Replicel\'s presentation at the Waldorf Astoria (Phase II)

Stem cell; cell based hair therapy
21

» All this stuff about their motivation is irrelevant to us. The bottom line
» is their core idea failed to work.

Exactly. Who cares about the Waldorf Astoria? If someone would have a good solution he could even present it in a youth hostel around the corner and there wouldnt be need for a fancy location

22

The bottom line is in phase 1 they got 6.1% growth. A good number of respondents got close to 10% improvement.

If their results improve during efficacy Phase 2 testing and it is compoundable, they have a worthwhile treatment to bring to market.

23

» The bottom line is in phase 1 they got 6.1% growth. A good number of
» respondents got close to 10% improvement.

Are you forgetting how tiny the sample size was?

There were only 19 test subjects, and of those, 3 were disqualified because of a temperature error in the protocol.

The trial was double-blind, so that means that only half got the real injections.

That would be about 8 subjects who got the real injections and whose data is usable.

So “6.1%” of 8 is (maybe) 5 people who showed SOME hair growth.

Noticeably absent from all this is the following:

1) PHOTOS

2) An explanation of exactly how they defined “hair growth”. For all we know, an additional 3 vellus hairs could have been interpreted as “hair growth”, and would become part of the (maybe) 5 patients responding. What if all 4 or 5 “responders” were in this category?

This whole protocol, and especially the “RESULTS”, was a joke, and it’s even more of a joke that they’re touting it as a “success” in any way. And since the sample size was so small, the results are that much more likely to be statistically irrelevant.

By any measure, by any objective standard, they have proven precisely NOTHING and have engendered ZERO confidence in their procedure.

24

» Are you forgetting how tiny the sample size was?

If sample size was sufficient to show statistical significance, it’s all that matters. I don’t think it was so nothing can be said either way. Personally I don’t give much credence to small tests like these one way or another. But I’ll take 6.1% improvement any day if by phase 2 that’s all they get out of it.

If small sample sizes don’t prove anything as you claim, it follows they don’t disprove anything either.

» There were only 19 test subjects, and of those, 3 were disqualified because
» of a temperature error in the protocol.

I believe they were disqualified due to time. It looks longer than 48 hours or something for the cells to reach the test site. Supposedly, cells are only considered viable for a fixed amount of time.

» So “6.1%” of 8 is (maybe) 5 people who showed SOME hair growth.

If they can even grow 1% more hair and the results are permanent and compoundable, it is a treatment.

The fact is this works extremely well in mice. They need to figure out why and I’m hoping the genetically markers they intend to use for cell selection during replication will improve their results.

Till then the useless bantering is a waste of time until they get into phase 2 efficacy treatment.

25

If we got on dutasteride at age 18, it should in theory give us 5X the amount of time with our hair. If our hair was genetically meant to fall out in 5 years, we now have 25 years of extended play - unless there is some rather low threshold for testosterone inducing baldness.

I wish I knew this at the point I started losing my hair. Although dutasteride was not available then, I could have used finasteride. The problem is there is so much useless sh&t information & snake oil salesmen out there, it takes time to even find out what the real science is.

Kevin McElwee’s paper on curent treatment options for MPB

DHT binds to androgen receptors with five times the tenacity of testosterone and consequently has greater downstream activation potency.5 Two distinct forms of 5α reductase (types 1 and 2) differ in their tissue distribution; type 2 is most active in hair follicles, but both likely contribute to AGA.

26

» All this stuff about their motivation is irrelevant to us. The bottom line
» is their core idea failed to work.

Yep…keep in mind, Aderans has been doing exactly what Replicel is doing and who knows where they are. I’m very skeptical they could do what ARI couldn’t in a shorter time with fewer resources. Replicel’s claim to difference from ARI was that they were using “DSC” cells, but nowhere in the literature does anyone else recognize the distinction between them.

I still think their core idea has merit, but from the perspective of somebody waiting for treatments, yeah it needs a lot more development before we can even bring up the term “release date” with these cell-based treatments. Right now what we have to look forward to are PGE2 mimics like bim, and PGD2 suppressors like OC or w/e.

27

If our hair was genetically meant to fall
» out in 5 years, we now have 25 years of extended play

lool

28

» Yep…keep in mind, Aderans has been doing exactly what Replicel is doing
» and who knows where they are. I’m very skeptical they could do what ARI
» couldn’t in a shorter time with fewer resources. Replicel’s claim to
» difference from ARI was that they were using “DSC” cells, but nowhere in
» the literature does anyone else recognize the distinction between them.

I’m skeptical about Replicel now that their Phase I trials turned out to be a bust, but I think Replicel would respond to your assertion that “nowhere else in the literature does anyone else recognize” DSC cells, by saying that Dr. McElwee was the first and ONLY researcher to discover this sub-population of cells. That’s precisely the reason you don’t see them described or catalogued anywhere else in the literature.

My read on this is that they claim to be cherry-picking an extremely potent subtype of Dermal Papilla cells – they named these cells Dermal Sheath Cup cells because of their location in a particular part of the dermal papilla. They would say that overall, DP cells exhibit slight to moderate inductivity, whereas a specific sub-population of DP cells, which they call DSC cells, exhibit powerful inductivity.

Picture a Bell Curve of all DP cells. On average, their inductivity falls somewhere in the “fat” or middle part of the bell. The inductivity of DSC cells is way over to the right-hand side of the curve.

But nobody except Dr. McElwee ever discovered that because they were all always using heterogeneous (mixed) populations of DP cells. These mixed populations taken from the entire dermal papilla had some DSC cells in them of course, but most of them were non-DSC type cells, with much weaker inductivity, thus the AVERAGE inductivity of the cultures was always somewhat poor and unreliable.

I think they’d further argue that no one else has discovered these DSC cells because no one else ever thought to look. I think they’d argue that Dr. McElwee was the only researcher who bothered to subdivide niche populations of DP cells (based on criteria like location of origin) and was therefore the only one to actually find the DSC cells and understand their potency. I think they’d argue that since other researchers didn’t bother to subdivide all DP cells into subtypes, they didn’t discover that some are very weakly inductive, and some are powerfully inductive, and that you need a homogeneous culture of the most POWERFULLY inductive cells to reap the maximum benefits out of HM.

They haven’t proven this yet in humans, and from the Phase I results, it doesn’t look too good. But I think that would be their argument.

29

The process of hair growth and cycling occurs in human scalps all the time. Replicating this process cannot possibly be rocket science.

I don’t know why this process works so spectacularly in mice but not as well in humans. But it has to be something very straight forward.

I’m hopeful that the genetic markers they are evaluating to select cells might improve yields. They should use these markers all throughout their cell multiplication process to screen out the non-trichogenic cells each day of the 3 month long replication process.

30

» Picture a Bell Curve of all DP cells. On average, their inductivity falls
» somewhere in the “fat” or middle part of the bell. The inductivity of DSC
» cells is way over to the right-hand side of the curve.
»
» But nobody except Dr. McElwee ever discovered that because they were all
» always using heterogeneous (mixed) populations of DP cells. These mixed
» populations taken from the entire dermal papilla had some DSC cells in them
» of course, but most of them were non-DSC type cells, with much weaker
» inductivity, thus the AVERAGE inductivity of the cultures was always
» somewhat poor and unreliable.
»

If the DSC cell niche is indeed unique, why haven’t other researchers done any academic studies by isolating this group of cells? Many cell-culturing experiments have happened in the past 10 years, noone else has confirmed or built upon his findings.

31

» If the DSC cell niche is indeed unique, why haven’t other researchers done
» any academic studies by isolating this group of cells?

It doesn’t necessarily follow from the DSC line being unique (or being claimed to be unique) that other researchers will try to isolate the line. McElwee is just one researcher working from Western Canada and published one paper in 2003. Maybe his paper wasn’t noticed enough, maybe his peers didn’t take it entirely seriously, maybe they were too absorbed in their own projects. Maybe a lot of people read it and thought it was bunk. It could be a lot of things, but the point is, it didn’t happen.

But you can’t disprove (or prove) the validity of his findings by pointing to the fact that nobody has TRIED to replicate them.

32

Dr. Angela Christiano & Dr. Colin Jahoda teamed up and filed a patent for something similar recently.

METHODS FOR COMPACT AGGREGATION OF DERMAL CELLS

Abstract:

The invention provides for a method for aggregating dermal papilla cells or dermal sheath cells or a combination thereof…in suspension culture; and contacting the culture with an effective amount of an enzyme, wherein a substrate of the enzyme is an extracellular matrix molecule in the suspension culture, so as to aggregate dermal papilla cells or dermal sheath cells. The culture may be a hanging drop culture and the enzyme may be a hyaluronidase.

  1. The method of claim 4, wherein the hanging drop is cultured until expression of an inductivity marker gene is reduced.

  2. The method of claim 1 or 2, further comprising grafting the compact aggregate of cells into the skin of a subject.

Historical studies have described expression of CD44 and hyaluronan (HA) during early hair follicle morphogenesis. Through microarray analysis, we have uncovered new evidence that this mechanism may play a key role in formation of the dermal condensate.

Read more: METHODS FOR COMPACT AGGREGATION OF DERMAL CELLS - Patent application

The image is sideways, but note CD44 declines as more replication cycles of cells are carried out (log number of cells increases). Its being used as a marker of trichogenicity (lack thereof). Once it declines past a certain point, cells are no longer considered trichogenic.

20100303767_33.png1024×1320 38.4 KB

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» Dr. Angela Christiano & Dr. Colin Jahoda teamed up and filed a patent for
» something similar recently.
»
» ------
»

This is pretty consistent with what other groups have done before. Although this time, they’re not using epidermal/dermal cell mixtures, but going through a different method.

34

I believe Christiano has setup a company as well - not sure if its exclusively dedicated to the above or engages in general hair research.

I can’t remember the name however.

All this research & patents are great. But at the end of the day if nothing grows hair, it isn’t worth a fu&k.

Maybe they are all filing patents to be patent trolls down the line - to launch lawsuits against people who have actually discovered how to grow hair. That’s the impression I get when I see Cotserellis filing patents left & right on all kinds of subjects under the sun.

It would be a damn shame if all this ended up like Gho hype.

35

Youtube report from Dr. Jeff Donovan on Replicel about their recent presentation in the Czech Republic at the EADV conference. It’s some kind of major hair and skin pow wow for European states.

Also some info about L’oreal’s topical which is supposed to trick cells into growing hair.

36

» Dr. Angela Christiano & Dr. Colin Jahoda teamed up and filed a patent for
» something similar recently.

Wanna know what they patented? Its the missing nishe which is used for sucessfull Aderans or Histogen stuff. Which means the two guys above were clever, pretty clever.

Now they get money by only being smart.

But personally, to me it is no wonder that hair multiplication will come pretty soon. Its the easiest way to make easy money and benefit from other findings.

Two or four possible scenarios

  1. inject something with the nishe product

  2. extract grafts and multiply them in a lab then transplant them

  3. do it like Gho

  4. create follicles like team tokyo and transplant them

Brave new world, brave new world. No wonder that stem cells are becoming more and more prominent. Also Jahoda and this girl are actually Gho supporters if you will. And they are even quoted by Histogen and Ari when they have key notes etc.

Three years top and we have something because the time span between tests andvisible results is becoming smaller and smaller. Especiall when you take a look at Japan hat they did there or when the injected balding cells from a human into mice and they grow hair, in normal patterns.

Well thats the painful problem here, we had to wait for so long because before that no easy money was involved. Take a look at Gho and his beginning, he fell flat on his face in the beginnings and it took him two decades or almost two decades to come to this point where we could say"with enough money everyone can be fixed"

Or Ari, there doing their thing since another decade and have only slow progress. Compare that to team tokyo who got good results in a very short time.

Unless you have a destroyed head with scars etc you shouldnt be orried about your future at all. But if you ask me, they should have come up with those things at least 4 years ago in 2008. This would be ok.

Anyway even Gho haters should at least thank Gho for pursuing HM all those years, because only becauseof his persistence and his high profile cases, HM has become much more focussed in the media

Believe me, without Gho and his attitude, we would all be screwed for good. Lets assume for one second no Wesley Sneijder and no Gerald Joling and no gcuk83.

Frightening, is it? And thats the sad point here, all those findings and upcoming things are based on two simple principles, which follicles can do

  1. regenerate themselves all the time

  2. stem cell nishes

Alopecia may be or is genetical BUT its not genetical in terms of what kind of nose or ears you get. This genetic predisposition is only connected with enzyms and stem cell interaction. If one thing in this process is stopped due to genetics, you can bypass it by manipulate it.

37

With all due respect, this is not the Gho forum. If you wanna talk about him then please go to his (Hair Stem Cell Transplantation) forum.

If you aren’t familiar with the history here then you may not understand why I am saying this. But we have had MAJOR problems in the past on this forum with a handful of Gho supporters. They were spamming up every non-Gho thread. It got so bad that they were literally trying to prevent us from being able to talk about anything else here. Hairsite finally created the Gho forum just to solve the issue.

38

It has taken an act of exorcism over many years to rid this forum of Gho.

Still no word from Cristiano & Jahoda on whether they have any intention of entering Phase I clinical trails of their patent.

39

» With all due respect, this is not the Gho forum. If you wanna talk about
» him then please go to his (Hair Stem Cell Transplantation) forum.
»
» If you aren’t familiar with the history here then you may not understand
» why I am saying this. But we have had MAJOR problems in the past on this
» forum with a handful of Gho supporters. They were spamming up every
» non-Gho thread. It got so bad that they were literally trying to prevent
» us from being able to talk about anything else here. Hairsite finally
» created the Gho forum just to solve the issue.

You’re talking to LeeroyStevieDeeChalston. He knows the scene