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needhairasap

01.06.2013, 10:24
 

HISTOGEN FAILS (Hair Multiplication & Stem Cells Treatment)

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.




needhairasap is located in [NA] and he is available to meet: NO


Post reply
jarjarbinx

01.06.2013, 10:47
(edited by jarjarbinx, 01.06.2013, 11:11)

@ needhairasap

HISTOGEN FAILS

... as though I should have realized that that the treatment results would turn out as they did. A lot of people have been expecting Histogen's results to turn out better than they have.
And of course you act so superior as if 6 months ago you foresaw the results as they ended up. What a laugh. You're a blowhard.

That having been said. I'm surprised and by Histogen's results. I never would have imagined or expected this result. I thought for sure that Histogen would prove to be a blockbuster treatment. I don't get it. This result is totally different from their previous study result. This study result is a huge departure from their first study result.

And what about the initial early data release for this same study which showed obvious regrowth in the patients and there was a picture of a lady's result which showed what looked like total reversal of hair loss.

It looks to me like the treatment was wearing off by the 36th week so patients would need booster shots more than once per year. It looks to me like the patients would need booster shots once every 6 months or thereabouts. I don't think that having booster shots every 6 months is a big problem but I am concerned about safety issues now. The safety profile has changed more dramatically even than the efficacy profile IMO.





Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.





jarjarbinx is located in [NA] and he is available to meet: NO


Post reply
AleMB81

01.06.2013, 11:10

@ jarjarbinx

HISTOGEN FAILS

This is not a good news for anyone :\ one weapon gone :\




AleMB81 is located in [NA] and he is available to meet: NO


Post reply
hairman2

01.06.2013, 11:30

@ jarjarbinx

HISTOGEN FAILS

<edited by HairSite - rude comment>

You have been proclaiming that the cure is here for months now, with absolutely nothing to back it up... even discouraging new research approaches because we already have a cure :D

you were equally enthusiastic about PGD2 blockers in the beginning, attacking everyone who dared to think differently. Now you did the same with histogen.. i wonder what will be next.

also, in your <edited> simple world... more is always better.. which is why you kept repeating <edited> that repeat injections and higher doses will bring the cure.

You stubbornly refused to even consider the fact that there may be good reason why histogen is NOT applying injections every few weeks. roger_that (and I) pointed out this issue of toxicity numerous times as you know.

You refused to acknowledge that the figures provided by histogen were in strong contrast to what histogen showed us in patient pictures. There was very little improvement in the general appearance. This should have made you wonder, as it did for the rest of us.

Even the fact that histogen admitted to having trouble finding funding for their product didnt ring alarm bells for you. Naturally if there results were spectacular then they would not have any trouble getting funding.

But then again, i forget that you are "almost always right" in arguments :rotfl: I really wonder when you are going to wake up and realize how deluded you are.


You call me a "retard" as though I should have realized that that the treatment results would turn out as they did. A lot of people have been expecting Histogen's results to turn out better than they have.
And of course you act so superior as if 6 months ago you foresaw the results as they ended up. What a laugh. You're a blowhard.

That having been said. I'm surprised and by Histogen's results. I never would have imagined or expected this result. I thought for sure that Histogen would prove to be a blockbuster treatment. I don't get it. This result is totally different from their previous study result. This study result is a huge departure from their first study result.

And what about the initial early data release for this same study which showed obvious regrowth in the patients and there was a picture of a lady's result which showed what looked like total reversal of hair loss.

It looks to me like the treatment was wearing off by the 36th week so patients would need booster shots more than once per year. It looks to me like the patients would need booster shots once every 6 months or thereabouts. I don't think that having booster shots every 6 months is a big problem but I am concerned about safety issues now. The safety profile has changed more dramatically even than the efficacy profile IMO.





Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.

Originally Posted by jarjarbinx





hairman2 is located in [NA] and he is available to meet: NO


Post reply
hairman2

01.06.2013, 11:32

@ AleMB81

HISTOGEN FAILS

agreed. the results are very unfortunate, but in this industry we should slowly be used to disappointments.

Originally Posted by AleMB81

This is not a good news for anyone :\ one weapon gone :\





hairman2 is located in [NA] and he is available to meet: NO


Post reply
jarjarbinx

01.06.2013, 11:52
(edited by jarjarbinx, 01.06.2013, 12:20)

@ hairman2

HISTOGEN FAILS

* Your opinion is sh!t, but I do bestow upon you the right to have a sh!t opinion. Are we cool now? You can have all of the sh!t opinions that you want to have.

* I based my opinion on the results of the 1st study and the preliminary 1/11 study results. There was nothing unreasonable about that. Lots of other people agreed that Histogen looked very promising.

* Now that I have the new final 1/11 results I'm adjusting my posit accordingly. I think that Histogen's news is disappointing but I don't think the results means the treatment isn't viable. I think it could still be viable and it could still be a significant improvement over existing treatments.

1. It shows that the benefit of the treatment started to wear off after 36 weeks so booster shots would need to be done every 6 months. I don't see any problem with booster shots every 6 months.

2. We need more info about the hemoglobin count issue. We need to know how much the hemoglobin count changed, and how long it took after injection for the hemoglobin count to revert back to baseline. For all we know the change in hemoglobin count was minor and the hemoglobin count reverted back to baseline in a week or maybe even a day or two. If that is the case then we could have a decent amount of injections each session and sessions would only have to be 1 or 2 weeks apart. We need the specifics.

* I will notify Hairsite that your post needs to be edited for the childish name-calling in your post which will result in Hairsite having to censor some of your text.

* Neither you nor Roger_that said anything about hemoglobin count changes so you are taking credit for something you do not deserve. You and Roger-that expressed concerns about a potential cancer risk which still has not materialized so you and Roger-that are as wrong as I was.

*I'm done responding and will report your childish name-calling to Histogen so that your post can be edited as it should be.



he called you a "retard" for good reason in my opinion... mostly because you are one.

You have been proclaiming that the cure is here for months now, with absolutely nothing to back it up... even discouraging new research approaches because we already have a cure :D

you were equally enthusiastic about PGD2 blockers in the beginning, attacking everyone who dared to think differently. Now you did the same with histogen.. i wonder what will be next.

also, in your pathetically simple world... more is always better.. which is why you kept repeating like a rabies infested mongrel that repeat injections and higher doses will bring the cure.

You stubbornly refused to even consider the fact that there may be good reason why histogen is NOT applying injections every few weeks. roger_that (and I) pointed out this issue of toxicity numerous times as you know.

You refused to acknowledge that the figures provided by histogen were in strong contrast to what histogen showed us in patient pictures. There was very little improvement in the general appearance. This should have made you wonder, as it did for the rest of us.

Even the fact that histogen admitted to having trouble finding funding for their product didnt ring alarm bells for you. Naturally if there results were spectacular then they would not have any trouble getting funding.

But then again, i forget that you are "almost always right" in arguments :rotfl: I really wonder when you are going to wake up and realize how deluded you are.


You call me a "retard" as though I should have realized that that the treatment results would turn out as they did. A lot of people have been expecting Histogen's results to turn out better than they have.
And of course you act so superior as if 6 months ago you foresaw the results as they ended up. What a laugh. You're a blowhard.

That having been said. I'm surprised and by Histogen's results. I never would have imagined or expected this result. I thought for sure that Histogen would prove to be a blockbuster treatment. I don't get it. This result is totally different from their previous study result. This study result is a huge departure from their first study result.

And what about the initial early data release for this same study which showed obvious regrowth in the patients and there was a picture of a lady's result which showed what looked like total reversal of hair loss.

It looks to me like the treatment was wearing off by the 36th week so patients would need booster shots more than once per year. It looks to me like the patients would need booster shots once every 6 months or thereabouts. I don't think that having booster shots every 6 months is a big problem but I am concerned about safety issues now. The safety profile has changed more dramatically even than the efficacy profile IMO.





Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.

Originally Posted by jarjarbinx


Originally Posted by hairman2





jarjarbinx is located in [NA] and he is available to meet: NO


Post reply
AleMB81

01.06.2013, 11:58

@ hairman2

HISTOGEN FAILS

YEs hairman however it's scaring how these new products turn out not to work.. PGD2/Histogen and so on....I can't understand why finding something better it's so hard.. I'm not asking for a cure but for something better.. We are still using 20 years old products and this is incredible




AleMB81 is located in [NA] and he is available to meet: NO


Post reply
FollicleSherlock

01.06.2013, 12:02

@ AleMB81

HISTOGEN FAILS

Hey over on stopaga.com Desmond84 just posted thread on Histogen thats active and debate is on to invite them in for presentation...anyway, if want to do the same here,,,it's an idea..

As they just released this they are in marketing mode.....have them send a technical person or identify who the tech is there and we contact him/her.

I had called them last year to go over the research and they are easily accessible by phone I found....There is some guy I heard on hairsite who literally talks to them every day.. perhaps he knows name of technical person that is one to reach..thats most useful

but anyway.. here is contact info..

Address:
10655 Sorrento Valley Road
San Diego, CA 92121
Phone:
858-200-9520

For more information or to arrange a technology presentation, please contact us at bd@histogeninc.com or 858.526.3108.

(guess we say we want an online technology presentation q&a)




FollicleSherlock is located in [NA] and he is available to meet: NO


Post reply
Faker

01.06.2013, 12:43

@ FollicleSherlock

HISTOGEN FAILS

I guess I'm here to add my 2 cents in... I think the best shot we have at a cure is successfully multiplying and growing hair follicles. You just cant argue with physically putting more hair follicles on the head. Although medical advancements have been great people still don't realize how medically we are so far behind. I mean there is simple things we cant cure. Unless it's a total fluke I cant see having any medical therapy that will regrow all of our hair. I feel like we are at least 2-5 decades away from that kind of cure. When we can do this we will practically be able to cure anything we want.

Let me give a crazy analogy. Imagine a field of dead grass. Grass that has died years ago covered with dirt and so on. Imagine trying to scientifically get that grass to live again. Imagine trying to place the components necessary to bring life and reactivate that blade of grass. No I'm not talking about seeds, I'm talking about reactivating a dead blade of grass.

Now Imagine taking a healthy vibrant green living blade of grass and trying to manipulate it to grow more blades of grass while sustaining itself. I'm no expert but If I had the task of making one of these successful I would much rather prefer the latter.




Faker is located in [NA] and he is available to meet: NO


Post reply
jarjarbinx

01.06.2013, 13:04

@ AleMB81

HISTOGEN FAILS

Wait a second. We're jumping the gun here. The more I think about this the more I'm thinking that we need more information before we form a conclusion as to whether or not this is good or bad news.

There were hemoglobin count changes but how long does it take for the hemoglobin count to revert back to baseline, and how big were the hemoglobin count changes? If the changes were minor to mild, and if the changes went back to baseline in days or a week or a month, then this is not a major problem. If the hemoglobin count change was small to mild and if the change reverted back to baseline with a month then this is a minor problem




Originally Posted by AleMB81

This is not a good news for anyone :\ one weapon gone :\





jarjarbinx is located in [NA] and he is available to meet: NO


Post reply
jarjarbinx

01.06.2013, 13:11

@ AleMB81

HISTOGEN FAILS

What exactly is so bad about the study results? Is it the hemoglobin count change that for all we know is a small change and may revert back to normal rapidly for all we know? If that is the bad thing about these study results then shouldn't we first find out how big the hemoglobin count change is, how long it takes to revert back to baseline, and the % of people affected by it before we pronounce judgement?


Originally Posted by AleMB81

YEs hairman however it's scaring how these new products turn out not to work.. PGD2/Histogen and so on....I can't understand why finding something better it's so hard.. I'm not asking for a cure but for something better.. We are still using 20 years old products and this is incredible





jarjarbinx is located in [NA] and he is available to meet: NO


Post reply
jarjarbinx

01.06.2013, 13:26

@ hairman2

HISTOGEN FAILS (JARJAR A RETARD)

And for the record when I say that you and Roger_that are being proved to be as wrong as I am, I'm only talking about my previous incorrect position that we should only need booster shots every few years once we got our hair back via Histogen. Since efficacy diminishes significantly by 36 weeks it's clear that we would need booster shots about every 6 months. So far, that is the only thing I've been proved wrong about.

The issue of the hemoglobin count change could turn out to be a minor obstacle or a large obstacle. We do not know yet. But I will say is that it does appear that the hemoglobin count issue is a minor issue because Histogen was not even aware of it until the final results were completed. This means that they did not see a meaningful change when they did the preliminary data results and patients were not reporting anemia health consequences when the patients were reporting to the study clinicians.




jarjarbinx is located in [NA] and he is available to meet: NO


Post reply
hairman2

01.06.2013, 14:56
(edited by hairman2, 01.06.2013, 15:24)

@ jarjarbinx

HISTOGEN FAILS

alas, again you are twisting the truth <edited>.

http://www.hairsite.com/hair-loss/forum_entry-id-118786.html
http://www.hairsite.com/hair-loss/forum_entry-id-115363.html
http://www.hairsite.com/hair-loss/forum_entry-id-115327.html

to quote roger:
- concerns about long-term toxicity or cancer induction.
- Obviously they are spacing the injections out VERY widely for a reason. My guess is that although not all of the ingredients are toxic and/or are linked to cancer


roger and I both spoke generally of the risk of toxicity ultimately potentially even INCLUDING risk of cancer but not LIMITED to cancer.

I can dig up more of my old posts later on that if you wish.

Normally I would say I'd be wasting my time by doing so but I think it is important to expose you for the sh*ttalker that you are.

* Your opinion is sh!t, but I do bestow upon you the right to have a sh!t opinion. Are we cool now? You can have all of the sh!t opinions that you want to have.

* I based my opinion on the results of the 1st study and the preliminary 1/11 study results. There was nothing unreasonable about that. Lots of other people agreed that Histogen looked very promising.

* Now that I have the new final 1/11 results I'm adjusting my posit accordingly. I think that Histogen's news is disappointing but I don't think the results means the treatment isn't viable. I think it could still be viable and it could still be a significant improvement over existing treatments.

1. It shows that the benefit of the treatment started to wear off after 36 weeks so booster shots would need to be done every 6 months. I don't see any problem with booster shots every 6 months.

2. We need more info about the hemoglobin count issue. We need to know how much the hemoglobin count changed, and how long it took after injection for the hemoglobin count to revert back to baseline. For all we know the change in hemoglobin count was minor and the hemoglobin count reverted back to baseline in a week or maybe even a day or two. If that is the case then we could have a decent amount of injections each session and sessions would only have to be 1 or 2 weeks apart. We need the specifics.

* I will notify Hairsite that your post needs to be edited for the childish name-calling in your post which will result in Hairsite having to censor some of your text.

* Neither you nor Roger_that said anything about hemoglobin count changes so you are taking credit for something you do not deserve. You and Roger-that expressed concerns about a potential cancer risk which still has not materialized so you and Roger-that are as wrong as I was.

*I'm done responding and will report your childish name-calling to Histogen so that your post can be edited as it should be.



he called you a "retard" for good reason in my opinion... mostly because you are one.

You have been proclaiming that the cure is here for months now, with absolutely nothing to back it up... even discouraging new research approaches because we already have a cure :D

you were equally enthusiastic about PGD2 blockers in the beginning, attacking everyone who dared to think differently. Now you did the same with histogen.. i wonder what will be next.

also, in your pathetically simple world... more is always better.. which is why you kept repeating like a rabies infested mongrel that repeat injections and higher doses will bring the cure.

You stubbornly refused to even consider the fact that there may be good reason why histogen is NOT applying injections every few weeks. roger_that (and I) pointed out this issue of toxicity numerous times as you know.

You refused to acknowledge that the figures provided by histogen were in strong contrast to what histogen showed us in patient pictures. There was very little improvement in the general appearance. This should have made you wonder, as it did for the rest of us.

Even the fact that histogen admitted to having trouble finding funding for their product didnt ring alarm bells for you. Naturally if there results were spectacular then they would not have any trouble getting funding.

But then again, i forget that you are "almost always right" in arguments :rotfl: I really wonder when you are going to wake up and realize how deluded you are.


You call me a "retard" as though I should have realized that that the treatment results would turn out as they did. A lot of people have been expecting Histogen's results to turn out better than they have.
And of course you act so superior as if 6 months ago you foresaw the results as they ended up. What a laugh. You're a blowhard.

That having been said. I'm surprised and by Histogen's results. I never would have imagined or expected this result. I thought for sure that Histogen would prove to be a blockbuster treatment. I don't get it. This result is totally different from their previous study result. This study result is a huge departure from their first study result.

And what about the initial early data release for this same study which showed obvious regrowth in the patients and there was a picture of a lady's result which showed what looked like total reversal of hair loss.

It looks to me like the treatment was wearing off by the 36th week so patients would need booster shots more than once per year. It looks to me like the patients would need booster shots once every 6 months or thereabouts. I don't think that having booster shots every 6 months is a big problem but I am concerned about safety issues now. The safety profile has changed more dramatically even than the efficacy profile IMO.





Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.

Originally Posted by jarjarbinx


Originally Posted by hairman2


Originally Posted by jarjarbinx





hairman2 is located in [NA] and he is available to meet: NO


Post reply
hairman2

01.06.2013, 15:10

@ jarjarbinx

HISTOGEN FAILS

There are several things which are bad.... one being that the total increase in hair count was 2.5% in the frontal area... they basically only managed to turn some vellus hair into terminal hair.

To be fair it seems histogen raised the bar as to when hair is considered to be terminal from 30 to 40 microns diameter since their previous results. The increased threshold of course reduces the amount of hair which can be considered terminal.

Another problem being that results deteriorate after just a few months despite jarjar's claims of "turning back the hands of time" (whatever that even means :rotfl: ) and there being no proof that the revived hairs would be still be susceptible to AGA.

[source] http://www.hairsite.com/hair-loss/forum_entry-id-118187-page-1-category-1-order-last_answer.html

[quote from jarjar the IQ 120 genius]
Question: What scientific study proved that the hair "won't stay" with Aderans or Histogen?

Answer: NONE
[end quote]

Wait a second. We're jumping the gun here. The more I think about this the more I'm thinking that we need more information before we form a conclusion as to whether or not this is good or bad news.

There were hemoglobin count changes but how long does it take for the hemoglobin count to revert back to baseline, and how big were the hemoglobin count changes? If the changes were minor to mild, and if the changes went back to baseline in days or a week or a month, then this is not a major problem. If the hemoglobin count change was small to mild and if the change reverted back to baseline with a month then this is a minor problem




Originally Posted by AleMB81

This is not a good news for anyone :\ one weapon gone :\

Originally Posted by jarjarbinx





hairman2 is located in [NA] and he is available to meet: NO


Post reply
Mr. Z

01.06.2013, 15:52

@ hairman2

HISTOGEN FAILS

The hair regrowth percentages are not good. I wouldn't say they're terrible, probably in line with propecia. Which, in the grand scheme of things, a treatment which could replace propecia would be a great thing. If a patient could halt the hair loss for a year,and get some regrowth out of it - i think it would be an amazing new treatment and light years better than anything on the market.

But, the real problem is the confluence of fleeting results and toxicity. Together, they put the nail in the coffin for Histogen. I would imagine increased haemoglobin counts will be extremely dangerous for older patients or younger ones with potential issues and would put the company at risk for any patient who takes their product and has a cardiovascular event e.g. stroke or heart attack. Eventually, someone taking histogen will have a heart attack and whether related to the treatment or not, Histogen would take the fall for it. No way any investors would open themselves to that kind of risk.

They're not going to get any more money on this, IMO. Which is why they've been quiet for so long. I've been on these boards for a long time, and anytime a company completes a trial and goes quiet (cough ***Aderans*** cough) it's indicative of unanticipated negative or unimpressive results. Histogen is finished.

I'm sad, as i think these guys were the last hope for those of us in the 30/40+ age bracket. I also believe Aderans is done. Follica is dead. And quite frankly, i don't care that Replicel found some company to float them money...they still haven't demonstrated proof that they can grow appreciable amounts of hair safely. Even if they can grow hair better than they've shown, they are a looooongggg way off, 5+ years.

I guess it's time to come to terms with baldness, it's here to stay.:-(




Mr. Z is located in [NA] and he is available to meet: NO


Post reply
hairman2

01.06.2013, 16:03

@ Mr. Z

HISTOGEN FAILS

hemoglobin was decreased not increased.

I too could imagine that the decrease in hemoglobin could pose a risk to certain people which would require for patients to have their blood results monitored while under HSC treatment rendering the procedure even more expensive than it already is. Not to mention that the FDA will have to be satisfied that the hemoglobin risk is an acceptable risk for a cosmetic treatment.

I agree that this just might be the nail in the coffin of histogen, as you put it.

I wonder however if HSC would be beneficial in conjunction with aderans. Perhaps the improved growth factor environment could help promote the results from aderans' injections.

Originally Posted by Mr. Z

The hair regrowth percentages are not good. I wouldn't say they're terrible, probably in line with propecia. Which, in the grand scheme of things, a treatment which could replace propecia would be a great thing. If a patient could halt the hair loss for a year,and get some regrowth out of it - i think it would be an amazing new treatment and light years better than anything on the market.

But, the real problem is the confluence of fleeting results and toxicity. Together, they put the nail in the coffin for Histogen. I would imagine increased haemoglobin counts will be extremely dangerous for older patients or younger ones with potential issues and would put the company at risk for any patient who takes their product and has a cardiovascular event e.g. stroke or heart attack. Eventually, someone taking histogen will have a heart attack and whether related to the treatment or not, Histogen would take the fall for it. No way any investors would open themselves to that kind of risk.

They're not going to get any more money on this, IMO. Which is why they've been quiet for so long. I've been on these boards for a long time, and anytime a company completes a trial and goes quiet (cough ***Aderans*** cough) it's indicative of unanticipated negative or unimpressive results. Histogen is finished.

I'm sad, as i think these guys were the last hope for those of us in the 30/40+ age bracket. I also believe Aderans is done. Follica is dead. And quite frankly, i don't care that Replicel found some company to float them money...they still haven't demonstrated proof that they can grow appreciable amounts of hair safely. Even if they can grow hair better than they've shown, they are a looooongggg way off, 5+ years.

I guess it's time to come to terms with baldness, it's here to stay.:-(





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Post reply
Mr. Z

01.06.2013, 16:12
(edited by Mr. Z, 01.06.2013, 16:38)

@ hairman2

HISTOGEN FAILS

decreased. Ok, i read that wrong...my apologies. it's still not good.

Heamoglobin increased back to normal when the used antibodies to Follistatin. I was looking at the wrong line. The result of the rest of the toxicity panel looks good though. I don't know, maybe this is not as bad as my initial impression.

I think their hair growth looks decent. The decreases they were seeing in terminal hair count were in the temporal region which is a tough area to grow hair in for any treatment. Perhaps this would still work as a preventative treatment in the temples along with some hair growth in crown and a good increase in density of existing hairs...result might not be too bad.

But, the question mark is the haemoglobin and what that means for the patient. I doubt FDA would permit anything cosmetic with a change in CV parameter. Who knows, would love to hear Gail's comments on it.




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Post reply
jarjarbinx

01.06.2013, 16:26

@ hairman2

HISTOGEN FAILS (JARJAR A RETARD)

* I've already turned this post by you over to Hairsite asking that your childish name-calling text be deleted or else for the entire post to be deleted.

* Hairsite already deleted text from your last post because of your failure to post like an adult and to instead post like a rude child.

* Neither you nor Roger_that said anything about the hemoglobin count because the thought never crossed either of your minds. You can say you raised the issue of possible general toxicity and I agree that both of you did so, but if you say that you or Roger_that were concerned about the hemoglobin count that would be a lie.

* Now you can disagree with me if you want to because I've bestowed upon you the right to disagree with me. You are allowed to disagree with me if you want to so don't worry...be happy.



alas, again you are twisting the truth to make yourself look less like the fool that you are.

http://www.hairsite.com/hair-loss/forum_entry-id-118786.html
http://www.hairsite.com/hair-loss/forum_entry-id-115363.html
http://www.hairsite.com/hair-loss/forum_entry-id-115327.html

to quote roger:
- concerns about long-term toxicity or cancer induction.
- Obviously they are spacing the injections out VERY widely for a reason. My guess is that although not all of the ingredients are toxic and/or are linked to cancer


roger and I both spoke generally of the risk of toxicity ultimately potentially even INCLUDING risk of cancer but not LIMITED to cancer.

I can dig up more of my old posts later on that if you wish.

Normally I would say I'd be wasting my time by doing so but I think it is important to expose you for the sh*ttalker that you are.

* Your opinion is sh!t, but I do bestow upon you the right to have a sh!t opinion. Are we cool now? You can have all of the sh!t opinions that you want to have.

* I based my opinion on the results of the 1st study and the preliminary 1/11 study results. There was nothing unreasonable about that. Lots of other people agreed that Histogen looked very promising.

* Now that I have the new final 1/11 results I'm adjusting my posit accordingly. I think that Histogen's news is disappointing but I don't think the results means the treatment isn't viable. I think it could still be viable and it could still be a significant improvement over existing treatments.

1. It shows that the benefit of the treatment started to wear off after 36 weeks so booster shots would need to be done every 6 months. I don't see any problem with booster shots every 6 months.

2. We need more info about the hemoglobin count issue. We need to know how much the hemoglobin count changed, and how long it took after injection for the hemoglobin count to revert back to baseline. For all we know the change in hemoglobin count was minor and the hemoglobin count reverted back to baseline in a week or maybe even a day or two. If that is the case then we could have a decent amount of injections each session and sessions would only have to be 1 or 2 weeks apart. We need the specifics.

* I will notify Hairsite that your post needs to be edited for the childish name-calling in your post which will result in Hairsite having to censor some of your text.

* Neither you nor Roger_that said anything about hemoglobin count changes so you are taking credit for something you do not deserve. You and Roger-that expressed concerns about a potential cancer risk which still has not materialized so you and Roger-that are as wrong as I was.

*I'm done responding and will report your childish name-calling to Histogen so that your post can be edited as it should be.



he called you a "retard" for good reason in my opinion... mostly because you are one.

You have been proclaiming that the cure is here for months now, with absolutely nothing to back it up... even discouraging new research approaches because we already have a cure :D

you were equally enthusiastic about PGD2 blockers in the beginning, attacking everyone who dared to think differently. Now you did the same with histogen.. i wonder what will be next.

also, in your pathetically simple world... more is always better.. which is why you kept repeating like a rabies infested mongrel that repeat injections and higher doses will bring the cure.

You stubbornly refused to even consider the fact that there may be good reason why histogen is NOT applying injections every few weeks. roger_that (and I) pointed out this issue of toxicity numerous times as you know.

You refused to acknowledge that the figures provided by histogen were in strong contrast to what histogen showed us in patient pictures. There was very little improvement in the general appearance. This should have made you wonder, as it did for the rest of us.

Even the fact that histogen admitted to having trouble finding funding for their product didnt ring alarm bells for you. Naturally if there results were spectacular then they would not have any trouble getting funding.

But then again, i forget that you are "almost always right" in arguments :rotfl: I really wonder when you are going to wake up and realize how deluded you are.


You call me a "retard" as though I should have realized that that the treatment results would turn out as they did. A lot of people have been expecting Histogen's results to turn out better than they have.
And of course you act so superior as if 6 months ago you foresaw the results as they ended up. What a laugh. You're a blowhard.

That having been said. I'm surprised and by Histogen's results. I never would have imagined or expected this result. I thought for sure that Histogen would prove to be a blockbuster treatment. I don't get it. This result is totally different from their previous study result. This study result is a huge departure from their first study result.

And what about the initial early data release for this same study which showed obvious regrowth in the patients and there was a picture of a lady's result which showed what looked like total reversal of hair loss.

It looks to me like the treatment was wearing off by the 36th week so patients would need booster shots more than once per year. It looks to me like the patients would need booster shots once every 6 months or thereabouts. I don't think that having booster shots every 6 months is a big problem but I am concerned about safety issues now. The safety profile has changed more dramatically even than the efficacy profile IMO.





Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.

Originally Posted by jarjarbinx


Originally Posted by hairman2


Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
jarjarbinx

01.06.2013, 16:33

@ Mr. Z

HISTOGEN FAILS

You might be right that Histogen might drop their HSC treatment. Some drug companies over-react to this sort of news. I would say that it should depend on the degree of the change in the hemoglobin count and the duration of it and the percentage of people affected, but it's not my decision to make. There is hardly any medicine on the market that truly has NO risk so I do not think a minor reversible change in hemoglobin count should prevent the treatment from coming to market but again it's not my decision to make. I disagree about the efficacy issue because for all we know Histogen's treatment may still be compoundable. It would depend on how often it can be injected without causing the hemoglobin reaction to a significant degree. But it's not my decision to make. If it was my treatment I would pursue further, but it doesn't belong to me so I can't make that decision.


Originally Posted by Mr. Z

The hair regrowth percentages are not good. I wouldn't say they're terrible, probably in line with propecia. Which, in the grand scheme of things, a treatment which could replace propecia would be a great thing. If a patient could halt the hair loss for a year,and get some regrowth out of it - i think it would be an amazing new treatment and light years better than anything on the market.

But, the real problem is the confluence of fleeting results and toxicity. Together, they put the nail in the coffin for Histogen. I would imagine increased haemoglobin counts will be extremely dangerous for older patients or younger ones with potential issues and would put the company at risk for any patient who takes their product and has a cardiovascular event e.g. stroke or heart attack. Eventually, someone taking histogen will have a heart attack and whether related to the treatment or not, Histogen would take the fall for it. No way any investors would open themselves to that kind of risk.

They're not going to get any more money on this, IMO. Which is why they've been quiet for so long. I've been on these boards for a long time, and anytime a company completes a trial and goes quiet (cough ***Aderans*** cough) it's indicative of unanticipated negative or unimpressive results. Histogen is finished.

I'm sad, as i think these guys were the last hope for those of us in the 30/40+ age bracket. I also believe Aderans is done. Follica is dead. And quite frankly, i don't care that Replicel found some company to float them money...they still haven't demonstrated proof that they can grow appreciable amounts of hair safely. Even if they can grow hair better than they've shown, they are a looooongggg way off, 5+ years.

I guess it's time to come to terms with baldness, it's here to stay.:-(





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Post reply
hairman2

01.06.2013, 16:39

@ jarjarbinx

HISTOGEN FAILS

The main problem is that if even a single person has serious effects (or even death) due to the drop in hemoglobin counts, it would be an utter catastrophe for Histogen and the FDA. Which is why the FDA will carefully scrutinize this very aspect. They might even come to the conclusion that the risk is not acceptable for a cosmetic treatment. This is the major hurdle that I currently see in getting HSC to market.

You might be right that Histogen might drop their HSC treatment. Some drug companies over-react to this sort of news. I would say that it should depend on the degree of the change in the hemoglobin count and the duration of it and the percentage of people affected, but it's not my decision to make. There is hardly any medicine on the market that truly has NO risk so I do not think a minor reversible change in hemoglobin count should prevent the treatment from coming to market but again it's not my decision to make. I disagree about the efficacy issue because for all we know Histogen's treatment may still be compoundable. It would depend on how often it can be injected without causing the hemoglobin reaction to a significant degree. But it's not my decision to make. If it was my treatment I would pursue further, but it doesn't belong to me so I can't make that decision.


Originally Posted by Mr. Z

The hair regrowth percentages are not good. I wouldn't say they're terrible, probably in line with propecia. Which, in the grand scheme of things, a treatment which could replace propecia would be a great thing. If a patient could halt the hair loss for a year,and get some regrowth out of it - i think it would be an amazing new treatment and light years better than anything on the market.

But, the real problem is the confluence of fleeting results and toxicity. Together, they put the nail in the coffin for Histogen. I would imagine increased haemoglobin counts will be extremely dangerous for older patients or younger ones with potential issues and would put the company at risk for any patient who takes their product and has a cardiovascular event e.g. stroke or heart attack. Eventually, someone taking histogen will have a heart attack and whether related to the treatment or not, Histogen would take the fall for it. No way any investors would open themselves to that kind of risk.

They're not going to get any more money on this, IMO. Which is why they've been quiet for so long. I've been on these boards for a long time, and anytime a company completes a trial and goes quiet (cough ***Aderans*** cough) it's indicative of unanticipated negative or unimpressive results. Histogen is finished.

I'm sad, as i think these guys were the last hope for those of us in the 30/40+ age bracket. I also believe Aderans is done. Follica is dead. And quite frankly, i don't care that Replicel found some company to float them money...they still haven't demonstrated proof that they can grow appreciable amounts of hair safely. Even if they can grow hair better than they've shown, they are a looooongggg way off, 5+ years.

I guess it's time to come to terms with baldness, it's here to stay.:-(

Originally Posted by jarjarbinx





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Post reply
Mr. Z

01.06.2013, 16:44

@ jarjarbinx

HISTOGEN FAILS

I agree Jar.

I don't know what to think now...my initial reaction was probably overblown. The toxicity panel looked very good otherwise. And as far as i'm concerned the hair growth was not bad. Look at the photo...there is a very visible increase in the density of the exsiting hair. Plus, they did see growth in the temple region which is damn near impossible to achieve with other therapies.

The haemoglobin issue might very well be the end for them but, I will be very curious to hear Gail's comments on this issue.




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Post reply
jarjarbinx

01.06.2013, 17:12
(edited by jarjarbinx, 01.06.2013, 17:38)

@ Mr. Z

HISTOGEN FAILS

This could go either way. It depends on if Histogen over-reacts to the situation. They proved that as long as they don't use over a certain amount they didn't get a hemoglobin reaction, and that dose did have a beneficial effect, so that could mean that it is a viable treatment. Let me put it this way:

If they use "X" amount they will grow 25% more hair and there will be NO hemoglobin reaction. If they go over that amount there is a risk of a hemoglobin reaction, but they don't need to go higher than that dose to achieve a 25% increase in hair growth. This means a therapeutic dose is totally safe.

When you look at it like that doesn't it look like it could be a viable treatment? There are a lot of common drugs in the marketplace that have toxicity if you use too much. If you take too much aspirin it will kill you, but no reasonable person would say that aspirin should be taken off the shelves. I think Histogen should move forward with HSC but it's not my decision to make. I think it's a close call because 25% more hair is not that much more hair, and if they use more of the treatment (in one session) then they could get more hair growth, but that could cause the hemoglobin reaction

But if the hemoglobin reaction reverts to baseline after a few weeks or a month then Histogen should be looking at keeping the amount at the safe amount (to alleviate potential FDA concerns) but also look at repeat injections with the repeat injections happening after the hemoglobin reaction reverts back to baseline. So if the hemoglobin reaction takes 3 weeks to revert back to normal then they should do the treatments once a month until the patient gets his/her hair back and then after the patient gets his/her hair back maybe do the treatment once every 6 months for maintenance. But the thing is whether or not they will think of this or if they will over-react and kill the project due to the hemoglobin reaction. It really does not seem like sufficient reason to kill the project but drug companies make peculiar decisions sometimes. Like I said aspirin kills some people but they let aspirin be for sale OTC. I would not be scared to try Histogen.

I think that the risk of hemoglobin reaction looks like it might be manageable and there are no other really serious problems presenting. If I was Histogen I would move forward with it but I'm not Histogen. There's no telling how they will react to this. I think it would be a mistake but they could shut it down.
Also, the fact still remains that if you use it once every 6 months you can get 25% more hair and stop using minoxidil/propecia daily.



Originally Posted by Mr. Z

I agree Jar.

I don't know what to think now...my initial reaction was probably overblown. The toxicity panel looked very good otherwise. And as far as i'm concerned the hair growth was not bad. Look at the photo...there is a very visible increase in the density of the exsiting hair. Plus, they did see growth in the temple region which is damn near impossible to achieve with other therapies.

The haemoglobin issue might very well be the end for them but, I will be very curious to hear Gail's comments on this issue.





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Post reply
hairman2

01.06.2013, 18:46

@ jarjarbinx

HISTOGEN FAILS

It appears to be more like an FDA decision than a histogen decision.

This could go either way. It depends on if Histogen over-reacts to the situation. They proved that as long as they don't use over a certain amount they didn't get a hemoglobin reaction, and that dose did have a beneficial effect, so that could mean that it is a viable treatment. Let me put it this way:

If they use "X" amount they will grow 25% more hair and there will be NO hemoglobin reaction. If they go over that amount there is a risk of a hemoglobin reaction, but they don't need to go higher than that dose to achieve a 25% increase in hair growth. This means a therapeutic dose is totally safe.

When you look at it like that doesn't it look like it could be a viable treatment? There are a lot of common drugs in the marketplace that have toxicity if you use too much. If you take too much aspirin it will kill you, but no reasonable person would say that aspirin should be taken off the shelves. I think Histogen should move forward with HSC but it's not my decision to make. I think it's a close call because 25% more hair is not that much more hair, and if they use more of the treatment (in one session) then they could get more hair growth, but that could cause the hemoglobin reaction

But if the hemoglobin reaction reverts to baseline after a few weeks or a month then Histogen should be looking at keeping the amount at the safe amount (to alleviate potential FDA concerns) but also look at repeat injections with the repeat injections happening after the hemoglobin reaction reverts back to baseline. So if the hemoglobin reaction takes 3 weeks to revert back to normal then they should do the treatments once a month until the patient gets his/her hair back and then after the patient gets his/her hair back maybe do the treatment once every 6 months for maintenance. But the thing is whether or not they will think of this or if they will over-react and kill the project due to the hemoglobin reaction. It really does not seem like sufficient reason to kill the project but drug companies make peculiar decisions sometimes. Like I said aspirin kills some people but they let aspirin be for sale OTC. I would not be scared to try Histogen.

I think that the risk of hemoglobin reaction looks like it might be manageable and there are no other really serious problems presenting. If I was Histogen I would move forward with it but I'm not Histogen. There's no telling how they will react to this. I think it would be a mistake but they could shut it down.
Also, the fact still remains that if you use it once every 6 months you can get 25% more hair and stop using minoxidil/propecia daily.



Originally Posted by Mr. Z

I agree Jar.

I don't know what to think now...my initial reaction was probably overblown. The toxicity panel looked very good otherwise. And as far as i'm concerned the hair growth was not bad. Look at the photo...there is a very visible increase in the density of the exsiting hair. Plus, they did see growth in the temple region which is damn near impossible to achieve with other therapies.

The haemoglobin issue might very well be the end for them but, I will be very curious to hear Gail's comments on this issue.

Originally Posted by jarjarbinx





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Post reply
KO

01.06.2013, 21:03

@ hairman2

HISTOGEN FAILS

I don't see anywhere that hair counts decline after 12 weeks. Are you looking at Total or Terminal?


The results don't look that bad to me....Histogen wasn't going to be a magic bullet anyways, as some are thinking, but another good arrow in the quiver so to speak.




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Post reply
Franklin

01.06.2013, 21:47

@ KO

HISTOGEN FAILS

I agree!




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Post reply
jarjarbinx

01.06.2013, 22:30
(edited by jarjarbinx, 01.06.2013, 23:15)

@ hairman2

HISTOGEN FAILS

The news as it stands now is that you can use up to a certain amount of HSC in human beings without lowering the hemoglobin count, and that same amount of HSC yields a significant therapeutic effect. So this means the desired therapeutic effect can be achieved with a safe dose. If the news continues to be the same as this then I can't imagine why the FDA would refuse to let HSC into the marketplace. I think that the most the FDA would do is to advise against using more than that safe amount in one session.

If the FDA were to take all of the drugs off the market that produce a risky side effect if you use too much then I think that the overwhelming majority of the medicines in the American marketplace would be taken off the market. As far as I know 100% of medicines are dangerous if you keep increasing the dose. Sooner or later anything will kill you if you keep increasing your intake at one sitting. Too much water will kill you. Too much air will explode your lungs. Too much of anything will kill anybody as far as I know so if the FDA is going to reject any medicine that is risky if you take too much then that means that the FDA will take virtually ALL medicines off the market.

I can't imagine the FDA rejecting Histogen's HSC on the basis of Histogen's final phase 1/11 study results.



It appears to be more like an FDA decision than a histogen decision.

This could go either way. It depends on if Histogen over-reacts to the situation. They proved that as long as they don't use over a certain amount they didn't get a hemoglobin reaction, and that dose did have a beneficial effect, so that could mean that it is a viable treatment. Let me put it this way:

If they use "X" amount they will grow 25% more hair and there will be NO hemoglobin reaction. If they go over that amount there is a risk of a hemoglobin reaction, but they don't need to go higher than that dose to achieve a 25% increase in hair growth. This means a therapeutic dose is totally safe.

When you look at it like that doesn't it look like it could be a viable treatment? There are a lot of common drugs in the marketplace that have toxicity if you use too much. If you take too much aspirin it will kill you, but no reasonable person would say that aspirin should be taken off the shelves. I think Histogen should move forward with HSC but it's not my decision to make. I think it's a close call because 25% more hair is not that much more hair, and if they use more of the treatment (in one session) then they could get more hair growth, but that could cause the hemoglobin reaction

But if the hemoglobin reaction reverts to baseline after a few weeks or a month then Histogen should be looking at keeping the amount at the safe amount (to alleviate potential FDA concerns) but also look at repeat injections with the repeat injections happening after the hemoglobin reaction reverts back to baseline. So if the hemoglobin reaction takes 3 weeks to revert back to normal then they should do the treatments once a month until the patient gets his/her hair back and then after the patient gets his/her hair back maybe do the treatment once every 6 months for maintenance. But the thing is whether or not they will think of this or if they will over-react and kill the project due to the hemoglobin reaction. It really does not seem like sufficient reason to kill the project but drug companies make peculiar decisions sometimes. Like I said aspirin kills some people but they let aspirin be for sale OTC. I would not be scared to try Histogen.

I think that the risk of hemoglobin reaction looks like it might be manageable and there are no other really serious problems presenting. If I was Histogen I would move forward with it but I'm not Histogen. There's no telling how they will react to this. I think it would be a mistake but they could shut it down.
Also, the fact still remains that if you use it once every 6 months you can get 25% more hair and stop using minoxidil/propecia daily.



Originally Posted by Mr. Z

I agree Jar.

I don't know what to think now...my initial reaction was probably overblown. The toxicity panel looked very good otherwise. And as far as i'm concerned the hair growth was not bad. Look at the photo...there is a very visible increase in the density of the exsiting hair. Plus, they did see growth in the temple region which is damn near impossible to achieve with other therapies.

The haemoglobin issue might very well be the end for them but, I will be very curious to hear Gail's comments on this issue.

Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
KO

01.06.2013, 23:27

@ jarjarbinx

HISTOGEN FAILS

Where exactly do you see hemoglobin elevation?




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Post reply
jarjarbinx

01.06.2013, 23:40

@ KO

HISTOGEN FAILS

If I said hemoglobin elevation I meant to say hemoglobin reduction not elevation. I didn't actually see it myself other people are saying that a hemoglobin reduction was linked to the use of HSC but that the effect was transient and mild.


Originally Posted by KO

Where exactly do you see hemoglobin elevation?





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Post reply
jarjarbinx

02.06.2013, 01:14

@ Faker

HISTOGEN FAILS

We are NOT talking about grass here. We are talking about follicles here. Follicles and grass are so different that your comparison is impossible. However, I do agree that creating new follicles and implanting them is a reasonable objective but it will take longer to get our hands on than cell transplants an growth factor implants. They just need to keep working on all of these approaches.


Originally Posted by Faker

I guess I'm here to add my 2 cents in... I think the best shot we have at a cure is successfully multiplying and growing hair follicles. You just cant argue with physically putting more hair follicles on the head. Although medical advancements have been great people still don't realize how medically we are so far behind. I mean there is simple things we cant cure. Unless it's a total fluke I cant see having any medical therapy that will regrow all of our hair. I feel like we are at least 2-5 decades away from that kind of cure. When we can do this we will practically be able to cure anything we want.

Let me give a crazy analogy. Imagine a field of dead grass. Grass that has died years ago covered with dirt and so on. Imagine trying to scientifically get that grass to live again. Imagine trying to place the components necessary to bring life and reactivate that blade of grass. No I'm not talking about seeds, I'm talking about reactivating a dead blade of grass.

Now Imagine taking a healthy vibrant green living blade of grass and trying to manipulate it to grow more blades of grass while sustaining itself. I'm no expert but If I had the task of making one of these successful I would much rather prefer the latter.





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Post reply
jarjarbinx

02.06.2013, 01:22

@ hairman2

HISTOGEN FAILS

So then you're saying that you think that Histogen would likely see these results as sufficient to proceed, right? If that is what you're saying then I agree that Histogen should proceed because these results are NOT bad results.

25% new hair without having to use daily propecia and rub rogaine into your scalp twice a day is an improvement over the messiness and trouble of applying minoxidil, not to mention that minoxidil does have some risks and propecia can grow breasts on men and cause impotence in men. At 25% via topical injections twice yearly I think Histogen is a better mouse trap than the existing mouse traps (rogaine and propecia).

I also think that if they will bring HSC to market they might find that they can tweak it with other hair loss treatments, especially cellular treatments like Aderans, or tweak it by the docs giving out this treatment in different ways.



It appears to be more like an FDA decision than a histogen decision.

This could go either way. It depends on if Histogen over-reacts to the situation. They proved that as long as they don't use over a certain amount they didn't get a hemoglobin reaction, and that dose did have a beneficial effect, so that could mean that it is a viable treatment. Let me put it this way:

If they use "X" amount they will grow 25% more hair and there will be NO hemoglobin reaction. If they go over that amount there is a risk of a hemoglobin reaction, but they don't need to go higher than that dose to achieve a 25% increase in hair growth. This means a therapeutic dose is totally safe.

When you look at it like that doesn't it look like it could be a viable treatment? There are a lot of common drugs in the marketplace that have toxicity if you use too much. If you take too much aspirin it will kill you, but no reasonable person would say that aspirin should be taken off the shelves. I think Histogen should move forward with HSC but it's not my decision to make. I think it's a close call because 25% more hair is not that much more hair, and if they use more of the treatment (in one session) then they could get more hair growth, but that could cause the hemoglobin reaction

But if the hemoglobin reaction reverts to baseline after a few weeks or a month then Histogen should be looking at keeping the amount at the safe amount (to alleviate potential FDA concerns) but also look at repeat injections with the repeat injections happening after the hemoglobin reaction reverts back to baseline. So if the hemoglobin reaction takes 3 weeks to revert back to normal then they should do the treatments once a month until the patient gets his/her hair back and then after the patient gets his/her hair back maybe do the treatment once every 6 months for maintenance. But the thing is whether or not they will think of this or if they will over-react and kill the project due to the hemoglobin reaction. It really does not seem like sufficient reason to kill the project but drug companies make peculiar decisions sometimes. Like I said aspirin kills some people but they let aspirin be for sale OTC. I would not be scared to try Histogen.

I think that the risk of hemoglobin reaction looks like it might be manageable and there are no other really serious problems presenting. If I was Histogen I would move forward with it but I'm not Histogen. There's no telling how they will react to this. I think it would be a mistake but they could shut it down.
Also, the fact still remains that if you use it once every 6 months you can get 25% more hair and stop using minoxidil/propecia daily.



Originally Posted by Mr. Z

I agree Jar.

I don't know what to think now...my initial reaction was probably overblown. The toxicity panel looked very good otherwise. And as far as i'm concerned the hair growth was not bad. Look at the photo...there is a very visible increase in the density of the exsiting hair. Plus, they did see growth in the temple region which is damn near impossible to achieve with other therapies.

The haemoglobin issue might very well be the end for them but, I will be very curious to hear Gail's comments on this issue.

Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
GoneWithTheHair

Australia,
02.06.2013, 01:55

@ needhairasap

HISTOGEN FAILS

The title of this thread is totally misleading HISTOGEN HAVE NOT FAILED ANYTHING. Just because you had a preconceived expectation of results and they didn't match them, doesn't mean its a fail.

From the results pdf I read I cant see that much negative news at all. If there is a decline after so many weeks then you will just need top up shots. As for the safety issue im sure they will be able to come up with something to negate that too or make sure not too much is administered at once.

They can still tweak this in the next phase and we know that multiple shots increases results so please take a valium and relax guys.




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Post reply
KO

02.06.2013, 02:30

@ GoneWithTheHair

HISTOGEN FAILS

I don't see any decline. If you look at terminal hairs you see a rise, if you look at decline after 36 wks, it doesnt mean much, there was a decline from 12 to 24. What is important is to compare it to baseline, and see whether it holds up, rathern than checking week to week. This is not perfectly syncrhonized.




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Post reply
AntiNorwood

02.06.2013, 05:02

@ KO

HISTOGEN FAILS

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.




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Post reply
jarjarbinx

02.06.2013, 11:18

@ AntiNorwood

HISTOGEN FAILS

Histogen has proved that if you are willing to sit in a derm chair for an hour twice a year you will get to keep the hair you have plus you will get to have an additional 25% more hair.


Originally Posted by AntiNorwood

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.





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Post reply
hairman2

02.06.2013, 12:12

@ jarjarbinx

HISTOGEN FAILS

They have NOT proven that in the slightest.. the short term (1 year) improvement does not project to whether or not this will work after 5 years. Where have they proven that you will not still lose hair over time?

Again you are jumping to ridiculous conclusions.

Histogen has proved that if you are willing to sit in a derm chair for an hour twice a year you will get to keep the hair you have plus you will get to have an additional 25% more hair.


Originally Posted by AntiNorwood

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.

Originally Posted by jarjarbinx





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Post reply
jarjarbinx

02.06.2013, 12:17

@ hairman2

HISTOGEN FAILS

* Perhaps I'm jumping to conclusions this time

* Why would booster shots stop working?

* Keep in mind that they have already shown that at least one repeat injection results in more hair growth above and beyond the hair growth seen from a single injection date.

* And by the way, I do not know if the repeat injection study data is even included in their latest final phase 1/2 results. If it's not then it would be interesting to know how the repeat injection patients are doing with their results.



They have NOT proven that in the slightest.. the short term (1 year) improvement does not project to whether or not this will work after 5 years. Where have they proven that you will not still lose hair over time?

Again you are jumping to ridiculous conclusions.

Histogen has proved that if you are willing to sit in a derm chair for an hour twice a year you will get to keep the hair you have plus you will get to have an additional 25% more hair.


Originally Posted by AntiNorwood

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.

Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
hairman2

02.06.2013, 12:25

@ jarjarbinx

HISTOGEN FAILS

because we have a predisposition for our hair loss to progress over time. The amount of hair which can be recovered through HSC is limited, it might well be that as AGA progresses the improvements that HSC can achieve will decrease accordingly. There is NO experience on the aspect of long term use of "booster shots" (as you so eloquently put it).

Your conclusion that HSC will continue to work forever regardless of age and how prone your hair is to falling out over time is highly speculative to say the least.

* Why would booster shots stop working?

* Keep in mind that they have already shown that at least one repeat injection results in more hair growth above and beyond the hair growth seen from a single injection.

* And by the way, I do not know if the repeat injection study data is even included in their latest final phase 1/2 results. If it's not then it would be interesting to know how the repeat injection patients are doing with their results.


They have NOT proven that in the slightest.. the short term (1 year) improvement does not project to whether or not this will work after 5 years. Where have they proven that you will not still lose hair over time?

Again you are jumping to ridiculous conclusions.

Histogen has proved that if you are willing to sit in a derm chair for an hour twice a year you will get to keep the hair you have plus you will get to have an additional 25% more hair.


Originally Posted by AntiNorwood

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.

Originally Posted by jarjarbinx


Originally Posted by hairman2


Originally Posted by jarjarbinx





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Post reply
jarjarbinx

02.06.2013, 12:31
(edited by jarjarbinx, 02.06.2013, 13:12)

@ hairman2

HISTOGEN FAILS

You have a point there but then the only way to find out for certain is to use booster shots until you die and see if it works or not. So we won't really have the perfect answer to that question until the present generation dies off after having used it until they die off (if it becomes available at all, that is). In other words if you are waiting for the definitive answer based on irrefutable evidence then (if Histogen becomes available) you will get the answer to that question in about 40 or 50 years.

And really, doesn't that apply to any hair loss treatment? Do we really know with absolute certainty if any hair loss treatment is truly permanent or not? I don't think so. And if you follow that premise to its' logical conclusion then the entire search for a permanent hair loss solution is pointless and you would be better off coming to terms with baldness and accepting baldness since you can't be 100% sure that any treatment will give you back a permanent full head of hair anyway.

Are you aware that your point consists of a continuous loop featuring the absolute rejection of baldness and the quest for a permanent baldness cure, while at the same time understanding that the search for a baldness cure is pointless?


because we have a predisposition for our hair loss to progress over time. The amount of hair which can be recovered through HSC is limited, it might well be that as AGA progresses the improvements that HSC can achieve will decrease accordingly. There is NO experience on the aspect of long term use of "booster shots" (as you so eloquently put it).

Your conclusion that HSC will continue to work forever regardless of age and how prone your hair is to falling out over time is highly speculative to say the least.

* Why would booster shots stop working?

* Keep in mind that they have already shown that at least one repeat injection results in more hair growth above and beyond the hair growth seen from a single injection.

* And by the way, I do not know if the repeat injection study data is even included in their latest final phase 1/2 results. If it's not then it would be interesting to know how the repeat injection patients are doing with their results.


They have NOT proven that in the slightest.. the short term (1 year) improvement does not project to whether or not this will work after 5 years. Where have they proven that you will not still lose hair over time?

Again you are jumping to ridiculous conclusions.

Histogen has proved that if you are willing to sit in a derm chair for an hour twice a year you will get to keep the hair you have plus you will get to have an additional 25% more hair.


Originally Posted by AntiNorwood

failure is subjective and relative to ones original expectations.

many people will be satisfied with sitting in a dermatologists chair for an hour twice a year knowing that they will no longer loose any hair. Which is still to be proven may I add.

Originally Posted by jarjarbinx


Originally Posted by hairman2


Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
jarjarbinx

02.06.2013, 14:12
(edited by jarjarbinx, 02.06.2013, 14:54)

@ hairman2

HISTOGEN FAILS

In my previous post I meant to ask:

"Are you aware that your point consists of a continuous loop featuring the absolute rejection of baldness and the quest for a permanent baldness cure, while at the same time understanding that the search for a *permanent* baldness cure is pointless?"

I accidentally left out the word "permanent" the 2nd time when I originally posted this and it makes more sense with the word "permanent" in there the 2nd time where it belongs.




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Post reply
abcxyz

02.06.2013, 18:26

@ needhairasap

HISTOGEN FAILS

Did they remove the PDF file? I can't access the link :(




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---
Rogaine foam + Propecia + Nizoral 1% + Lysine
No longer use topical Dutas as of Nov 2007.


Post reply
jarjarbinx

02.06.2013, 18:47

@ abcxyz

HISTOGEN FAILS

Try this link:

http://www.histogen.com/downloads/iid_2013_hsc_final.pdf

I went hunting for the study and found it. I hope this link works for you.


Originally Posted by abcxyz

Did they remove the PDF file? I can't access the link :(





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Post reply
hairman2

03.06.2013, 03:49

@ jarjarbinx

HISTOGEN FAILS

it was on the front page of their website all along.. must have been quite a hunt


I went hunting for the study and found it. I hope this link works for you.

Originally Posted by jarjarbinx





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Post reply
jarjarbinx

03.06.2013, 14:25

@ hairman2

HISTOGEN FAILS

It wasn't there when I checked earlier. That having been said why is your comment even necessary? What does it add to the discussion? It adds nothing as is the case with your posts all too often.

it was on the front page of their website all along.. must have been quite a hunt


I went hunting for the study and found it. I hope this link works for you.

Originally Posted by jarjarbinx


Originally Posted by hairman2





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Post reply
jarjarbinx

06.06.2013, 18:32

@ needhairasap

HISTOGEN FAILS

I recently emailed Histogen asking them about the hemoglobin issue and I sent them copies of the post below (and another post) indicating that the hemoglobin count got dangerously low in the patients. Histogen replied that this is a complete misunderstanding of the data being presented. Histogen has given me an explanation and informed me that I can relay that explanation here in the forum and attribute it to Histogen. I will be doing this as soon as I can understand the explanation. It's kind of technical.




Originally Posted by needhairasap

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.





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