Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

Wow! Out of nowhere haha. Thanks Doc Z

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Originally Posted by Hurts

We've known the cause for cancer for decades, yet there still isn't a proper cure. With hair loss, we kind of know the cause thanks to recent studies (I mean the faulty stem cell issue), we definiately dont know about hair as much as we do about cancer. So expecting a cure so would be a bit optimistic unfortunately :(

But I could be and probably am wrong.

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People always bring up cancer, I'm not a doc or scientist but it just don't seem like a good comparison. I assume cancer is way more complicated. Even a crap drug like Propecia has done wonders for people and studies for hair loss have been minimal. I hope it's not like cancer.

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Originally Posted by Hurts

We've known the cause for cancer for decades, yet there still isn't a proper cure. With hair loss, we kind of know the cause thanks to recent studies (I mean the faulty stem cell issue), we definiately dont know about hair as much as we do about cancer. So expecting a cure so would be a bit optimistic unfortunately :(

But I could be and probably am wrong.

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Have we "known the cause [of] cancer for decades"? We know some of the genes involved; we know what happens to cells, and some ways in which to try to target the neoplastic ones; we know a number of carcinogens. That's reallly about it, isn't it? We don't know exactly why cancer happens to spontaneously develop in people, and we haven't any sound measures of prophylaxis.

As for hairloss, I hear a lot about D.H.T., but I'd be surprised if that turned out to be the sole cause of androgenic alopecia: D.H.T. is an endogenous product of testosterone in all human beings, yet not all of them go bald; further, it hits all hair follicles, yet only some permanently disappear. Finasteride inhibits 5-alpha reductase, thus preventing the catalysis of testosterone to D.H.T., and it seems to do a pretty good job of it; yet Propecia hardly "halts" baldness, in most men — even when it works, it seems to just help slow it down.

Ultimately, I don't feel we know a tremendous amount about either of these two phenomena, yet, and that what we do know is of reasonable, but very limited, clinical utility.

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Originally Posted by Dr. Craig Ziering

2014/15 or as soon as possible

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So if all goes well there's no chance for 2013? I thought I remember hearing it was possible. I guess too much time was waisted and trials won't be done by that time, I'm assuming. Man I wish it was 2013.

I’m just as anxious as the next guy looking for a better treatment, however I have a hard time believing Histogen is wasting time, time is money after all, and I’m sure they would like to have a safe and effective product on the market sooner rather than later, in fact completing the trials in Asia proves this. Let’s hope it does not take too long to recruit study participants and that Dr. Ziering keeps us informed of the results as the study progresses.

I don't know why it would take time to recruit participants ... we would all help them tomorrow morning if we could.

I’m sure allot of us would like to help, however I’d suspect the criteria for clinical trials is quite strict. For example they may want to screen out anyone what may have something other than androgenic alopecia (other types of alopecia’s), certain age groups, certain NW patterns, pre-existing medical conditions, past treatments (Propecia, Minox, HT) and so on. They would also need to find participants that would not hold they liable if issues or complications were to arise.

That said I’d agree with you in general, it probably 'should not' take a long time, but things always seem to take longer than one would reasonably expect.

Well of course I want safety first, that's why I said assuming everything went well. I meant time wasted, like the problems they had financially. The trials were supposed to start in 2010. I just want everything to go well. Waiting sucks.

it just means it wont be ready by 2014/2015 lol. well at least we'll know if plucked cloning will work by end of this year.

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Originally Posted by Havok

it just means it wont be ready by 2014/2015 lol. well at least we'll know if plucked cloning will work by end of this year.

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Will we? Has Dr. Bernstein yet begun working on his study? Even if he has, I'd think it would be about halfway into 2012 before the results became available (that is, if the world doesn't end... — :cool:).

First of all i am sorry for my bad english :D

We know there are lots of baldness sufferer all over the world and lots of them seeking for a cure about it. And i think Histogen is the most popular hope among the alternatives. İmagine the year is 2015 and Histogen brought HSC on the market. This is going to create a huge demand about HSC? I wonder how will this huge demand be responded by Histogen? Will be long long queue for it that will make sufferers waiting for years? Is there any Project about this situation?

Thanks!

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Originally Posted by mavikabir85

First of all i am sorry for my bad english :D

We know there are lots of baldness sufferer all over the world and lots of them seeking for a cure about it. And i think Histogen is the most popular hope among the alternatives. İmagine the year is 2015 and Histogen brought HSC on the market. This is going to create a huge demand about HSC? I wonder how will this huge demand be responded by Histogen? Will be long long queue for it that will make sufferers waiting for years? Is there any Project about this situation?

Thanks!

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Disregarding any patents (as I am not aware if there are any or not) I am assuming that HSC would succomb to the market pressures that impact every other drug/product, however, something that offers a real treatment for hair loss, would bring unprecedented demand, the main reason why only a small percentage of people seek treatment is because there really aren’t many effective treatments on the market today.

There will also be other competitors, Aderans is also planning for 2014, Follica are also working on something, but for sure, from the way the concepts look, Histogen to me (as a consumer) looks the most attractive; 2 years with sustained new growth after ONE INJECTION? lol, and they've been good to us (the hair loss community), always keep us informed, give us updates and inform us about trials etc. I wish them all the very best of luck for June.

Seems Dr. Naughton is leaving her post as SDSU in order to focus on her role at Histogen, I would suggest this is a good sign.

http://www.signonsandiego.com/news/2...ess-dean-sdsu/

jop thats true. Prime Example of a business woman thats for sure

One more question for Dr. Ziering: what will be the balding-patterns of the fifty patients to be enrolled in Histogen's June, 2011 trial of H.S.C.? That is, do you intend to enroll men who are Norwood 7s or close to?

Thank you.

They should include all types of balding and even get a background on the patients. It would be nice to know how aggressive their balding is or was and that way we have a better idea on how well this will work on different types of balding.

I hope you're starting women trials also?

Dr. Ziering,

Being a younger guy with diffuse hairloss on top the treatment Histogen is presenting seems to be the best chance for me to get my original head of hair back. Before I say anything, I think I speak for many of us when I say that I appreciate the amount of work and attention you have given to this forum.

My question to you is if after the next trail Histogen finds the correct dosage and how many injections are necessary to bring patients back to having a full head of hair, why not release the product in a country that has more lax rules about bringing it to market and allow consumers who want it to get the product earlier? Many of us are diffusely thinning and time is a factor, this would give many of us a lot of hope to grow back our hair and help so many people get past this terrible problem that kills our self esteem at such a young age. If the board won't allow it, they won't allow it but Dr. Ziering you are someone who surely understands how hairloss devastates a younger guy as I'm sure you've seen many in your office seeking an answer, I think it would be great if you could at least present the idea to Histogen and see what they say. I personally think it's a win-win, Histogen makes more money earlier to conduct more research for a faster US market release and you give hope to many hair-loss sufferers who are struggling on a daily basis.

Thank You,
-KH

Mate. They're not going to rush a product that's not known to be 100% SAFE or proven to work untill they conduct stage 2 trials to confirm otherwise. Dr Ziering knows how balding men/women feel and has himself said MANY times on this forum, in this thread even, that he and his colleagues are doing their best to bring this product to market as soon as humanly possible. IF the product passes the trials, then it will be a matter of 1-2 years. There's no point writing posts that may potentially use up Dr. Ziering's limited forum-time (should he embark on writing answers to your questions) when there are many other questions more deserving of an answer than yours.

Hurts,

What I was implying is releasing the product after the phase 1/2 trail, after safety has been confirmed. That was the point of my post, not to cut out the phase 1/2 trials completely but rather to release the product somewhere else sooner after the 2nd trail has been completed. It was not meant to be disrespectful but as a request for him to bring up to the board, I feel like it makes a lot of sense actually. If safety and efficacy has been proven through the 1/2 trails , I think it makes total sense to release it in a place that has less restrictions, this should have no effect on its FDA approval in the States or in Asia. Again, I'm not saying to release it right now before proving safety in the upcoming trails in Asia, I'm saying prove safety and efficacy and release it afterward.

After phase 1 and 2 trials, what's next? How come it will take two yrs after that to get release? What happens in phase 3?

People need to stop saying that Histogen will give them ALL THEIR HAIR BACK. It won't.

Not trying to be funny or start an arguement but none of us really know yet what Histogen's capable of with their end product.

The stuff we do know is that it thickens existing hairs and also regrows new hairs with just one injection. You say it can't grow back all your hair but how can you know that yet? Who knows what they'll achieve with more than one injection and by tweeking the formular.

I wish people on these forums didn't have to put a downer on promising break throughs all the time. As I'm sure people have said before there has to be promise for this product else the investors would have pulled out and the company would have given up on it. We've just had re-assurance that the phase I/II trials are going ahead which means things are still good until something else happens, like the product doesn't ever get to phase III can't you just let people have their optimism.

As others have also said even if this does not grow back all your hair at least it could be used with another treatment such as a hair transplant to give people a full head of hair again.

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Originally Posted by KeepHoping

Hurts,

What I was implying is releasing the product after the phase 1/2 trail, after safety has been confirmed. That was the point of my post, not to cut out the phase 1/2 trials completely but rather to release the product somewhere else sooner after the 2nd trail has been completed. It was not meant to be disrespectful but as a request for him to bring up to the board, I feel like it makes a lot of sense actually. If safety and efficacy has been proven through the 1/2 trails , I think it makes total sense to release it in a place that has less restrictions, this should have no effect on its FDA approval in the States or in Asia. Again, I'm not saying to release it right now before proving safety in the upcoming trails in Asia, I'm saying prove safety and efficacy and release it afterward.

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it's just not going to be rushed mate. I feel your pain too.

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Originally Posted by Hurts

it's just not going to be rushed mate. I feel your pain too.

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I agree, we can't rush these things, otherwise they just will not pan out as we hoped, we have to have patience and let the researchers scrutinise this process.

Everyone involved in the study wants it to market as bad as you do, we are all hoping for a better treatment, we just have to hang on and be patient, it will come.

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Originally Posted by UK Boy

The stuff we do know is that it thickens existing hairs and also regrows new hairs with just one injection. You say it can't grow back all your hair but how can you know that yet? Who knows what they'll achieve with more than one injection and by tweeking the formular.

I wish people on these forums didn't have to put a downer on promising break throughs all the time. As I'm sure people have said before there has to be promise for this product else the investors would have pulled out and the company would have given up on it. We've just had re-assurance that the phase I/II trials are going ahead which means things are still good until something else happens, like the product doesn't ever get to phase III can't you just let people have their optimism.

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That's a good point, we have to acknowledge that we have just been given confirmation of phase I/II, focus on the positives I guess.

And I really believe there is something here, nobody has ever achieved this amount of growth before and had it last past the 2 year mark, it is truly revolutionary.

All I'm saying is with a product like Histogens that has already gone through a successful pre-clinical trial, with a serious phase 1/2 trail, the one starting soon, proving safety and efficacy I think it's totally reasonable for the company to think about releasing the product early in other countries without a doubt and I think it's a reasonable request for me to ask Dr. Ziering to present the idea to the company presidents, I'm not asking for him to hold a gun to their heads but present the idea to their board members and see what they say. Not only do you help the many people dealing with hairloss but the company will get huge gains to conduct furthur research to benefit more people, for hair and for other health issues.

I would urge you guys to think about this. 2 years after a successful pre-clinical trial showing significant regrowth from one injection with no adverse effects the hair grown is still present in the scalp, this is a huge discovery. Now if they prove with multiple injections over the entire balding scalp can reverse hair loss completely and result in huge regrowth with efficacy and safety why would it be out of the picture for potential consumers to press the company for an earlier release in another country?

Well i dont wann piss on the parade but its highly likely if they got the expected results with more injections, that they will release it sooner, at least as an expanded trial or so, with more people involved for less cash or so.

You know they could even release it today it would make a huge difference thats for sure

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Originally Posted by RichardDawkins

You know they could even release it today it would make a huge difference thats for sure

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You've said that before, and I have yet to contemplate how the hell you feel the company could, right now, release a product that hasn't even entered phase-I clinical trials.

Hi everybody,

I came across this forum while looking for some Histogen news on the internet. This thread is awesome, that's for sure...
The idea of bringing HSC to markeg earlier is great but unfortunately very unlikely. Just imagine headlines like "Mexicans used as guinea pigs to maximize profit for hair cloning company"...
However, please forgive me if this question is too trivial but does Histogen regrow hair only were you once had it? Or in other words, could you grow a mustache right on your forehead if you wanted to? This might be important if it comes to re-designing a hairline...

I think after proving safety and efficacy in a 1/2 trail and after the results from their pre-clinical trial it would be very safe and financially smart for the company to release it somewhere earlier. People could sign disclaimers or whatnot and get the treatment. If this upcoming trail proves safety then I would certainly get the treatment myself. I'm not really asking to debate this, I'm more asking if Dr. Ziering could just present the idea to Histogen's board to see what they think of the idea and hope it goes through, that's all. Don't you guys think it's worth a try? Work with me here, I do believe Dr. Ziering is a fantastic guy for coming on this forum and answering questions, I'm just presenting an idea to him and I hope he at least gives it a shot at the next meeting he has with Histogen.

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Originally Posted by HairTalk

You've said that before, and I have yet to contemplate how the hell you feel the company could, right now, release a product that hasn't even entered phase-I clinical trials.

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Lol my thoughts exactly.

I agree, releasing this early may be preemptive but after proving safety and efficacy in a phase 1/2 trail, it's totally reasonable. I also feel like the more potential consumers that push this the more likely they would be to keep the option in mind. It would not effect the products ability to become FDA approved in the US, Asia or Europe, they could still complete their trials as planned and get the next big FDA approved treatment for hairloss AND they would make a huge amount of money from consumers to help them complete their costly studies. The more people that support this idea, the better chance we have to get a product sooner, try and work with me if you can, don't be skeptical right off the bat, this IS feasible and I want to push for it in a respectful way because I really appreciate and respect the way Dr. Ziering has approached this forum and it's users, I'm just fed up with hairloss especially as a diffuse thinner where there aren't many options and want an option while I have most of follciles intact.

Don't just disregard and say "this won't happen" or "I doubt it can be rushed" at least try and work with me guys and lets respectfully ask Dr. Ziering to present the idea of an early release to Histogen, it can't hurt.

Honestly, why don't you just wait and see what kind of results it gives ... if you have to pay hundreds of dollars for injections that only give you a couple of hair back, I don't think I'd buy it.

I want a CURE for my baldness, I want my hair back, not just some patchy results. I want a product that will reverse the process of balding.

I'm really sceptical how this product can give a Norwood 7 a full head of hair back ... I'm just not as positive as you guys.

PS : Sorry for my english.

Mojo,

I believe this is the product that will reverse the miniturization process better than any other, believe me, what I'm saying over and over is to advocate for an early release if they produce results with EFFICACY and SAFETY in their upcoming trail. You have nothing to lose to advocate for an earlier release but hair. It's worth the effort and if anyone believes the same I think it would be worthy to step up and say so.

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Originally Posted by Mojo Risin

Honestly, why don't you just wait and see what kind of results it gives ... if you have to pay hundreds of dollars for injections that only give you a couple of hair back, I don't think I'd buy it.

I want a CURE for my baldness, I want my hair back, not just some patchy results. I want a product that will reverse the process of balding.

I'm really sceptical how this product can give a Norwood 7 a full head of hair back ... I'm just not as positive as you guys.

PS : Sorry for my english.

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Agreed; this is partly why I've asked Dr. Ziering whether the upcoming trial of H.S.C. will comprise subjects who show roughly a Norwood-VI class of baldness — I hope he answers.

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Originally Posted by KeepHoping

Mojo,

I believe this is the product that will reverse the miniturization process better than any other, believe me, what I'm saying over and over is to advocate for an early release if they produce results with EFFICACY and SAFETY in their upcoming trail. You have nothing to lose to advocate for an earlier release but hair. It's worth the effort and if anyone believes the same I think it would be worthy to step up and say so.

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I'm not sure what you mean, then, by advocating "early release." If the product passes safety and efficacy trials, of course it will come to market (barring an unforeseen problem getting it released). Until and unless that happens, it should not.

A cure for baldness? If that's the case, You should probably check in this forum once every 3 yrs or so. That's not going to happen any time soon. Literally reversing baldness from nw7 to full head is a long shot at this point. Now if Histogen has the ability to halt progression and thicken existing hair, that alone would be something great. You can create more density in existing hair and maybe work with that in combination with a HT or something. For those who are not that far on the NW scale may get some or most hair back. Still need to see what this thing can really do.

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Originally Posted by CVAZBAR

A cure for baldness? If that's the case, You should probably check in this forum once every 3 yrs or so. That's not going to happen any time soon. Literally reversing baldness from nw7 to full head is a long shot at this point. Now if Histogen has the ability to halt progression and thicken existing hair, that alone would be something great. You can create more density in existing hair and maybe work with that in combination with a HT or something. For those who are not that far on the NW scale may get some or most hair back. Still need to see what this thing can really do.

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Attachment 9601

I mean, if you look at their results ... if it's only this kind of result that you get, if you're bald, you'll still look pretty bald to me.

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Originally Posted by Mojo Risin

Attachment 9601

I mean, if you look at their results ... if it's only this kind of result that you get, if you're bald, you'll still look pretty bald to me.

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True but remember it was only one injection on a very small area. Maybe the size of a dime. What would happen if you inject the whole head? What about more potency? I mean they can try several things. We still need to see what this can really do.

What I mean by pushing for an earlier release is once phase 1/2 trails are completing proving that the product is safe and effective then they should release the product in countries that have less restrictions and continue on with their trials to have it released in Asia and the US afterward. Otherwise the consumers will have to wait through another long (1-2 years) phase 3 trail. I think this should be considered by Histogen, would bring in a lot of revenue to conduct more trails on more products as well as helping a lot of people in need out.