Histogen show "cosmetic" results oct 2012 update

[hellouser]

we're kinda going in a circle here, but most reputable people say the next step is Phase III for histogen, they're gonna have to clarify it themselves.

at least part of it will be going into phase III, they are most definitely ahead of where aderans is(which hasn't updated in a year.)

Histogen is going to have to hurry up, Aderans is going to start Phase III trials soon (i think by February 2013 they should star Phase III). Their projected date of Q1 2014 of a commercial product would be quite possible if Phase III goes without any roadblocks.

[rdawg]

HSC going into phase 2 isn't a big deal, it's where aderans is at.

we're kinda going in a circle here, but most reputable people say the next step is Phase III for histogen, they're gonna have to clarify it themselves.

at least part of it will be going into phase III, they are most definitely ahead of where aderans is(which hasn't updated in a year.)

[yeahyeahyeah]

fair enough, whatever phase they're going into I'd like them to clarify for sure.

either way they are almost guarenteed to get approval on the next phase.

Edit: not to mention, have they even started trials in the US? i'd like info on that as it can take around 3 years to get approval down there.

HSC going into phase 2 isn't a big deal, it's where aderans is at.

[rdawg]

TBH, I think its likely to be Phase 2/3.

Not phase 3 for HSC

fair enough, whatever phase they're going into I'd like them to clarify for sure.

either way they are almost guarenteed to get approval on the next phase.

Edit: not to mention, have they even started trials in the US? i'd like info on that as it can take around 3 years to get approval down there.

[yeahyeahyeah]

here's the quote to clarify

TBH, I think its likely to be Phase 2/3.

Not phase 3 for HSC

[rdawg]

Hey guys,

I am pretty new here so I thought I should introduce myself. I'm a pharmacist with some experience in clinical trials. I just wanted to point something out that is a bit worrying.

As most of you may know, Phase I is the safety trial; Phase II is the "Dose-range finding" & "Efficacy trial" and Phase III is the "Long-term safety & efficacy study".

What's worrying to me is that Histogen's Phase I/II involved only 8 injections in one or two sites of scalp. Dr. Ziering's study involved 20 injections in one or two sites.

Upon completion of this study, they will move to Phase III to evaluate safety of the same concept in even larger population.

So, it will most likely be approved for a limited number of injections per session as its safety for higher doses has NOT been established!

That would really minimise how much growth you can achieve!

Cheers

here's the quote to clarify

Phase one was just the safety pilot, then they moved on to phase I/II, now it's the long phase III as they've already proven it works on a small scale and is safe. There is no point in doing another year of small-scale phase II when they've already proven it's been safe for 2 years.

[yeahyeahyeah]

It's still going into phase III, there is no I/IIb, a pharmicist in another thread clarified that.

They've done the pilot already which ended december 2011, then phase I/II(as they did it on 24 subjects) now phase III where they expand to hundreds. or at the very least phase II/III

I dont get it. How is this possible, and why is it saying phase 1 on the web site?

[rdawg]

http://www.clinicaltrials.gov/ct2/sh...istogen&rank=1

Condition Intervention Phase
Androgenetic Alopecia


Biological: Hair Stimulating Complex (HSC): phase 1
Device: Dulbecco's Modified Eagle Medium, DMEM : phase 2

It's still going into phase III, there is no I/IIb, a pharmicist in another thread clarified that.

They've done the pilot already which ended december 2011, then phase I/II(as they did it on 24 subjects) now phase III where they expand to hundreds. or at the very least phase II/III

[yeahyeahyeah]

This was phase II

http://www.clinicaltrials.gov/ct2/show/NCT01501617?term=histogen&rank=1

Condition Intervention Phase
Androgenetic Alopecia


Biological: Hair Stimulating Complex (HSC): phase 1
Device: Dulbecco's Modified Eagle Medium, DMEM : phase 2

[yeahyeahyeah]

Nope it was phase 1

[rdawg]

How can they get to phase 3 when they are not even in phase 2?

This was phase II

[yeahyeahyeah]

Btw guys these two pictures are from results at 5 and 6 months, so who knows what they'll look like at say the 1 year mark.

i'm interested in more pictures but overall still extremely positive.

with actual solid results, this means this goes into phase III soon(yes phase III), meaning a late 2014/early 2015 release in europe, which is quite close.

Not sure what they have to do for the states or whether or not they've even started a trial(can they do one simultaneously? can they skip right to phase II?)

but guess wise with it going through each phase, we're looking at late 2015, early 2016 for the states.

How can they get to phase 3 when they are not even in phase 2?

[rdawg]

Btw guys these two pictures are from results at 5 and 6 months, so who knows what they'll look like at say the 1 year mark.

i'm interested in more pictures but overall still extremely positive.

with actual solid results, this means this goes into phase III soon(yes phase III), meaning a late 2014/early 2015 release in europe, which is quite close.

Not sure what they have to do for the states or whether or not they've even started a trial(can they do one simultaneously? can they skip right to phase II?)

but guess wise with it going through each phase, we're looking at late 2015, early 2016 for the states.

[MoreCoffee]

I really hope we can start getting injections sooner then many are predicting and even more important is I hope iits safe!

[Night]

Try to compare the best clinical results (6 months) on propecia to 6 months on this...

Propecia's 'study' picture regrowth imo wasn't that great looking. I think real world had more IMPRESSIVE results. In my opinion this is exciting. It works, its obvious.

I can't wait to see them tinker with dosage for optimal regrowth. And even if Minox and Propecia are better (they aren't), you can still use that and this. This just means more hair.