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Replicel & Dr. Tsuji stem cell hair multiplication Update 2019


#16

Wow!! Damn good news. About time too. But the problem with this is the human trials can last a while. On top of that theres a drug approval process which will take more years I assume.

In other words this wont be ready to the general public by 2020. Most likely 2030.


#17

Under Japan’s new SAKIGAKE approval pathway, approval times for drugs and biological products (like cell therapies) is supposed to be much faster… Here’s a summary of the Sakigake pathway:


#18

So much faster than USFDA. When do you think we can realistically see this to market?


#19

I think it’s possible, if the trials go well, that we could see this on sale in the market in Asia within 2-3 years, maybe less.


#20

It’s my recollection that these types of cell-based therapies are supposed to be marketable after the successful completion of phase 1 (ONE) human clinical trials. Further testing would have to continue but the product could be sold to patients after phase 1. I believe that if the trial starts in March 2019 then the product could hit the market in Japan as soon as late 2020.


#21

My recollection is that the right cell-based treatments can hit the market in Asia after the first human trial but the testing also has to continue.

If it starts human trials in the next few months then it could almost reach the market in America in 3 or 4 years but it could hit the market in Japan in 2020 IMHO.


#23

Yes, and also while approval in the US will take longer than in Japan, for the Tsuji procedure (and anything similar) there will also be behind-the-scenes pressure by the HT industry to approve it.

Normally we can be assured that the HT industry is pressuring the FDA to be very skeptical of anything that would compete with HT, and to take a long time reviewing anything like cell-based alternative treatments, but in this case it will have to be regular HT surgeons who administer the treatment. They will have to license the treatment somehow from Dr. Tsuji and RIKEN, so it will be very popular with HT docs. I believe they’ll push for the FDA to approve it as quickly as possible.


#24

Someone logged into my account yesterday and edited my post, changed the Thread title. :unamused:
Was that you Mod? Not very cool.


#25

The thread has morphed into a discussion about Dr. Tsuji’s research, so your thread title was revised to reflect that. No other changes were made other than that.


#26

kinda foul


#27

Where did you get the idea that if trial starts in Mar 2019, then it could hit the market in Japan in 1 year’s time?


#28

I second that question. Whats your source for this info?


#30

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…)


#31

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.


#32

I wouldn’t say it always takes a year, I’d say that it can take as little as a year.


#33

I see. Lets hope it does take as little as a year in this case.


#34

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.


#35

Facts!


#36

“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


#37

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.