Histogen and Replicel : stem cell meeting on the Mesa

[Scientalk56]

Japan is pretty random, must be to attract partners.

What phase are they in NA? Phase IIb?

they badly slowed down two years ago, was so dissapointing, as it felt like this was a viable treatment option for us, not a cure at all, but something better than Minoxidil.

I think it will be phase IIb / III

In my opinion lets not look backward, but only forward

Plus Japan isn't a third world country.. so it's pretty good

[LMS]

Good stuff, I still have alot of faith in histogen personally.

[hellouser]

So basically histogen will be released in Asia within 2 years.

What is this timeline based on?

[joely]

When she says 100 more hairs, does anyone know over what space that is?

[comb0ver]

do we know how long their final phase trial is?

and then how long it will take them to bring histogen to market?

[Sogeking]

I think this has promise. It won't cure you but it is also viable to the diminishing returns as it was said by Dr. Naughton.
They are starting last phase in Japan beginning this year.

Remaining questions:
How long will the last phase last? I mean Replicel phase 2 is 3 years long. However I don't expect the last dosing trial to last this long. ALthough this could be normal phase 2 trial which is why they chose Japan (regulatory fast track in Japan).
Second question: this requires repeated injections which means staying in Japan for a longer period of time. How to pull this off?
And of course price...

After last phase ends i believe it takes some more months to bring it to the market although they have to find partners first...

@comb0ver

[macbeth81]

When she says 100 more hairs, does anyone know over what space that is?

Phase I/IIa trials used 8 injections, spaced 3mm apart, within a 1.2cm2 area. Would that be enough density to be cosmetic?

[sdsurfin]

I think either way it should be a good way to keep your hair. Probably nothing will be a good cosmetic option for guys who are already very thin, until they really nail the cloning. This is great news if the trial is happening, shideido should buy histogram too and combine it with replicel.

[hellouser]

I think either way it should be a good way to keep your hair. Probably nothing will be a good cosmetic option for guys who are already very thin, until they really nail the cloning. This is great news if the trial is happening, shideido should buy histogram too and combine it with replicel.

No reason why you couldn't do both procedures, one after the other. I wouldn't be surprised if cultured DSC cells would create nice terminal hair growing follicles WHEN supplemented with Histogen's growth factors AFTER Replicel's injections. We know that battling hair loss isn't a single pathway (DHT) as even the inhibition of that still causes further loss, so a multi approach is likely necessary (downregulation of DKK1, PGD2, DHT, etc) and upregulation of PGE2, etc. A similar approach MAY be necessary or beneficial by combining histogen with replicel.

[garethbale]

Pay close attention to what she says at 4:45

'So we're moving forward right now with the strategy to do our final clinical trial for approval in Japan starting early next year for male pattern baldness.'

I found this quote slightly ambiguous...

Did Gail mean they are moving to implement the strategy in early next year or the trial itself? If it's the strategy, the trial may not happen till later.

The fact that they have targeting Japan is great though, since Japan has its legislation to advance stem cell technologies at a quicker rate to the West.