Histogen and Replicel : stem cell meeting on the Mesa

[brocktherock]

I want to know something. If histogen has had no toxicity whatsoever can you raise the dosage as high as you want? I understand phase 2 is the efficacy and dosage trial but they haven't stated when the treatment stops growing new hair.

[FearTheLoss]

How do you know that? Was there any annoucements?

The fact that there wasn't any announcements. We know that funding has been holding them back for over a year now and we know they've been seaking investors. They planned to start in the beginning of 2015 but still haven't announced that or a partner.

[rambo007]

How do you know that? Was there any annoucements?

[FearTheLoss]

Histogen still hasn't found a partner or got funds to announce starting of the phase 2b trial in the beginning of 2015. It looks like more delays or and end for histogen as its been quite some tjme now, unfortunately.

[Scientalk56]

Phase 2b

- Pre-clinical Phase: also known as "Proof of concept trials" and is conducted in Animals, Skin grafts, etc

- Phase 1: First in man trial. Aim is safety and pharmacokinetic data (~10-20 trial subjects)

- Phase 2: Examines safety & efficacy and is usually divided in TWO parts:

Phase 2a: is generally known as the "Dose-range finding study" and is conducted in about 50 patients. It examines dose-response relationships, frequency of dosing, and safety & efficacy of different doses, etc. This is how far Histogen has gotten btw.

Phase 2b: is known as the "pivotal trial", which is a rigorous study conducted in about 200-300 patients and examines the efficacy of specific doses & frequencies chosen from Phase 2a trial. It is generally longer than Phase 2a trials as well.

- Phase 3: is a large, blinded clinical trial conducted in around 2000-3000 patients and generates additional data on safety & efficacy. It generally lasts the same amount of time as Phase 2b trial (in this case 12-18 months).

quote from: http://www.alopeci.info/index.php?th...et-p%C3%A5.32/

[noisette]

Article newspaper on replicel, aderans and stemcell

An interesting article newspaper, not recent new but interesting

http://www.vancouversun.com/health/Stem+cell+technology+used+search+holy+grail+hair+treatments+cure+baldness/9085427/story.html

[paulneedshair]

i like the look of this trial. cant wait

[macbeth81]

Replicel's study:

https://clinicaltrials.gov/ct2/show/...opecia&rank=14

Isn't that their Phase I/IIa trial not their Phase IIb trial? The initial safety trial is still ongoing.

[paulneedshair]

i think replicel or histogen will cure us, at least get us close to a cure.

[hellouser]

Replicel's study:

https://clinicaltrials.gov/ct2/show/...opecia&rank=14

That's for US trials, correct?

Is there a listing like that for the Japanese release?

[rambo007]

Replicel's study:

https://clinicaltrials.gov/ct2/show/study/NCT01286649?term=androgenic+alopecia&rank=14

[Pate]

Nice presentation from Replicel, glad to see they are pushing ahead. If this stuff works, this trial should give us a pretty good idea. And a second trial in Japan too, free of cost to Replicel.

Pity we have to wait til 2016 for the results, but we all know how slow this game is by now...

[JimmyHairte]

Not a chance, you can bet both your testicles that the signups for the trials are complete as they're moving along with Phase II within a few months. Sorry dude.

Yeah, that's pretty much what I was expecting. I just saw their sign-up form and thought to give it a try:

http://www.replicel.com/contact-us/clinical-trials-sign-up/

Might be they just haven't updated their site in a while.

[hellouser]

I applied for the Replicel trials in Germany earlier today. Not sure what the chances are. Let's hope for the best, although I'm not too optimistic.

I will keep you posted though.

Not a chance, you can bet both your testicles that the signups for the trials are complete as they're moving along with Phase II within a few months. Sorry dude.

[JimmyHairte]

I applied for the Replicel trials in Germany earlier today. Not sure what the chances are. Let's hope for the best, although I'm not too optimistic.

I will keep you posted though.