, as far as I know, good surgeons can transplant just another transplant in. So they put in the punches our grafts, which are follicles? I would think then that if you inject follicles on the transplanted skin it should also work? Would just be my line of reasoning
Hi Admin,
Let’s say if the result positive in October which means they will release by end of this year begging if 2019? Or we have to wait another 5 years ?
IF result was positive, my guess is market release by end of 1st Half 2019.
The only thing you’d have to consider is a massive queue line to get the treatment done, granted everyone in the world would want this treatment. They’ll take a sample and you’ll have to wait at least 3 months for it to be “multiplied”. But yes, market release would be asap to reap the benefits of being the first company in the world to have a proper “cure”. Just gotta hope it works and it’s easy to book a time 🙂
I don’t know if this is a dumb question or not. But say RepliCel works and cures hair loss for good. Does that mean the gene “mpb” goes away and will not be hereditary anymore.
Hello, I’m sorry if the question has already been asked : but if you have a hair transplant, will this new technology work, or it’s a bad idea ?
I ask you because I hesitate to do a transplantation, and if this technology comes soon, it’s a bit stupid not to be patient
And second question : can we have a price idea ?
Thank you verry much
Hi, thanks for reading. The short answer is no one seems to know that answer definitively because no one has had the opportunity to try it in their transplanted hair. Nothing definitive on price has been shared either. I could guess and say $4,000.
No you are not altering genes you are cloning the cells that make up a hair follicle and reinfecting those cells back into your head. Its like a new type of hair transplant. i’ve been investing in Replicel. Lets hope this product takes off!!
hi admin, I hope you’re well! Question – as we get closer to the date, i’m wondering – has Shiseido ever said anything? I just can’t wait to hear something positive after the awful telogen effluvium (already have AA) i’ve had this year : ( xx
Thanks for kind words, same to you. Shiseido has not said anything recently.
Dear @ADMIN,
after asking SHISEIDO about the release of the RCH-01 results, I got this answer:
„Thank you very much for your interest in regarding“hair regenerative medicine
technology (RCH-01)”.
We are sorry to inform you that we are unable to meet your expectations.
This research is not conducted by us only. It will be announced from medical institutions, not from Shiseido.
Your kind understanding will be highly appreciated“
Can you please tell us what Shiseido has meant with „medical institutions“?? Which medical institution will announce the results to us? I can not imagine that they mean RepliCel cause Lee Buckler said,that results will
Be published by Shiseido… maybe you can ask Lee again please!
They must mean the medical institutions that carried out their trials. Either way, we will have to wait until those institutions do release the results.
Thanks for sharing! I will share this further.
please contact Lee Bukler..
I am so angry. I was only waiting for October. But Lee Bukler betrayed me.
when are you supposed to update about RCH-01???
If and when there is news announced.
Do you think the results will be announced in October?
I don’t know to be honest
to be candid if they had results worth sharing we would have known by now.
k
This is a perspective, not necessarily completely accurate. We’ll have to wait and see.
you truly have the best attitude, admin : ) x
I appreciate that, thank you.
news?
Yes, has been posted on the Updates. I recommend to all readers of Follicle Thought to check https://folliclethought.com/updates/ on a daily basis or similar for latest updates.
In short, we will not be hearing about Shiseido results until next year.
The news”This may or may not change if positive clinical data is announced in the coming weeks from the Japanese clinical study and/or if Shiseido announces an intention to commercially launch the product in Japan. We continue to press for a commercial solution with Shiseido that is mutually beneficial.”
I confusion，is that mean in Oct have a phase 2 or need wait to 2019?
We’ll have to wait and see I suppose
Hello, there is any update from Shiseido about RCH-01 ?
can’t wait for release date…
Please read the Updates page for the latest Shiseido news.
Already Wait 5year day by day check the news still don’t have a date,can tell lee give us a date. ,Facebook,email never reply…
Admin when will have news..,.,,,can u ask them ?
You think that if the results are good they will take it out in 2019 to the market, and what price do you think it will have? Some news ? a greeting