Histogen Announcement

[rdawg]

I'm okay with using HSC as a maintenance treatment with dut/rogaine. I don't care about that. I just want it to come out.

Agreed, I hope at least they expand the trials a bit or give us some info to join in, because I would love to be a participant!

It's like we have this product that works but we cant touch it for at least 2-3 years!

[Javert]

I dont understand why Histogen cant start treating people NOW in Asia? We already have two successful clinical studies surely that's enough?

All this regulation is really holding back medical research - and thanks to stupid Americans voting for OBAMA it's going to get worse - all of the new discoveries are happening in China because the people in the West have lost their ****ing balls.

I also agree that this will be a better alternative to FIN/MINOX - it wont grow hair on a slick bald scalp but it may rescue scalp hairs that are significantly minaturized - that could really make all the difference to a decent HT.

Err Obama isn't against medical research.

[rdawg]

True hey...Spoken wisely

Hey desmond, just curious if you would know

what exactly would be holding Histogen back from starting Phase IIb?? it seems they just got the funding, so why not start within a few weeks?

I mean we're just guessing but what could possibly be the hold up.

[greatjob!]

All this regulation is really holding back medical research - and thanks to stupid Americans voting for OBAMA it's going to get worse

You're drunk UK, go home.

[Kiwi]

You're drunk UK, go home.

Obama ain't as bad as Bush! That Christian nut job thought stem cell research and science was the devil.

[UK_]

Calm down people I was trolling.

[Atum]

Can't wait for this to be released.
To bad it's another 2years(?) when it get's released.....hope my hair holds out.

[burtandernie]

I guess its all relative to where you are but I would more happy to have CB 03 01 then this just based on I want to keep my hair right now verses needing to regrow or anything

[Desmond84]

Hey desmond, just curious if you would know

what exactly would be holding Histogen back from starting Phase IIb?? it seems they just got the funding, so why not start within a few weeks?

I mean we're just guessing but what could possibly be the hold up.

Starting a clinical trial is not an easy task. These are just some of the things they need to get done:

- Apply to conduct a clinical trial to the responsible government body (wherever they are planning to conduct a trial)

- Write up a draft study protocol (primary & secondary endpoints, inclusion/exclusion criteria, etc)

- Present it to the Regulatory bodies and the Ethics Committees at the hospitals they are going to conduct these trials

- Receive an approval from both the government and the ethics committee to conduct the trial

- Finalise study protocol

- Sign up investigators (doctors) who will conduct the trial and train them on how to perform the injections

- Sign up trial subjects

Just these processes take approx. 6-12 months. P.S. Phase 2b is generally larger than 2a meaning they will have to get somewhere around 300 trial subjects.

Let's hope that over the last 12 months, they have at least come up with a draft protocol to speed things up a bit.

[rdawg]

Just these processes take approx. 6-12 months. P.S. Phase 2b is generally larger than 2a meaning they will have to get somewhere around 300 trial subjects.

Let's hope that over the last 12 months, they have at least come up with a draft protocol to speed things up a bit.

Yea but SOME of those have to have been done since finishing IIa, I highly doubt they've been sitting around for the last 6-8 months, they have to be close to only having the last few things you mentioned left to do.

[Desmond84]

Yea but SOME of those have to have been done since finishing IIa, I highly doubt they've been sitting around for the last 6-8 months, they have to be close to only having the last few things you mentioned left to do.

I really hope so! If the protocol and the trial approval process is done then they will be able to start by Feb 2014...if not probably July-Aug 2014

I havent watched the presentation yet. Did they mention anything about a timeline for Phase 2b?

[HairBane]

Yea but SOME of those have to have been done since finishing IIa, I highly doubt they've been sitting around for the last 6-8 months, they have to be close to only having the last few things you mentioned left to do.

Exactly. It's kind of cute how the guys on this forum just 'hope' that silly Histogen can figure these things out. It's their livelihood, they'll get it done as soon as they can.

[HairBane]

I really hope so! If the protocol and the trial approval process is done then they will be able to start by Feb 2014...if not probably July-Aug 2014

I havent watched the presentation yet. Did they mention anything about a timeline for Phase 2b?

They didn't, they just said 'soon' I think.

Also, from Replicel's website:

"RepliCel's RCH-01 Phase II dose-ranging trial of approximately 120 subjects is targeted for the first half of 2014 and will run through 2015. The trial will be conducted in Germany."

That's phase 2b right? So Histogen and Replicel are neck-and-neck?

[rdawg]

They didn't, they just said 'soon' I think.

Also, from Replicel's website:

"RepliCel's RCH-01 Phase II dose-ranging trial of approximately 120 subjects is targeted for the first half of 2014 and will run through 2015. The trial will be conducted in Germany."

That's phase 2b right? So Histogen and Replicel are neck-and-neck?

IIa I believe, Histogen is one phase ahead.

Aderans was the farthest along, but failed to produce results.

Bim however is going to IIb I believe as well soon

[HairBane]

IIa I believe, Histogen is one phase ahead.

Aderans was the farthest along, but failed to produce results.

Bim however is going to IIb I believe as well soon

Are you sure? http://youtu.be/9SjQAfiKAk0?t=3m46s