Also, can companies release a product after phase 2? I've heard of that happening but what is the protocol on that?
It depends on which regulatory agency you're talking about. In the case of the FDA, it is possible for them to approve a drug for marketing while Phase III trials are still underway, but I don't know that they would give much priority to a treatment that addresses a cosmetic issue rather than a life-threatening medical condition.
Cool, thanks for bringing this up, the trial no longer says 'recruiting' like it did in Dec so it appears they have officially started phase I/II finally! Says that they plan to have primary results by June and the trial will be finished by the end of the year. Nice to see a relatively short phase I/II trial, I know they may then do another or something before phase III but it's still encouraging. Really hope we hear good stuff over the next 6 months from Histogen & Replicel. Hope Aderans continues to progress too but I don't think we'll hear much til they finish phase II next year although I'm still keen to hear Spencer's upcoming interview with Ken.
02-01-2012 09:33 AM
KeepHoping
A lady from Histogen sent me an email a few weeks ago saying they had started and all the participants had been injected and they look forward to sharing news soon, so I think it shouldn't be too long before a 12 week update, if they decide to have a 12 week update like they did in the safety pre-trial.
02-01-2012 02:33 PM
UK_
Quote:
Originally Posted by KeepHoping
A lady from Histogen sent me an email a few weeks ago saying they had started and all the participants had been injected and they look forward to sharing news soon, so I think it shouldn't be too long before a 12 week update, if they decide to have a 12 week update like they did in the safety pre-trial.
Does it give a specific date as to when they started? Through this email can you yoruself confirm whether it was really a July start?
Could you possibly PM or post the entire email up?
Thanks.
02-01-2012 09:22 PM
KeepHoping
I asked if they had started the trail and this was the response:
"In response to your further questions, all 55 subjects have been enrolled and injected in the Phase I/II clinical trial of HSC, and that trial is currently in progress.
Best,
Eileen"
And in an earlier email she said:
"Thank you for your interest and message. Please excuse the delay in my response, we are working through a large number of inquiries. In response to your question, the mechanism of action of HSC indicates that the complex both stimulates existing follicles to produce new hairs as well as triggers stem cells in the scalp to become new hair follicles. Details from the pilot trial of HSC can be found on our website, and we look forward to sharing data from the Phase I/II trial in the coming months."
02-02-2012 12:01 AM
sausage
Quote:
Originally Posted by KeepHoping
I asked if they had started the trail and this was the response:
"In response to your further questions, all 55 subjects have been enrolled and injected in the Phase I/II clinical trial of HSC, and that trial is currently in progress.
Best,
Eileen"
And in an earlier email she said:
"Thank you for your interest and message. Please excuse the delay in my response, we are working through a large number of inquiries. In response to your question, the mechanism of action of HSC indicates that the complex both stimulates existing follicles to produce new hairs as well as triggers stem cells in the scalp to become new hair follicles. Details from the pilot trial of HSC can be found on our website, and we look forward to sharing data from the Phase I/II trial in the coming months."
How long do they wait to see growth? I bet they must wait a year and study every guinea pigs heads after that time even if say 80% of them grow hair in the first month they probably wait to see if it lasts and also wait to see if growth eventually happens in the other 20%.
So I guess the trials take a year at a time?
02-02-2012 03:12 AM
Pate
Quote:
Originally Posted by sausage
How long do they wait to see growth? I bet they must wait a year and study every guinea pigs heads after that time even if say 80% of them grow hair in the first month they probably wait to see if it lasts and also wait to see if growth eventually happens in the other 20%.
So I guess the trials take a year at a time?
Last time they released initial results at 3 months, then 5 months, then 12 months.
The growth was fair at 3 months, then slipped a bit at 5 months, and it was looking like HSC wasn't long term.
But then at 12 months the results were even better than at 3 months. So it looks like the 5 months was just the new growth cycling before coming back stronger.
If you really want to know all about the last trial, click on the link to their scientific paper published in the dermatology journal and buy a copy of it. Or alternatively find somebody with online journal access (a university student or researcher) and get them to get a copy of it for free.
02-02-2012 10:03 AM
UK_
Quote:
Originally Posted by Pate
But then at 12 months the results were even better than at 3 months. So it looks like the 5 months was just the new growth cycling before coming back stronger.
If you really want to know all about the last trial, click on the link to their scientific paper published in the dermatology journal and buy a copy of it. Or alternatively find somebody with online journal access (a university student or researcher) and get them to get a copy of it for free.
Yeah that 12 month peak was really promising, it showed that the HSC had a lasting impact on the actual growth cycle, im glad to hear of them communicating with the public, its nice of them and we should all appreciate that. It is also great to hear that they've been cracking on with Phase I/II.
Thanks for posting up the email KeepHoping.
02-02-2012 01:09 PM
sausage
Does anyone know if those people still have the new hair that grew during those tests?
