RIKEN Announcement: Succeeded in Developing Tech for HF Regenerative Medicine: Study to be Published Feb 10

[MeDK]

If they do fast track in Japan (phase 2 commercial release), they still need proof of concept in humans first.

So what could be interesting is that is the succes criteria?

Show that a hair follow can grow? (of course)

But will the long term goal be to prove it can do more than one cycle? If that is the case, we are looking into MANY years of just phase 1.

So we could speculate in this is going to be an ultimate long phase for each (i can't remember if there is a limit to how long a phase can run)

 

[trialAcc]

Next step is to start clinical trials...in what? hopefully not mice again, maybe next step pigs? best case scenario they start human trials and rich people can participate after a specific time due to Japanese fast approvement etc

Clinical trials are in humans.

 

[trialAcc]

This board is really quite pathetic lol. People who wouldn't dream of being able to afford this treatment and zero knowledge of the clinical process just having tantrums.

I thought there was a minor chance that they conducted a phase 1 in secret as proof of concept, but in actuality that would have almost been worse then what just happened. No one in the scientific community would have embraced this technology if they didn't actually publish their pre clinical data. Now we have that, it can be peer reviewed and actual human studies can begin.

 

[Pls_NW-1]

So we already know the answer that we will have to repeat this every 5-15 years, so its not a permanent solution, yikes!

 

[frank33]

If they do fast track in Japan (phase 2 commercial release), they still need proof of concept in humans first.

So what could be interesting is that is the succes criteria?

Show that a hair follow can grow? (of course)

But will the long term goal be to prove it can do more than one cycle? If that is the case, we are looking into MANY years of just phase 1.

So we could speculate in this is going to be an ultimate long phase for each (i can't remember if there is a limit to how long a phase can run)

Probably to be able to grow thick enough, pigmented and natural looking hair, and to confrm safety. I think long term (+5 years) "durability" of HF will not be discussed much.

 

[trialAcc]

If they do fast track in Japan (phase 2 commercial release), they still need proof of concept in humans first.

So what could be interesting is that is the succes criteria?

Show that a hair follow can grow? (of course)

But will the long term goal be to prove it can do more than one cycle? If that is the case, we are looking into MANY years of just phase 1.

So we could speculate in this is going to be an ultimate long phase for each (i can't remember if there is a limit to how long a phase can run)

That's not what phase 1 is lol. Phase 1 is basically 95% based on safety, so you're looking at 12~ weeks to see that the body doesn't reject or try and attack the new follicles, that body toxicology is normal and finally that the follicles growth mimics native hair.

What you are thinking of is phase 3, however, as many have pointed out, Japan is weird and will commercialize things that have passed phase 2. Technically this can be fully available yet there will still be a few hundred men who are being tested on for efficacy.

 

[jan_miezda]

yes and they used completely human cells?

This board is really quite pathetic lol. People who wouldn't dream of being able to afford this treatment and zero knowledge of the clinical process just having tantrums.

I thought there was a minor chance that they conducted a phase 1 in secret as proof of concept, but in actuality that would have almost been worse then what just happened. No one in the scientific community would have embraced this technology if they didn't actually publish their pre clinical data. Now we have that, it can be peer reviewed and actual human studies can begin.

 

[jan_miezda]

So we already know the answer that we will have to repeat this every 5-15 years, so its not a permanent solution, yikes!

that’s not true.... don’t spread this lie. They only monitored 3 hair cycles which are much shorter naturally in mice and all 3 cycles were observed

 

[Pls_NW-1]

Every 15 years 5000 dollar would be ok for me

I doubt it will be that cheap mh

 

[trialAcc]

So we already know the answer that we will have to repeat this every 5-15 years, so its not a permanent solution, yikes!

Again, not true. They don't test these things for infinite periods. Baselines for judging efficacy are established before the trials are already started.

In this case, Riken would have "aimed" to judge what happens for 3 cycles, and the data showed 80%. This won't be the final number either, could be better or worse in humans as they adjust the technology.

 

[werefckd]

80% regenerated for 3 cycles or more.
Mouse hair cycle about 3 weeks.
Human hair cycle about 5-7 years (according to that article).
If it translates to 3 human cycles, that's 15 years of hairs.
But as we've all seen before success in mice doesn't always translate to success in humans.

The big take away is that they've identified exactly what cells are needed for growth.. rather than just hoping dermal papilla or sheath cells alone will be sufficient to induce growth.

Nope. Allegedly they already had identified which those cells were since at least 2012.

The takeaway is that they presumedly solved the epithelial cell amplification problem IN MICE.

 

[Pls_NW-1]

that’s not true.... don’t spread this lie. They only monitored 3 hair cycles which are much shorter naturally in mice and all 3 cycles were observed

I mean, they said that the follicles are able to go just through 3 cycles, meanwhile native follicles/donor hair goes through a lot more, till we're dead.

 

[trialAcc]

yes and they used completely human cells?

Yep, basically a requirement for pre-clinical data. In this case I am a little surprised they didn't use a larger animal, though. Seems like a trial that would have very much benefited from pre-clinical efficacy on non-human primates.

 

[fearofthereaper]

People need to remind themselves that it was uncertain if Riken was still pursuing this technology a few months ago. Now they aim for clinical trials. Cheer up people, stop hating on the scientists that try to help us with this ffs

 

[trialAcc]

I mean, they said that the follicles are able to go just through 3 cycles, meanwhile native follicles/donor hair goes through a lot more, till we're dead.

No, they didn't say this. You're not understanding how this data is presented and obtained, and even in laymen's terms they openly said "3 or more".

 

[werefckd]

Yep, basically a requirement for pre-clinical data. In this case I am a little surprised they didn't use a larger animal, though. Seems like a trial that would have very much benefited from pre-clinical efficacy on non-human primates.

True but they couldn't since their company went bankrupt and they are now lacking the funds and the structure. Business wise they are almost starting from scratch again.

 

[Shush]

Yo chill out and wait the announcment. You guys trippin' too hard right now making your own stories and theories

 

[trialAcc]

True but they couldn't since their company went bankrupt and they are now lacking the funds and the structure. Business wise they are almost starting from scratch again.

Please show me a biotech startup that doesn't require funding for every new round of studies. Not a single one of these companies has money/revenue until they commercialize a product.

This isn't going bankrupt, and it isn't starting from scratch.

 

[werefckd]

Yo chill out and wait the announcment. You guys trippin' too hard right now making your own stories and theories

The announcement already happened. It was a small study on mice and now they want to start clinical trials but need money and a partner.

 

[MeDK]

That's not what phase 1 is lol. Phase 1 is basically 95% based on safety, so you're looking at 12~ weeks to see that the body doesn't reject or try and attack the new follicles, that body toxicology is normal and finally that the follicles growth mimics native hair.

What you are thinking of is phase 3, however, as many have pointed out, Japan is weird and will commercialize things that have passed phase 2. Technically this can be fully available yet there will still be a few hundred men who are being tested on for efficacy.

I do know what phase 1 is, it still have different timelines. And they still need to see for how long it works. Sure you can do a short period but if you are looking into for how long it works, then it makes no sense to do a short period. Its not a topical they are doing. So the effects could be different and show later.

If we use Replicel as an example for human trails, they did a check up at 6 months and 24 months. It would be beyond amazing that Riken did it at 3 months and closed phase 1