Replicel Trial Update

[DepressedByHairLoss]

I'm glad that Replicel seems to be moving along with its trials and that its management is very optimistic about the possible results, but I am still disappointed with the estimated time to market being 2015 at the soonest. These things always seem to take longer than expected, so if 2015 is the ETA, then who knows when it will really be released. Of course, even if the 2015 estimate is accurate, this wouldn't necessarily mean the product would be relased on January 1, 2015 and be immediately available to anyone who wants it. If the company is not on top of this, there could be real lags with distribution and with training physicians in the new procedures.

I am also disappointed that in the interview, the CEO seemed to indicate that the product will undergo a full three-phase set of clinical trials, and there was no mention of an early release in non-Western countries following the completion of the Phase I safety or Phase II dosing trials. I think many of us were hoping for something like this, so that those of us willing to travel could benefit from the product sooner. There was also no mention of the controversy surrounding whether the U.S. FDA has the right to regulate autologous cell treatments, and the potential for a quicker time to market should the U.S. courts side against the FDA.

Me too, I'm very disappointed that the optimistic ETA appears to be 2015. And I'm also very disappointed that there was no mention of an early release in non-Western countries, and that they're going through a full 3-phase set of clinical trials. Although I certainly appreciate the efforts of these companies (years ago, nobody was doing a damn thing to try to cure baldness), it seems like there is no sense of urgency at all to their efforts to get this out as soon as possible. I mean, I understand they need to prove that this method works effectively and is safe, but in the meantime we all have to live at least 4 more years as balding men, which is just hell for me. Also, since this treatment is autologous, I really don't think that they need to do the full 3-phase clinical trial. After all, there are plenty of autologous treatments being performed today that haven't gone through such rigorous clinical trials, or even any clinical trials at all for that matter. PRP or autologous adipose stem cell therapy are perfect examples. I know that PRP doesn't work, but Replicel's method has already obviously exceeded the expectations of PRP in every way. I know that Replicel's method needs to undergo some form of clinical trials, but since their method is autologous, I really don't think that they need to be nearly as extensive as they are now. I mean, 2015 may be an optimistic timeline for some, but that still means that we've got to live shitty, balding lives for at least 4 more years, which is just a terrible option for me. I can't help but think that if some of these scientists that were developing these treatments were actually balding themselves, then maybe they would understand the misery and depression that go along with living life as a balding man, and would get something out to us sooner. I mean, if you don't actually feel for yourself that misery and depression of living life as a balding man, then you can't really know how bad it is.

[NeedHairASAP]

Hey guys, lets not get ahead of ourselves. It's still possible that it doesn't work.

Now, let's say it does. What's this nonsense about 20% regrowth? The way their videos describe the technology, and the explanations we hear from their scientists about how the mechanism works, why and how do they arrive at 20%? Logically speaking (using their logic) should this not be full density?

Now let's say it's only 20% regrowth. Is that 20% of full density, or 20% increase of the hairs on your head? Like if Jason Statham goes in to get this done with his 100 hairs on the top of his head, does he walk out with 120? If that's the case then all of us are here are effed come 2016.

i agree, it should either work or not work... doesn't make sense that it only works a little

[lockness]

Two things that I think are silly that we don't have...a hairloss cure (or substantial treatment) and an electric car that doesn't need petrol whatsoever. We *know* the tech is there, were just stuck dealing with extortionist industries.

[HairTalk]

There's no evidence, at the moment, RepliCel does anything positive with regard to hair restoration, in people. The company currently is performing its first in-human trial, and no results about efficacy have yet been shared (we've been told they will be, around March, 2012).

If the process works, great; but let's not get ahead of ourselves.

[RichardDawkins]

Will work, thats it. There approach is good.

This will stop hair loss and gain new hair or more density. In my opinion has potential for a cure.

Anyway dont be pissed because we dont have a cure, the reason for this is simple, hair loss was never been an issue from a problematic point of view.

Hey even liposuction or stomach decreasing wasnt available since ages, its only getting prominent when demand rises.

And now demand rises in terms of how and with what comapnies can make money and targeting hair loss is an easy goal for them (of course FDA sucks)

Oh and before people argue " They wont bring it to market because the profit will make this vanish because they dont want a cure"

This argument is not true because with a full head of hair they make muc more money. For example

1) combs
2) shampoos
3) conditioners
4) hair spray
5) hair gel
6) colouring hair
7) cutting hair
8) pills and vitamins to make your hair shine

etc etc

And now the question for you if you were in charge

Would you prefer to get money from the all above or would you rely on Propecia and Minox which only a fracture of baldies even use?

I would surely prefere the first option because its much more money and even with us baldies there will be plenty of idiot when they got their hair back, to pay 20 dollars for a shampoo which is said to make your hair shine

[Flowers]

Will work, thats it. There approach is good.

This will stop hair loss and gain new hair or more density. In my opinion has potential for a cure.

Anyway dont be pissed because we dont have a cure, the reason for this is simple, hair loss was never been an issue from a problematic point of view.

Hey even liposuction or stomach decreasing wasnt available since ages, its only getting prominent when demand rises.

And now demand rises in terms of how and with what comapnies can make money and targeting hair loss is an easy goal for them (of course FDA sucks)

Oh and before people argue " They wont bring it to market because the profit will make this vanish because they dont want a cure"

This argument is not true because with a full head of hair they make muc more money. For example

1) combs
2) shampoos
3) conditioners
4) hair spray
5) hair gel
6) colouring hair
7) cutting hair
8) pills and vitamins to make your hair shine

etc etc

And now the question for you if you were in charge

Would you prefer to get money from the all above or would you rely on Propecia and Minox which only a fracture of baldies even use?

I would surely prefere the first option because its much more money and even with us baldies there will be plenty of idiot when they got their hair back, to pay 20 dollars for a shampoo which is said to make your hair shine

Good point. If you have hair, you have to have at least some of that stuff you listed. If you're bald, chances are you're not doing anything about it anyway so I'd say companies who make products for people with hair make more money than companies who make products for bald people

[hollywoodkid]

Just sayin', I sense a change of tone in their pitch, and the language has switched more to a 'preventing' baldness angle vs. reversing baldness:

http://biotuesdays.com/2011/10/18/replicel%E2%80%99s-cell-based-solution-to-hair-loss/

[RichardDawkins]

1) this is from octobre so its in this case not the latest if you consider the interview

2) they talk about both, preventing or stopping hair loss is btw a byproduct of a succesfull cell solution, dont think you get your hair back which was lost and all the remain hair falls out or something

Cells or their genetic material is sucked into dormant follicles or long time dormant ones. There is also a hich chance for a chain effect, if one hair gets reawaken that others around will also get awaken too, but thats more likely of the injection pattern rather then cellular dialogue between follicles.

Also if something stops hair loss this would also mean that all current affected mini vellus hairs would also come back to trminal hair BECAUSE they are in the minituarizing process

[Jundam]

People here need to understand that 20% is not what they are predicting. 10% is what they need to rival the other treatments on the market and continue with phase II dosing trials, 20% or more is what they would want to attract attention and funding from Big Pharma/Big Biotech or independent investors depending on which business module they choose.

You need to understand that they are not running a commercial campaign. They're not trying to peddle a product. All they're doing right now is telling those interested what they are working on and what results they need to see in order to continue working on it.

It always baffles me when people try to predict the outcome of things they do not understand. If the scientists have yet to find an answer, you're probably not going to beat them to the punch by pooling knowledge from forums and Wikipedia.

[HairTalk]

10% is what they need to rival the other treatments on the market and continue with phase II dosing trials, 20% or more is what they would want to attract attention and funding from Big Pharma/Big Biotech or independent investors depending on which business module they choose.

That contradicts what David Hall has said in interviews: 20% or more will allow them to rival current (Nov., 2011) drug threapies for treatment of hairloss. I'm unsure whence you've contrived your "10%" figure.

[Jundam]

I have not gone through all of his interviews and perhaps he has said different elsewhere but in the one I read from BioTuesdays.com he cited 10% as moderately successful and 20% as very successful.

Not that it had anything at all to do with my point.

[Kiwi]

I too read they need 20% growth efficiency to match propecia.

But thats just growth. Will these solutions also halt the balding process. I've been told that Histogen will.

[RichardDawkins]

Yep it will hold the hair loss

[TxRockClimber]

Interviews & 20%

I believe that you will need to listen to the actual interviews - it was either the one on Bald Truth or NBT Equities Research where David Hall (CEO, Replicel) mentioned that they were fairly confident about the 20% result. I do not have any knowledge as to why RepliCel is confident about the above figure - perhaps it was based entirely on the pre-clinical work or some other studies.

[Jundam]

I too read they need 20% growth efficiency to match propecia.

But thats just growth. Will these solutions also halt the balding process. I've been told that Histogen will.

According to the blogpost from Biotuesdays.com it was 10% to match Rogaine and 10-15% to match Propecia but that might have been the site mentioned screwing around with the numbers. I wish people would have read my post and realized the point was that the 20% number was not a prediction but a goal for the clinical trial and that nobody should hang their heads because of it. David Hall also said he believes this could be the cure for male pattern baldness; +20% is not the holy grail they're looking for, it is simply what they would consider a great result from the first phase of their clinical trials.

By the way, for those who don't know, this is not the trial phase where you attempt to optimize efficacy. It's the trial phase where you're really just trying to provide numbers that proves your concept and its safety. Even if it's 20% by the first trial phase it could be 50% by the time it hits the market.

Now go outside, smell a rose, drink a cold beer and try to think of something else until March...