Stem Cell Meeting on the Mesa

[benjt]

As no one else said they would watch the stream, I did (but only track 2 with Histogen and RepliCel). As expected, nothing too interesting from RepliCel which is not surprising as they are only starting the phase 3 trials right now. Histogen, on the other hand, was quite interesting - they apparently manage regrowth independent of the baldness state of an area. No matter how bald you are, they will give full regrowth within only a matter of weeks.
I'll just copy my notes:

Histogen

• HSC +126% terminal hairs count
• Growth and new follicle formation even months after treatment, so no repeated injections needed -> one injection session, full regrowth all over head
• physician trial: 100% effectiveness, all 10 clients had full regrowth
• HSC gives regrowth independent of age and how long target areas suffered from baldness
• HSC regulated as a biologic
• no mention of when phase 3 trials will start (which is a bad sign); they might not be completely happy with their Phase 2 results (i.e., havent found the perfect dose yet which does give perfect full regrowth in just one application or they need to find the minimum dose which achieves full regrowth because of potential risks of Wnt7, s. below notes on Stanford)

Need help with this statement, what does it mean?

• HSC falls under FDA biologics regulation instead of drug regulation

Stanford

• General stem cell multiplication via Wnt3A
• applies to hair too, no mention of concrete product, but a study for hair regenration is being carried out right now (early phase, probably pre-clinical)
• According to the presenter, Wnts (in general) activate not only stem/pluripotent cells but ALSO carcinogenic ones, thus Wnt should not be injected directly into patient but ONLY used for ex-vivo cultivation - this might apply to Histogen's treatment, unfortunately. Does Histogen only use Wnt7 for cultivation, or do they directly inject Wnt7 into the scalp?
• 30 months till they can COMMENCE clinial trials so they are ages away from any practical treatment if I understood this part correctly - stream got stuck here

RepliCel

• new Japanese regulation, about to be passed by their parliament within the next few months: only phase 1 and 2 needed for regenerative medicine and stem cell treatments for market clearance, nothing else. This would mean that RepliCel could potentially offer their hair treatment in Japan before phase 3 finishes. Question is whether the phase 1 & 2 trials for clearance need to be conducted in Japan for that or not, which is maybe part of the reason why Shiseido runs Phase 1/2 trials now in parallel.

 

[2young2retire]

LIVE STREAMING DOESN’T BEGIN FOR TRACK 2 UNTIL 10:15AM PST do you own a time machine benjt?

- - - Updated - - -

if what you posted is true. then we need to celebrate it.
i m gona kiss your as s if it is true.


i wonder though what will all these hair transplant surgeons do now? offer for free? lol

 

[benjt]

LIVE STREAMING DOESN’T BEGIN FOR TRACK 2 UNTIL 10:15AM PST do you own a time machine benjt?

If by "time machine" you mean "a machine that displays the time", then yes. The presentations were yesterday.

i wonder though what will all these hair transplant surgeons do now? offer for free? lol

Unfortunately for us, they don't have to worry for quite a while. Histogen isn't even starting their Phase 3 trials anytime soon (so we got no idea when Histogen's HSC will be available at all), and RepliCel is only starting them now, making it at least 4 years till RCH available. And as I gathered from one investor report, even once RCH is available there will initally be only very few doctors globally who can carry out the treatment, so it will be another few years till its finally everybody's turn.

In essence, the cure has been found. Our biggest issue (and, if the foundation idea works out, its biggest priority) is when these treatments will be finally available.

 

[2bald2young]

So hsc is the cure or something?

 

[2young2retire]

benjt

my predictions go as follow

in two years fue will become more like fue +regen and prices will go further down.

before 2020 we will be able to restore nw7 to nw0 with combination of treatments.

cb will finaly make its way. and we ll know for sure for sides about it.


so what i see as left is to do everything one can to maintain.

i also wonder what those prp studies will bring out.

 

[Python]

Well the cure does look like its very far away from us due yo funding. Just to be clear, if we do go through with the foundation, would we be better off investing in replicil, histogen or both?

This is still very good news nonetheless. The part where it falls under the biological area instead of drugs, I would assume is for regulations purposes. So it will mean the amount of hurdles they will have to go through before getting through the FDA. I am just hoping that biological is better then drug. I was going to watch it but when I realized when it was, it was too late.

 

[benjt]

So hsc is the cure or something?

As far as I can tell, both RepliCel's RCH and Histogen's HSC are "the cure". Histogen is more efficient (i.e. only one session for full regrowth, independent of how bald you are as it seems), but its safety profile may be not as good (Wnt risks - I still have to dig into that) and, most importantly, we don't even know when HSC will be available. Given how they don't even have a starting date for their phase 3 trials, this could be anywhere bweteen "in 6 years" and "in 15 years".

RepliCel's RCH, on the other hand, definitely has no safety problems (still need to check whether HSC has) and it is closer to actually being available. Last estimate was Q4 2019. On the other hand, you might need multiple treatments but they're currently finding out in their Phase 3 trials. In Phase 2, they managed to give 11 to 14% regrowth on average - but with a single injection, which is quite impressive. In Phase 3, they now try a 90 injection protocol. Some investment analyst said that 50% regrowth in one treatment session is realistic, so - if his info, which was before Phase 3 though - is correct, you would need at most two treatment sessions. If the 90 injection protocol turns out better than expected, RCH might be just as good as HSC in terms of regrowth.

if we do go through with the foundation, would we be better off investing in replicil, histogen or both?

Frankly, I don't know. Histogen definitely gives full regrowth in just one treatment session, but they don't even have an estimate when their treatment will be available. The most optimistic case would be 4 years from the start of phase 3 trials - but they don't even know when phase 3 trials will start. Question is whether this delay is due to a lack of funding (RepliCel have released their estimate for Phase 3 trial costs and that was around 2 to 2.5 million USD, if I remember correctly). If so, it would make sense to give them money so they can finally get things going again. As I stated in another thread, they were already right before phase 3 trials before some a**h** decided to sue them which ate up all their capital.

RepliCel, on the other hand, is already starting Phase 3 trials. They too, however, have a financing problem. Only raised 3 million in capital in the last financing round and already need 2 to 2.5 of that just for RCH Phase 3, but they still need to pay their people, for equipment, and so forth AND they also have other treatments for which they need to run trials. The big advantage here is that market availability is at least in sight for RCH, while for HSC it's not.

So, I don't know. Personally, I favor RepliCel simply because of their treatment being available sooner which we could maybe accelerate even further. After all, we want our hair back while we are still "young" (or, rather: younger than if we wait for Histogen). I don't care about Histogen giving full regrowth from NW7 when I'm 40 years, if I could instead make sure that RepliCel's RCH is available in my twenties, even if it requires two treatment sessions (or even three - it would still be quicker than Histogen). But just my personal opinion. I'd rather have to go in for treatment two or three times in 2020 and have hair sooner than go in once in 2025 or 2030.

 

[Notcoolanymore]

• According to the presenter, Wnts (in general) activate not only stem/pluripotent cells but ALSO carcinogenic ones, thus Wnt should not be injected directly into patient but ONLY used for ex-vivo cultivation - this might apply to Histogen's treatment, unfortunately. Does Histogen only use Wnt7 for cultivation, or do they directly inject Wnt7 into the scalp?

Looks like Histogen made some serious progress. The statement above is a little troubling though. If I understand correctly, the "cure" as it currently is constructed can cause cancer. It may be a while before they are able to test this on human subjects. Good news that they are making progress, but this is still a fews years away.

 

[benjt]

They have tested it on human subjects, as I wrote, with full regrowth.

Also, I am not sure if it does cause cancer. Stanford avoids the cancer problem by applying Wnt only in ex-vivo cultivation. We need to find out whether HSC contains Wnt7, or whether Wnt7 is only used to produce HSC. In the latter case, no cancer risks. Also, if the risk for cancer is quite low, I'd still be willing to use HSC. The way I understood the effect of Wnts regarding cancer, by the way, is that they don't cause new cancer to form but only to promote growth of already existing carcinogenic cells.


Edit: This website from 4 years ago states that HSC does contain Wnt7 directly.

So the next question is how high the risk actually is. If its negligible, oh well. If it was too high, they wouldn't be allowed to sell it anyway due to FDA regulations.

 

[EvilLocks]

They have tested it on human subjects, as I wrote, with full regrowth.

So ARE you saying that someone, a human, got FULL regrowth on Histogen as a test subject? If so, where do we sign up to be a test subject?!! I voulenteer as tribute!!

 

[2young2retire]

yes they did. now that is proof of concept

 

[benjt]

So ARE you saying that someone, a human, got FULL regrowth on Histogen as a test subject? If so, where do we sign up to be a test subject?!! I voulenteer as tribute!!

Yes, that is what I'm saying. And as Histogen doesn't know when the next phase of trials will start, there are no trials to sign up for on the horizon. Also, as far as I know the last trials were in Manila in the Philippines.
Have a look at the photos in this post, which are quite old though but still impressive given how much was achieved in how little time.

Also, don't disregard RepliCel. They have progressed further than Histogen, i.e. are starting phase 3 now. Already a single injection provided between 11 and 14% density increase on average and they are now testing a 90 injection protocol.

 

[2young2retire]

so 90 times more seems like at least 3 times the result for me. at least. the same goes with everything we put as a topical.

 

[Python]

I wouldn't want to wait 10 more years either. So our best bet will probably be replicel. Even if HSC seems like a much more preferred option. We're just going to have to pitch replicel to the community. But since the treatment for replicel could cure any type of hair loss, this will make it easier to pitch across the board.

 

[2young2retire]

i wonder what a combination could achieve.

 

[EvilLocks]

Also, don't disregard RepliCel. They have progressed further than Histogen, i.e. are starting phase 3 now. Already a single injection provided between 11 and 14% density increase on average and they are now testing a 90 injection protocol.

What do they do in these trials? And how long do you think phase 3 will last, and after that how long until available?

Also, I wouldn't mind travelling to the depths of hell if that got my hair back so if it is in the phillippines or next to my house does not matter. I want my hair back above all. But most likely I would not have been picked to be a test subject anyway

 

[hellouser]

What do they do in these trials? And how long do you think phase 3 will last, and after that how long until available?

Also, I wouldn't mind travelling to the depths of hell if that got my hair back so if it is in the phillippines or next to my house does not matter. I want my hair back above all. But most likely I would not have been picked to be a test subject anyway

Japan's new regulations allow for conditional release of a treatment DURING phase II trials. Keep your fingers crossed Shiseido takes advantage of this... if this happens you'll soon be able to have the life you deserve

 

[brunobald]

I guessing there were no pics...

 

[benjt]

I wouldn't want to wait 10 more years either. So our best bet will probably be replicel.

As tembo just pointed out, I was wrong; they are just starting Phase 2b and not Phase 3 :-/ so trials-wise, they are on par.

What do they do in these trials? And how long do you think phase 3 will last, and after that how long until available?

Unfortunately, not Phase 3 after all (my bad, sorry). Phase 3 is the last study you need before you can bring it on the market.
Currently, they are running 2b which is the dose finding trials. 2b will run for 2 years. After that, however, they still need Phase 3. And I don't know how long Phase 3 usually takes, but Wikipedia says also about 2 years. Wikipedia continues to say that FDA approval takes 1.5 years on average. So, there you got your schedule if everything goes according to plan: 5.5 years for the US of A and for the EU, cause the processes here are pretty much the same. This would make it 2021. And then please consider that RepliCel themselves say that only very few hair clinics will initially offer treatment, so the chances for receiving it right when its available are quite low.

Also, I wouldn't mind travelling to the depths of hell if that got my hair back so if it is in the phillippines or next to my house does not matter.

Trial enrolment for RepliCel's Phase 2b is over anyway. Primary site is Berlin, Germany. You'd need to reside there for the whole duration of the trials for regular checkups.

Japan's new regulations allow for conditional release of a treatment DURING phase II trials. Keep your fingers crossed Shiseido takes advantage of this... if this happens you'll soon be able to have the life you deserve

Let's hope. Given that RepliCel are not starting Phase 3 but 2b, Japan would be our only option there.

I am really wondering where RepliCel's estimate of treatment availability in Q4 2019 came from (which was removed from their website meanwhile). Let's see what Future_HT_Doc's inquiry holds.

I guessing there were no pics...

Nope, not during the presentation at least. But the ones I linked above are from the physician's trial in his practice and are still rather impressive.

 

[hellouser]

As tembo just pointed out, I was wrong; they are just starting Phase 2b and not Phase 3 :-/ so trials-wise, they are on par.



Unfortunately, not Phase 3 after all (my bad, sorry). Phase 3 is the last study you need before you can bring it on the market.
Currently, they are running 2b which is the dose finding trials. 2b will run for 2 years. After that, however, they still need Phase 3. And I don't know how long Phase 3 usually takes, but Wikipedia says also about 2 years. Wikipedia continues to say that FDA approval takes 1.5 years on average. So, there you got your schedule if everything goes according to plan: 5.5 years for the US of A and for the EU, cause the processes here are pretty much the same.

That is truly dreadful. I feel sorry for Americans... a little less for Europeans.