RIKEN Announcement: Succeeded in Developing Tech for HF Regenerative Medicine: Study to be Published Feb 10
- Thread starter pegasus2
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So they're planning to start trials within a year and they will last a year and a half? Followed by a broader trial where it is offered to trial subjects who apply?
Yeah, not really sure what this means "If this clinical study reveals its safety and efficacy, it can be implemented in society as a paid clinical study."
However, they said they'd start their trials within a year of receiving the necessary funding, not just within a year, so who knows how that'll go.
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You mean many hairs coming out from a single pore? I somehow can't understand this.
I think you're right, it would be the equivalent of a drug being commercialized in the USA after phase 2 due to orphan drug status but phase 3 continues on people who are just taking the drug because they need it. By the sounds of it they can start offering it after 1 trial.
I knew people would complain about the density. East Asians have an average density of 111 hairs/cm². The guy in that video has really fine hair. They can control the density meaning they can increase it for caucasians who have thinner hair strands with higher density. The density they are talking about is for Japanese patients, and it's significantly higher than normal Japanese density.
Edit: they are talking about conditional approval. They still have to follow up on patients, but they will be able to treat as many as they want.
Edit: they are talking about conditional approval. They still have to follow up on patients, but they will be able to treat as many as they want.
Normal transplant density at the front, maybe. It isn't achieved all over the scalp though.
If this could allow for unlimited hair to a max 120~ it would still be a successful innovation. Some people end up with 40~50 hairs per/sqcm on their crowns due to lacking donor. Anyways, they specifically said "normal human density", so I'm assuming they do not mean transplant density.
He took one look at this forum and concluded hair loss causes mental illness
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Lol you're insane if you think that unlimited grafts doesn't bring anything to you. The whole problem with transplants is the limited donor.
Commercialize is a broad term. One or two clinics in Japan offering this is "commercialization".
But yes, you are correct, and that's been my problem with Tsuji from the beginning. Stemson is already working on commercialization planning for scale, they've brought hair transplant surgeons onto the board and teams to develop the procedure and already have potential distributors/facilitators via Allergan. They've created multiple products to be able to get the procedure out more quickly to higher paying customers, etc.
What exactly has Tsuji planned, at all?
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Some pages ago there was a story about a bankrupt company (Kyocera?) that was going to scale up the whole thing, after that many lost hope etc, they had a plan, but the plan failed. Tsuji ain't the fastest guy.
Kyocera is far from bankrupt, and they are still working with RIKEN. It is Organ tech that was supposed to conduct the trials but went under. Who exactly is faster than Tsuji? Tsuji has been ready for human clinical trials since 2020, He will probably still beat Stemson to human trials, and almost certainly beat them to market.
They're probably going to use the MHRA ILAP pathway for their initial product while trialing the secondary one through the regular channels, that's how the pitch deck read to me anyways. I say they're on the market 1-3 years prior to Tsuji, without counting the commercial availability of later stage trials in Japan.
This is assuming the process actually works, of course.
I highly doubt they get turned down, but we'll see. This is the exact type of treatment a country like the UK wants to welcome in with open arms post brexit. They want to establish themselves as a new innovation hub after getting free of the EU restrictions.
True. I hope they do. We are waiting on Tsuji to get funding and Stemson to take advantage of ILAP. I just don't think it's going to take Tsuji much longer to get funding. I think middle of the year and then start trials first quarter next year. They said within a year of getting funding, which is probably closer to six months. That would put them at mid 2023 for market launch, which is going to be hard for Stemson to beat even if they do take advantage of ILAP in the UK.
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Yep Organ Tech, forgot the name, that's why I put a ? behind it and Tsuji didn't start yesterday, it took him 10 years to get to this point and we gotta see how much time will pass until this will be ready for a broad spectrum for people. So 10-15 years ain't the fastest ever, maybe for such a research it's a short period, but not fast.
"latest"... Do you wanna bet?
I see some hype around here. I hope that, whatever it is, this time the company succeeds.
Stem Cells/iPSCs, CRISPR-Cas9, 3D/4D bio printing open new tremendous possibilities in science, but they are all in very early stage of research.
I will never understand why companies who can grown 5 hairs gets 15-20 million dollars investments, but on other hand Dr.Tsuji is begging people to donate money, so he can continue with research...
I will never understand why companies who can grown 5 hairs gets 15-20 million dollars investments, but on other hand Dr.Tsuji is begging people to donate money, so he can continue with research...
It means that they must firstly proof and verify their technology through legit clinical trials.
I guess they have other techniques than mice to see how their technology will translate on humans