RepliCel: Current state

[EvilLocks]

This FDA bashing is complete BS, but its a "trend" on these forums. Its so much easier when you can blame others as it seems; much easier than to accept that right now there is nothing that can be done (except for lobbying for more money for research, I recently made a post about how little money is supplied for biology research, s. this post if interested). Have a look at the history of medication f*ck ups in the past due to insufficient clinical trials: casualties, cancer, undocumented side-effects, crippled babies because your fertility and DNA got f*cked up and what not. The clinical trial protocols for market clearance are almost identical among all western countries (i.e. the FDA is no worse than European authorities) and I totally support that rigidity as a general course of action even though it might suck for me personally. But hey... scientist bashing, FDA bashing, all the same as long as people can find something to rant about and someone to blame. Its so great when somebody else is at fault.

I'm not BLAMING the FDA or other authorities for the lack of a cure (and I don't think anyone else is either), my point was just that if the cure for hair loss was suddenly discovered today or tomorrow, it would still have to go through years of trials to reach the masses. Before that my youth and remaining hair will be gone. This is the point, most of us on here don't have the TIME to wait for clinical trials to be done. I still UNDERSTAND why it must be done (although I'm not sure why it must take so many years to be deemed safe or not, but hey I'm no researcher), it's just that it sucks so much having to wait all this time when I don't have it. I hope you understand I am not trying to blame the FDA. It's just very frustrating when I see my youth and hair going away little by little without any real treatment available.

 

[Muzzle]

But hey... scientist bashing, FDA bashing, all the same as long as people can find something to rant about and someone to blame. Its so great when somebody else is at fault.

I know people will be mad at me but i just love to do this


Hair loss treatmens in 90's:



Wolfenstein in 90's :




Hair loss treatments in 2014:



Wolfenstein in 2014 :

 

[benjt]

It's true, no doubt about it, it just doesn't have much to do with the FDA. It has much more to do with research funding.

@EvilLocks: I didn't refer to you with that. There are a few people on these forums, though, whose favorite hobby exactly that is.

 

[benjt]

More updates on RepliCel. Source is an old investor report by NBT.

• DSC cultivation cost for one round of treatment: 15,000 USD
• Estimated procedure cost (includes staff training and licensing costs which have to be passed on to clients): 5,000 to 15,000 USD, value more likely closer to 5,000 USD than to 15,000 USD in the long run. When treatment is available, it is easier to charge 15,000 USD as people will be willing to pay that. Procedure needs to be performed by qualified physician as biopsy is required for DSC cell extraction.
• Minimum avg. regrowth for a single injection treatment session in treated area: 11% acc. to phase I/IIa data, optimized single-injection dose supposedly 20%
• Maximum avg. regrowth for a multi-injection treatment session in treated area: 50% (this will hopefully become the standard protocol)
• Expected no. of licensed practitioners globally in first year of market availability: 6 (! this is obviously going to be the bottle neck !); 48 after 4 years

So there you got the data for something that looks like "the cure". Assuming that the multi-injection treatment becomes the standard protocol, you can regrow 50% of your hair in one treatment "session" (actually consists of two sessions: first session biopsy, second session is injection of DSC cells after three months of bioreactor cultivation) which will cost you between 20,000 and 30,000 USD. The obvious bottleneck is going to be the number of globally licensed doctors within the first year after treatment availability with only 6.
So even if they manage to get their treatment available by Q4 2019 (last official plans), you will need 30,000 USD for one round of treatment (hotel and flight cost excluded; remember that you will need flights twice) and you need to be one of the lucky few to receive it. Waiting lists will be long. Anyone with a mostly bald head will probably need two treatment rounds, i.e., up to 60,000 USD. But that is the projected cost for full regrowth. And it is still questionable whether it will be available by Q4 2019, but it is certain that they have it.

So, for anyone who wagers waiting for "the cure", consider that they will likely not be ready on time (i.e. not make it by Q4 2019), that you will need 30,000 to 60,000 USD depending on the severity of your hairloss, and that even when treatment becomes available the chance of you receiving treatment soon is extremely low.

 

[Python]

More updates on RepliCel. Source is an old investor report by NBT.

• DSC cultivation cost for one round of treatment: 15,000 USD
• Estimated procedure cost (includes staff training and licensing costs which have to be passed on to clients): 5,000 to 15,000 USD, value more likely closer to 5,000 USD than to 15,000 USD in the long run. When treatment is available, it is easier to charge 15,000 USD as people will be willing to pay that. Procedure needs to be performed by qualified physician as biopsy is required for DSC cell extraction.
• Minimum avg. regrowth for a single injection treatment session in treated area: 11% acc. to phase I/IIa data, optimized single-injection dose supposedly 20%
• Maximum avg. regrowth for a multi-injection treatment session in treated area: 50% (this will hopefully become the standard protocol)
• Expected no. of licensed practitioners globally in first year of market availability: 6 (! this is obviously going to be the bottle neck !); 48 after 4 years

So there you got the data for something that looks like "the cure". Assuming that the multi-injection treatment becomes the standard protocol, you can regrow 50% of your hair in one treatment "session" (actually consists of two sessions: first session biopsy, second session is injection of DSC cells after three months of bioreactor cultivation) which will cost you between 20,000 and 30,000 USD. The obvious bottleneck is going to be the number of globally licensed doctors within the first year after treatment availability with only 6.
So even if they manage to get their treatment available by Q4 2019 (last official plans), you will need 30,000 USD for one round of treatment (hotel and flight cost excluded; remember that you will need flights twice) and you need to be one of the lucky few to receive it. Waiting lists will be long. Anyone with a mostly bald head will probably need two treatment rounds, i.e., up to 60,000 USD. But that is the projected cost for full regrowth. And it is still questionable whether it will be available by Q4 2019, but it is certain that they have it.

So, for anyone who wagers waiting for "the cure", consider that they will likely not be ready on time (i.e. not make it by Q4 2019), that you will need 30,000 to 60,000 USD depending on the severity of your hairloss, and that even when treatment becomes available the chance of you receiving treatment soon is extremely low.

Assuming we do bet 50% of regrowth, are we talking about 50% relative to the amount of hair you have now? Or 50% of hair before you had lost a lot of hair?

Cause if we have pretty bad hairloss, 50% of the current won't be enough. At least for some.

 

[Future_HT_Doc]

$30,000?? Wow, that seems very excessive. Did Histogen share any decent updates at the Mesa conference?

 

[hmm]

I know people will be mad at me but i just love to do this


Hair loss treatmens in 90's:
View attachment 27851 View attachment 27850


Wolfenstein in 90's :
View attachment 27852



Hair loss treatments in 2014:

View attachment 27851 View attachment 27850

Wolfenstein in 2014 :

View attachment 27854

View attachment 27855

Wolfenstein in the 90's was better love that game.

 

[2young2retire]

[h=3]The live webcast for the 2014 Stem Cell Meeting on the Mesa Partnering Forum will be available beginning at 8:00am PT on Tuesday, October 8.[/h]

$30,000?? Wow, that seems very excessive. Did Histogen share any decent updates at the Mesa conference?

 

[benjt]

Assuming we do bet 50% of regrowth, are we talking about 50% relative to the amount of hair you have now? Or 50% of hair before you had lost a lot of hair?

Not easy to say, because Phase I and II were, if I'm not mistaken, conducted on people with "mild but pronounced Androgenetic Alopecia", i.e. Norwood 3 and 4 mostly. The measurement of success with them, however, was relative to what they had in thecase of RepliCel. From the way RCH works, however, I think that the dependence on how much hair you have left is not too big. Examination showed that completely new follicles formed and existing ones were repaired. So even though gains were measured relative to existing hair, it doesn't mean that the actual effect is relative to existing hair too. They just needed to quantify somehow, esp. because they need to convince investors that their treatment is superior to minoxidil and finasteride (which is clearly is even with a single injection! one single injection provides more regrowth than years of minoxidil, and in phase 3 trials they will test a 90 injections approach).

Histogen's HSC has provenly given full regrowth independent of how bald the area was.

$30,000?? Wow, that seems very excessive. Did Histogen share any decent updates at the Mesa conference?

I'm not completely surprised. Rare goods are expensive, so they can demand that much. And they need to make money somehow, given that the cost of cultivation for one session is already 15,000 USD. So with these 15,000 USD on the cost side, they haven't made any earnings yet. It is obvious they need to ask for more. What I find worse, though, is the low number of trainedand licensed clinics, so even when treatment is available and even if you have the money there will be too few doctors to treat all the people who want to get it for years.

 

[hellouser]

Without a link to a source, that $30,000 figure is pure speculation. In fact, it's a wildly outrageous price point considering what David Hall said about the cost for the tendonosis treatment:

http://video.foxbusiness.com/v/3775771951001/new-fix-for-tendon-injuries/

At the end of it the host asks how much will it cost for the treatment of tendonosis, and David Hall gives a straight up answer 'this is probably going to be $3,000 to $5,000 dollars.'

Why would a similar treatment with nearly identical methods of biopsy and culturing cost 6-10 times as much?

 

[benjt]

hellouser, I gave the name of the investment analyst who received their numbers by asking RepliCel. You could have just googled for "NBT RepliCel filetypedf". The 30,000 USD is not listed in their report, but the single numbers are. Just add them. For example, the per-patient fee of 15,000 USD for DSC cell cultivation can be found on page 16.

But as you can't seem to google, there you got your link: http://www.nbtequitiesresearch.com/...EQUITY_GROUP_REPLICEL_LIFE_SCIENCE_REPORT.pdf

 

[hellouser]

hellouser, I gave the name of the investment analyst who received their numbers by asking RepliCel. You could have just googled for "NBT RepliCel filetypedf". The 30,000 USD is not listed in their report, but the single numbers are. Just add them. For example, the per-patient fee of 15,000 USD for DSC cell cultivation can be found on page 16.

But as you can't seem to google, there you got your link: http://www.nbtequitiesresearch.com/...EQUITY_GROUP_REPLICEL_LIFE_SCIENCE_REPORT.pdf

That article/analysis is more than 2 years old. Not sure the price is still the same considering my comment anyway about a similar procedure costing WAY less from Replicel. Regardless, that price is outrageous. Also, its not my job to google every point... you state the facts, you back them up. I'm not going to do your homework.

 

[benjt]

You should know that I always back my statements up when the source isn't easily locatable, for example research papers. I refrain from listing sources whenever a statement can be confirmed with less than 5 seconds of using Google. Do I also have to back up that androgens lead to male pattern baldness?

And I don't care whether 30,000 USD are outrageous or not (remember, people might need two treatment sessions making it 60,000). These are the most accurate and most recent confirmed numbers we have. As to why it is so much higher than the tendonosis treatment I can only guess, but maybe DSC cells are harder to cultivate. After all, it takes 3 months in a bioreactor, you need the correct matrix to grow it in, and so forth - cultivation time and environmental conditons such as matrix composition may be fundamentally different. But this is just a guess; this is a topic I am not knowledgeable about.

The only thing that could make a considerable difference is that at the time the report was made, RepliCel didn't have the Shiseido deal yet. Shiseido can likely grow your DSC cells much cheaper because they got bigger infrastructure, leading to synergy effects. But we will only find this out once Future_HT_Doc has contacted RepliCel about it.

 

[macbeth81]

er

The second of the two treatment groups will receive 90 (!) injections. And that is the interesting part. While we already knew from phase 1 that one injection with the dose used in P1 can lead to a density increase of up to 19% (one single injection!) and an average of 10-14% (depending on whether you factor in non-responders into the average), this will show whether multiple injections can gradually replenish the DSC cells even more than one injection.

Were are the details regarding Phase 2B? Is it 90 injections across all three, non-placebo injection sites? If so that is only 15 injections per site, and repeated after 90 days for a total of 30 injections. From what I saw of Phase 1/2a trials, they used 6 injections (not one) over a 2 cm[SUP]2[/SUP] area, containing 50-100 million DSC cells total (8-17 million DSC cells per injection). Are they changing the concentration per injection and the site area? I have seen them mentioning different dosages, so I am assuming that is referring to number of DSC cells per injection.

Also there are 500 dermal papillae cells in a healthy hair, not 500 dermal sheath cup cells. If they knew how many DSC cells it took to yield 500 DP cells then they would know how much to inject.

Finally, didn't Replicel issue a retraction regarding the NBT Equities report?

 

[EvilLocks]

Are results (I mean a full head of hair, not 10% more growth) guaranteed at that steep price? I think it would be outrageous to offer a treatment that didn't give full or at least near full regrowth.

 

[Rocklee]

I hope it works for all of us in a few years...
But i dont think so...
How often they tell us 'baldness is over'..,
but its not..

 

[slam1523]

So where exactly does histogen's HSC stand? I can't seem to find anything? If it has proven to give a full head why aren't they pursuing it more? Funding? I know they do have some bad sides, but are they what's stopping this?

 

[macbeth81]

HSC = Hair Stimulating Complex.

Probably money related. They were almost ruined by the SkinMedica lawsuit. Last year SkinMedica lost their appeal. From watching their Stem Cell meeting presentation last year their business plan is on releasing cosmetic products first to fund future projects. They released ReGenica (SkinMedica lawsuit was regarding) and earlier this year acquired CellCeuticals. More recently they partnered with JPGH to distribute CellCeuticals in Asia. So clearly they are still working the plan. These projects are generating revenue. Unfortunately, a lot of investors pulled out due to he lawsuit and probably had no interest until the appeals were over. I cannot blame them, HSC is high risk in itself. Hopefully now they are financially in order and can start moving forward with HSC. They are conducting Series B funding for $23 million. Unfortunately SkinMedica screwed us all on this one.

http://www.histogen.com/applications/hsc.htm

 

[HairShocka]

When do you guys estimate that Replicel will be available in Japan? From all the info I've read, it sounds like they're getting a head start because they can setup and advertise before the product is released?

 

[benjt]

@macbeth: Thanks for pointing it out. It is not a 90 injection protocol but only a second after 90 days. My bad. But their slides weren't exactly verbose which is why I misunderstood it. They said something along the lines of "Group 1: Day 1 injection; Group 2: Day 1 + 90 injections", which I misinterpreted as an initial injection and later 90 more injections. Even with a second injection, though, we will know if (and how) RCH scales.

Same for the 500 DSC cells: You are right, the number referred to DP cells. Again, thanks for correcting me.