I second that question. Whats your source for this info?
The information that the human trials should start in March 2019 is an email from Dr. Tsuji (see below). The information about the possible 1-year timeline for approval comes from the new Japanese government policy on review and approval of biological and medical treatments (see link I posted above about the Sakigake policy and a lot of other information all over the web…)
So japan adopted a new policy for their medical approval process which takes roughly a year. Sounds good. Wish USFDA had adopted a similar process. But I think the reason why they dont is that there are a lot of drugs waiting to be tested coupled with politics and economics thrown in.
This time next year I better be smiling upon reading that japan has already approved multiplication and is ready to sell it to sufferers which will compel me to buy a round trip ticket to go there.
I wouldn’t say it always takes a year, I’d say that it can take as little as a year.
I see. Lets hope it does take as little as a year in this case.
I have written off Replicel a long time ago already. It’s ridiculous they are putting this off for so long because of some argument between Replicel and Shiseido. If they were serious about this product or if the trial results were impressive, they would have found a way to bring this to the market by now.
Facts!
“While the Company’s RCH-01 for hair loss due to androgenic alopecia may be launched in Japan much earlier if Shiseido decides to do so, current planning anticipates the potential for all four products to be on the market in Japan by 2022.”
https://www.replicel.com/news/replicel-reignites-its-first-in-japan-strategy
Oh boy… here we go again. I knew there was a catch to this. 1st they said it’d be ready by 2019… then 2020… now 2022. Trust me, this is gonna be ready by the time some of us are long gone from the earth. Lost my faith in this a while back.
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I told you so ! I have written off Replicel a long time ago already.
No, no no… we’re not talking about replicel. We’re talking about follicular multiplication in japan.
Be careful not to mix up “Replicel” with “follicular multiplication in Japan”, which also includes Dr. Tsuji/RIKEN. I think it would be pretty stupid to assume that whenever Replicel fails, Dr. Tsuji will fail for the same reasons. If you’re getting the two confused, you don’t understand the differences between the two.
Well, tomorrow (Sunday) is the last day of March 2019, and in the most recent RIKEN update I received on 29 March, there was no mention of Dr. Tsuji’s stem cell hair project …
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I don’t know why some of us think that we will have a new treatment next year. Tsuji’s work sounds promising, but I doubt they can stay on target and have a commercial product next year.
Even though the Japanese government has streamlined the approval process, it is still unrealistic for Tsuji to start human trial in Mar 2019 and to have a commercial product in one year. I will give it 3 years , probably 2022, if all goes well.
I think you are absolutely right. Once marketed in Asia it could find quick approval in the US. And that makes sense because the procedure utilizes your own cells so HT doctors will scream (1) it’s available in Asia and (2) the hair germs come from the person’s own cells so it’s basically an auto-graft the same as a HT.
And the FDA might give it a green light quickly rather than seeing American HT specialists lose a lot of business to Asian HT specialists.
I remember reading about this aggressive approval process in Asia when it was first made law. Back then is when I think I read that a cell-based treatment could hit the market after it’s first successful human trial. But I really can’t remember for sure anymore because that was a few years ago.
You’re definitely not going to have to wait 3 years because that’s how things already were before the new policy. So whatever the new policy is, it’s faster than the old policy. So the new policy is either that the treatment can be marketed after the 1st trial is completed or after the 2nd trial is completed. My best recollection is that it’s after the 1st trial is completed but like Roger-that said perhaps some could be marketed right after the 1st trial but some may take until the 2nd trial is completed, or somewhere in between. I’ll try to find an article about it from back when the news first broke.
Here’s a link to an article about the speedy Japan approval process. And below the article I posted an enlarged flow-chart from the article that shows how it would be possible for a treatment to get to market after phase 1 trial completes
http://blog.fisherbioservices.com/cell-therapy-clinical-trials-and-the-mad-dash-to-japan
@jarjarbinx That’s great, but here’s what I’m worried about.
If Dr. Tsuji now says he expects clinical trials to start “next year” (meaning 2020), that could literally be any time next year.
Worst case scenario under that timeline, which may actually happen, is that the clinical trials could start at the very end of 2020. Let’s say they start in Nov. 2020.
Then we have to give them at least 1 year to actually conduct the clinical trials. So in that case they’d finish in about November 2021 (assuming the trial goes 1 year. It might actually go more than that, but it won’t go less than that.)
In that case, give them a few months to analyze the results and compile a report, and finalize their application for approval. Let’s say they submit the application in Feb. 2022.
Then we have to give the Japanese government agency most of a year (at least) to review the results and make a decision.
That brings it to the beginning of 2023. Let’s say sometime in the first quarter of 2023.
That puts approval at about 4 years from now.
Granted I’m starting out with a worst-case scenario for the start of trials (the tail end of next year).
But everything else in my timeline is predicated on the assumption that NOTHING else goes wrong in the run-up to the trials, the actual trials, or the analysis and approval process.
My big worry is that if everything they’ve said in the past (including what they’ve said to us in our most recent Q & A with them) then I don’t think it makes a lot of sense for them to need to add another year to the timetable. After all, in our last Q & A with them they were pretty convincing that they had all of the issues resolved. And yet now there is a 1-year delay for some reason. I’m worried that the 1- year delay means they didn’t really have all of the bugs worked out. If that’s the case then they may not be ready to start clinical trials in 1 year and there could be more delays. I’m worried that maybe they haven’t solved the inductivity problem after all or maybe they can’t produce
young hairs with lots of growth cycles with cells that come from older follicles. I’ve always been concerned that since there are a limited number of cycles programmed into each follicle does that mean the same is true for the cells of each follicle? And if that’s the case doesn’t that mean that if you use old cells to start with then your new follicles (that you will have paid 10s of thousands of dollars for) may only last a few cycles. And the cycles may be short.
In other words, I think they may have to turn the clock back on the cells before culturing them.
I think it’s now possible to turn the clock back on cells but I think that turns them into iPS cells and then you have different issues to deal with.
I think that when they turn back the clock on cells they maybe have to go all the way back to iPS cells. I don’t think they can turn old hair cells back into young hair cells again.
Do you know if that’s doable?
I believe the inductivity problem doesn’t exist in Tsuji’s method. As far as I know inductivity is only a problem with methods that try to “induce” existing miniaturized follicles into terminal hairs, or induce new follicles to grow, by injecting separated cells. With Tsuji’s method there is no induction because the follicle is already formed outside of the body. There’s nothing to induce - the work has already been done. Therefore the deficiency that cultured DP cells have with inductivity is not a problem.
As far as the number of cycles, I think Tsuji’s follicles will have about the same number of future cycles as transplanted hair. Why is that a problem? When a man gets a hair transplant, he is confident that the transplanted hair will grow out again and again over many cycles. Maybe not until he dies, but enough to keep a reasonable head of hair for a while. So I don’t see why the number of cycles left is a huge stumbling block.
Now, if they could use the technology in that article you posted to increase the number of cycles by a lot, then that would be all the better. But I think that’s a big leap in technology that will happen well after Tsuji is done with his current project.