Histogen's FINAL Phase I/IIa Results (2013)

[Desmond84]

Most of this was pretty obvious before they released the last presentation.

I guess you're right it is kind of a let down if you expected HSC to cure baldness on its own. But to those who had more realistic expectations this is just exactly what we thought it would be and it will be of great help in the future.

It will be more than helpful for sure! It will definitely be added to our Gold Standard regimen! I personally think it may make Minoxidil redundant for those that obviously can afford it!

Me and my wife where about ready to protest the show. SMH I honestly felt sick after it ended. My favorite family is pretty much wiped out now. Long Live the North!

The North will never forget!

[ResearchNeverfails]

OK, I just finished watching Game of Thrones! What on earth!!!!

This week just keeps getting worse!

Me and my wife where about ready to protest the show. SMH I honestly felt sick after it ended. My favorite family is pretty much wiped out now. Long Live the North!

[Thinning87]

Guys, when I wrote the initial post, my aim was NOT to write off Histogen. I was simply highlighting the points that were NOT known up until the recent announcement.

I think it's important to clear up what these results showed:

1) Histogen was ABLE to INCREASE Terminal hair count by up to 40%! That is VERY GOOD by all of today's standards.

2) The vellus hair count dropped significantly after 24 weeks, because obviously they had turned terminal.

3) The total hair count however, did NOT change all that much in the temporal area (temples). Total hair count in other areas of treatment were NOT provided and hence anything we say about it will be speculation.

__________________________________________________ ____________
What these 3 points highlight is that Histogen RESCUES DYING FOLLICLES by turning vellus hairs into terminal. It puts these hairs into a long-term ANAGEN phase...hence, its overall mechanism of action is very similar to Minoxidil!

However, Histogen has a much longer biological half-life as patients remained above baseline for 48 weeks after 2 applications...whereas, the effects of Minoxidil last 12 hours, thereby requiring TWICE DAILY application!

So in comparison to Minoxidil, it provided far greater potency in terms of increasing the terminal hair count.
__________________________________________________ _____________

4) Follicular neogenesis (brand new follicles) did NOT occur! Or if it did, it was not statistically significant (i.e. 2.5%)...Hence, it is fair to say it will thicken up recently thinning areas BUT will NOT do much on slick bald areas.

This was clearly evident in the Ziering photos that was published in October 2012...It had simply thickened up the thinning areas in the male patients

5) The potential for toxicity is there...BUT
The BUT makes all the difference.... Histogen still does NOT know the safe dose range! So far, they have injected up to 40 injections per session without any signs of toxicity (Zieiring trial). 40 shots would approximately cover a 2.5 cm2 area!

Their Phase IIb trial which is the "Dose-range finding" trial will clarify this critical question! If we can get 100 injections per session without the risk of toxicity then we will be able to maintain our hairline for a very long time to come!

CB-03-01 will become available at around the same time to take care of the crown...

__________________________________________________ ______________

Finally, I'd like to say that losing your hair is very traumatic for most. We are all emotional and we all would like this to end! So we are hoping for a silver bullet that will fix everything! Unfortunately, as we all have figured out, there is no such thing...In the future, we will most probably need a combination of treatments to combat AGA!

What's important is these tools are becoming available...But non of them are perfect and they all will have pros and cons...

Our aim should be to study these therapies thoroughly and get a full picture of what to expect from these treatments rather than what we would like it to do...

My aim was to help those with no medical background to fully understand what was being presented by Histogen without bias! No one likes to be the carrier of bad news and many are upset with me for highlighting the possible limitations of Histogen! BUT like I promised, I will NOT be putting any of you guys at risk of a possible harm by being overly optimistic and blinded by false hope! I will never forgive myself if I missed a critical piece of information and put some of you guys in the harms way!

Hope that makes ppl a bit more happy!


Regards,

- Semi-optimistic Des

Most of this was pretty obvious before they released the last presentation.

I guess you're right it is kind of a let down if you expected HSC to cure baldness on its own. But to those who had more realistic expectations this is just exactly what we thought it would be and it will be of great help in the future.

[garethbale]

Dude I can't believe how sad you have been in these past few days. There's been nothing but great news lately!!

I wouldn't say its great but it's not disastrous as some people are making out

[Thinning87]

LOL, as much as I love Iron_Man, he can be condescending sometimes and can upset ppl...I really hope he changes for the better !

Everyone's contribution counts though...as long as we are civilised He has this uncanny ability to read between the lines which can be useful lot of the times. He highlighted a lot of points on the last Aderans presentation which I personally missed and was grateful when he pointed them out!

He has been very quiet about Histogen to my surprise! LOL

__________________________________________________ ________________

You're right about the "site-specific" difference in response though Gareth! I think that is definitely the case... the problem is if we have a limited number of injections, what area will you treat?

Dude I can't believe how sad you have been in these past few days. There's been nothing but great news lately!!

[garethbale]

You're right about the "site-specific" difference in response though Gareth! I think that is definitely the case... the problem is if we have a limited number of injections, what area will you treat?

If not sure if that was a rhetorical question but my answer would be the hairline and temples, as that's the only area I have lost hair. Which is annoying is also the hardest area to regrow hair

[Desmond84]

LOL, as much as I love Iron_Man, he can be condescending sometimes and can upset ppl...I really hope he changes for the better !

Everyone's contribution counts though...as long as we are civilised He has this uncanny ability to read between the lines which can be useful lot of the times. He highlighted a lot of points on the last Aderans presentation which I personally missed and was grateful when he pointed them out!

He has been very quiet about Histogen to my surprise! LOL

__________________________________________________ ________________

You're right about the "site-specific" difference in response though Gareth! I think that is definitely the case... the problem is if we have a limited number of injections, what area will you treat?

[garethbale]

You are right! If you increase terminal hair count by 25% and reduce vellus hair count by 5% then where did 20% of those terminal hairs come from? And if they are new hairs then why doesn't the number of Total hair count reflect that?

I really don't know the answer to that unfortunately! Iron_man is a great trichologist though and might enlighten us!

Another important point that I didn't mention was that Total Hair count increased by 10% in other areas. Only the temples ended up with a 2.5% increase in hair count!

Your point about temple hair was something I had picked up on earlier Desmond, I think. If terminal hair haid increased on other areas of the scalp but only marginally on the hairline/temples, that's not that bad. The temples seem very hard to regrow hair anyway.

As for your suggestion about asking for IM's advice, please don't entertain him!!!

We'll just get a comment with loads of unnecessary inverted commas, words in capitals, 'rolling eyes' smileys and to finish it off, the standard 'pffffttt'

[Desmond84]

Actually when you think about, these are percentages NOT hair count numbers...so, if the numbers of vellus hairs does not equal terminal hairs, then comparing the change in % of vellus hairs to change in % terminal hairs is irrelevant!

Total hair count is relevant to those guys that are trying to grow hair on areas that are pretty bare!

[Desmond84]

Desmond, how about you be the president of baldies
We should have elections lol!

just a question regarding temples:



Total hair count means both vellus and terminal hair count, and all we need is cosmetically significant hair on temples (terminal).. so why we are looking at total hair count?

I think we really need to see pictures of temples of the patients (and also the rest of the scalp) to decide whether the growth is good or not..
whether the numbers are good or bad - we still need to see some pics!


Let's hop for the best

You are right! If you increase terminal hair count by 25% and reduce vellus hair count by 5% then where did 20% of those terminal hairs come from? And if they are new hairs then why doesn't the number of Total hair count reflect that?

I really don't know the answer to that unfortunately! Iron_man is a great trichologist though and might enlighten us!

Another important point that I didn't mention was that Total Hair count increased by 10% in other areas. Only the temples ended up with a 2.5% increase in hair count!

[Scientalk56]

Desmond, how about you be the president of baldies
We should have elections lol!

just a question regarding temples:

HSC treatment showed hair growth in the temporal recession region at 12 weeks and continuing through 48 weeks, with strong efficacy in terminal hair count.

Total hair count means both vellus and terminal hair count, and all we need is cosmetically significant hair on temples (terminal).. so why we are looking at total hair count?

I think we really need to see pictures of temples of the patients (and also the rest of the scalp) to decide whether the growth is good or not..
whether the numbers are good or bad - we still need to see some pics!


Let's hop for the best

[Desmond84]

Am I missing something? Histogen didn't report no growth. If there are no toxicity issues you can HSC your whole head to maintain what you got.

And see Gho for some density if you need it.

Desmond is there anything I'm saying that isn't true?

Guys, when I wrote the initial post, my aim was NOT to write off Histogen. I was simply highlighting the points that were NOT known up until the recent announcement.

I think it's important to clear up what these results showed:

1) Histogen was ABLE to INCREASE Terminal hair count by up to 40%! That is VERY GOOD by all of today's standards.

2) The vellus hair count dropped significantly after 24 weeks, because obviously they had turned terminal.

3) The total hair count however, did NOT change all that much in the temporal area (temples). Total hair count in other areas of treatment were NOT provided and hence anything we say about it will be speculation.

__________________________________________________ ____________
What these 3 points highlight is that Histogen RESCUES DYING FOLLICLES by turning vellus hairs into terminal. It puts these hairs into a long-term ANAGEN phase...hence, its overall mechanism of action is very similar to Minoxidil!

However, Histogen has a much longer biological half-life as patients remained above baseline for 48 weeks after 2 applications...whereas, the effects of Minoxidil last 12 hours, thereby requiring TWICE DAILY application!

So in comparison to Minoxidil, it provided far greater potency in terms of increasing the terminal hair count.
__________________________________________________ _____________

4) Follicular neogenesis (brand new follicles) did NOT occur! Or if it did, it was not statistically significant (i.e. 2.5%)...Hence, it is fair to say it will thicken up recently thinning areas BUT will NOT do much on slick bald areas.

This was clearly evident in the Ziering photos that was published in October 2012...It had simply thickened up the thinning areas in the male patients

5) The potential for toxicity is there...BUT
The BUT makes all the difference.... Histogen still does NOT know the safe dose range! So far, they have injected up to 40 injections per session without any signs of toxicity (Zieiring trial). 40 shots would approximately cover a 2.5 cm2 area!

Their Phase IIb trial which is the "Dose-range finding" trial will clarify this critical question! If we can get 100 injections per session without the risk of toxicity then we will be able to maintain our hairline for a very long time to come!

CB-03-01 will become available at around the same time to take care of the crown...

__________________________________________________ ______________

Finally, I'd like to say that losing your hair is very traumatic for most. We are all emotional and we all would like this to end! So we are hoping for a silver bullet that will fix everything! Unfortunately, as we all have figured out, there is no such thing...In the future, we will most probably need a combination of treatments to combat AGA!

What's important is these tools are becoming available...But non of them are perfect and they all will have pros and cons...

Our aim should be to study these therapies thoroughly and get a full picture of what to expect from these treatments rather than what we would like it to do...

My aim was to help those with no medical background to fully understand what was being presented by Histogen without bias! No one likes to be the carrier of bad news and many are upset with me for highlighting the possible limitations of Histogen! BUT like I promised, I will NOT be putting any of you guys at risk of a possible harm by being overly optimistic and blinded by false hope! I will never forgive myself if I missed a critical piece of information and put some of you guys in the harms way!

Hope that makes ppl a bit more happy!


Regards,

- Semi-optimistic Des

[Scientalk56]

By the time Histogen come to market, I wont have anything left to hold on to - unless I bite the bullet and take finasteride, which I still cant bring myself to do.

Exactly the same...
I hope Phase IIb trial will prove efficacy on totally bald scalps...(sounds a little impossible - but we have no choice but histogen)

[UK_]

Am I missing something? Histogen didn't report no growth. If there are no toxicity issues you can HSC your whole head to maintain what you got.

And see Gho for some density if you need it.

Desmond is there anything I'm saying that isn't true?

By the time Histogen come to market, I wont have anything left to hold on to - unless I bite the bullet and take finasteride, which I still cant bring myself to do.

[Kiwi]

There comes a time in every bald truthers life that he has to accept the obvious.

Its over guys. We're done.

Am I missing something? Histogen didn't report no growth. If there are no toxicity issues you can HSC your whole head to maintain what you got.

And see Gho for some density if you need it.

Desmond is there anything I'm saying that isn't true?