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Stem cell; cell based hair therapy
41

Im pretty sure you have followed this for a while too. I remember Washenik (or really Aderans) taking out a patent for bio-degradable tissue scaffolds assuring the public that it was to ensure proper direction. I wonder if there is any link between the scaffolds and the skin growing back over the inserted cells and any problems they forsee or worry about with this?

In some ways, Ive wondered if Aderans has (I know they have recruited for phase one tests) shot any man up and seen what happened. Thats what phase one’s do, see about safety. It would seem to me that men with the classic vertex bald spots would be the best one’s to test this on, but if you think about it, it could be tried in a one cm patch of skin anywhere on the dermis to see if the hair grew-------------and could be FUE’d right back out if any complications arose.

Obviously this must be uber complicated science.

BTW—I just finished reading a study that took place a few years back that culled vellus hairs from MPB men and put them on immuno-deficient mice, male and female…the vellus hairs actually outgrew donor-area hairs on the mice. There were pics and everything. We dont know the androgen levels in those mice, but that is interesting that enough stem cell material must be hanging around to generate that. The authors speculate some neuropeptide, cytokine, type of hormone, or whatever, must hang around in human skin and not allow for regeneration or for correct signalling even after one gets on finasteride.

42

You know Benji what baffles me is:

  1. Like you said why aren’t there any human clinical trials with this approach?
  2. Why not grow the patch of hair, cut the patch out, and then transplant the follicles for proper angles.
  3. The mouse models are specially genetically engineered mice, i.e. immunocompromised mice. So would humans be at risk for having an immune response such as a monoclonal antibody created towards any of the billions of antigens presented on these follicles grown in the patch?
  4. Was Washenik’s financial interest an influence on how much info he divulged today?

What do you think Benj?

43

» You know Benji what baffles me is:
»
» 1. Like you said why aren’t there any human clinical trials with this
» approach?
» 2. Why not grow the patch of hair, cut the patch out, and then transplant
» the follicles for proper angles.
» 3. The mouse models are specially genetically engineered mice, i.e.
» immunocompromised mice. So would humans be at risk for having an immune
» response such as a monoclonal antibody created towards any of the billions
» of antigens presented on these follicles grown in the patch?
» 4. Was Washenik’s financial interest an influence on how much info he
» divulged today?
»
» What do you think Benj?

  1. I keep thinking Aderans is about to kick off their phase one clinical trial. I mean ICX is in phase two, and if the results are pretty good, and Aderans hasn’t even started, they’d be pretty darn far behind unless they are purposely waiting to see what those results will be because they want to tweak their own protocol based on ICX’s results…

  2. Why not grow the patch oc hair, cut the patch out, and implant the hair? Ive been saying that for about three years. Back when “direction” was supposed to be the big problem with HM…I thought, “put it in my thigh, and when it grows out, FUE it out of my thigh to my head”.

  3. ON mice and men-------------ICX’s phase one didn’t have inflammation, but the only way Aderans would know for sure is to shoot two or three men up and see what they have up there.

  4. I dont know if Washenik was talking “up” the stock or talking it “down”. Admitting they are having a problem is honest though, I’ll give him that…

44

» 1. I keep thinking Aderans is about to kick off their phase one clinical
» trial. I mean ICX is in phase two, and if the results are pretty good, and
» Aderans hasn’t even started, they’d be pretty darn far behind unless they
» are purposely waiting to see what those results will be because they want
» to tweak their own protocol based on ICX’s results…

Hey benji/hairtech,

If you look at some of the earlier posts some folks on this forum emailed Aderans and the reply was that Phase I trials have already begun (that was a few months back). And if you believe the following press release then Aderans began its Phase I trials one year ago:
http://www.intermarkltd.com/ClinicalTrialPressRelease.htm

What baffles me is: why no data/info from Ken Washenik on Phase I, not even in terms of public relations? And why isn’t the press release on ARI’s website? And what does Washenik know about Intercytex (remember Bosley, which is owned by Aderans, has “exclusive” first rights to distribute ICX-TRC)? And what exactly is Aderans’ timeline (compare their lack of transparency with Intercytex, which is very clear about timelines)?

All the best,
BB

45

I’ll be honest too in saying that I have NOT followed HM that much since the days of BAZAN and his stuff. When I visited Jerry Cooley this year, he showed me the Intercytex stuff and that was compelling.

Then I see aderans/Washenik(essentially Bosley) two cell approach and was again compelled to start monitoring this stuff.

We are getting close fellas. But I have a problem. Bosley’s interest in speeding up research or if one wants to think in conspiracies… inhibiting research because again, he (Washenik), left us hanging.

Is it reasonable to say that given the fact that Bosley has a billion clinics, bought MHR which expands their clinics to a trillion… that it might be possible that they would not like this research to go through?

BB,

I agree with you!

46

» I’ll be honest too in saying that I have NOT followed HM that much since
» the days of BAZAN and his stuff. When I visited Jerry Cooley this year,
» he showed me the Intercytex stuff and that was compelling.
»
» Then I see aderans/Washenik(essentially Bosley) two cell approach and was
» again compelled to start monitoring this stuff.
»
» We are getting close fellas. But I have a problem. Bosley’s interest in
» speeding up research or if one wants to think in conspiracies…
» inhibiting research because again, he (Washenik), left us hanging.
»
» Is it reasonable to say that given the fact that Bosley has a billion
» clinics, bought MHR which expands their clinics to a trillion… that it
» might be possible that they would not like this research to go through?
»
» BB,
»
» I agree with you!

Thats no doubt true of Tom Bosley himself. In interviews he had been more than just skeptical of HM, he was downright hostile and aked “how much better does it have to be” when pointing at Ken Washenik, who has had five transplants.

However, Phoenixbio and Shishedo (Japanese companies) are now in the HM research game and both have patents in the art. Even if HM was somehow “smothered” by Bosley (owned by Aderans), one would think that ICX or the two Japanese companies would someday come out with it if it can be made to work. Bosley and MHR (can you believe anyone would allow MHR to actually touch their scalp? Egad the horror stories Ive read over the years from that bunch) probably could not keep buying out every little would-be HM start up. Id be suprised if that was what was going on with Aderans…Kurt Stenn would not be apartied to that in my opinion and he’d just flat leave the company. He is involved in Folica with Costarialis now as well as Aderans.

Aderans has been the biggest dissapointment in HM up till now. They came out with the biggest talk, the earliet projectons, only to get passed up by a little bio-company from England who has been much better about releasing information, updating their site, getting one trial finished and another started, releasing a picture, actually doing an interview with hairsite. Aderans has been a stone wall of silence occasionally interrupted by Washenik appearing in some media making a crazy prediction like 2009 when they havent even done a phase one trial for the FDA yet.

47

“London, United Kingdom, July, 2006 – Aderans Research, the specialist tissue engineering research group for hair loss, has announced plans for the commencement of London based clinical studies for the treatment of hair loss using its unique tissue engineering technique, a bio engineered hair loss solution that cultivates a persons own cells to overcome the problem of insufficient hair supply and pattern baldness”

“…has announced PLANS for the commencement of London based clincial STUDIES for the treatment of hairloss using its unique tissue engineering…”

What does "plans for STUDIES (not “trials”???) mean?

Have they really started the trial? Has anyone’s head been shot up with cells or no? I wonder. Ive never gotten a response from them when Ive emailed them.

48

Hey guys,

The whole thing is like an HM orgy when you analyze it… b/c Bosley, which of course is owned by Aderans, and Intercytex agreed in 2005 that Bosley would be given “exclusive” first negotiation rights for ICX-TRC. But Bosley will of course also be given exclusive negotiation rights for Washenik’s work through Aderans Research Inc. In essence Aderans, the japanese wig maker, has bought out the HM market.

Of course Washenik knows this… so could it be that he’s developing a “second generation” HM after Intercytex and Bosley releases ICX-TRC? Is that why he’s so quiet about Phase I?

As far as Bosley, I don’t think he’s limiting hair research at Aderans Research Inc. But it is odd when you realize Intercytex and Aderans Research Inc really aren’t competitors in the strict sense…

All the best,
BB

49

Here is the “trial news” from Aderans’ Phase I trial website:

"We are in the process of recruiting subjects into a Phase 1 clinical trial for hair restoration in London.

This clinical trial has received approval from the East London and The City Ethics Committee 1.

The trial is being conducted at 2 clinical locations in London. The London Bridge Hospital and The Cosmetic Surgery Center on Harley Street were selected based upon the expertise of the surgeons who practice there."

Also, check out a few of the earlier posts. People emailed Aderans and they said they had already begun Phase I trials. It appears the website has not been updated since 2006.

50

…hmmm…sounds like they are actually in phase one then. Good for them (and us, I hope).

Im ready to see something out of Washenik and his crew other than TV interviews and timelines and wildy optomistic timelines. Seeing that photo from ICX still has me psyched, and as this year passes, news from phase 2 inching closer also has me psyched.

51

So I took a few weeks out of my life this year and went underground to work at MHR and Bosley. I wanted to know how and why they were so popular and how they operated… a mole if you will.

Seeing how big Bosley is on the inside… seeing an efficiently streamlined operation… made me question why they would have interest in follicle multiplication. Why rock the boat of what appeared to me as a true “hair mill” money generating slaughter house. And to add MH-shade (MHR) to the mix, frightened me more.

So the bottom line is this… What I was exposed to Saturday at the webinar… was so damn interesting and I could not believe we were left with no future answers. It was an advanced webinar, which meant all participants were of the doctor status(an inside view)… so I could not understand the why things had not progressed past what you guys/gals have spoke about many times already.

BTW Boston Baldy… I was in Boston this year. My friend lives there. We went to BU and Harvard to look around. I like Boston.

52

I know, I agree 100%… but where’s the d*mn timeline from Aderans Research…? I guess they think they don’t need investors b/c Aderans (the japanese wig company) is pouring money into their research…

» …hmmm…sounds like they are actually in phase
» one then. Good for them (and us, I hope).
»
»
» Im ready to see something out of Washenik and his crew other than TV
» interviews and timelines and wildy optomistic timelines. Seeing that photo
» from ICX still has me psyched, and as this year passes, news from phase 2
» inching closer also has me psyched.

53

Hmmm… so do you think Washenik is just not revealing new info b/c the procedures are only meant for Bosley? Or do you think Bosley and Aderans (the wig maker) are just not supporting Washenik (though if you look at their annual report they increased funding for Washenik’s research)? Or maybe Washenik is just running into a bunch of problems… but then why experiment on humans for Phase I?

Okay, enough speculation… I’m off to bed… yes, Boston is good city, I love it… :wink:

» So I took a few weeks out of my life this year and went underground to work
» MHR and Bosley. I wanted to know how and why they were so popular and how
» they operated… a mole if you will.
»
» Seeing how big Bosley is on the inside… seeing an efficiently streamlined
» operation… made me question why they would have interest in follicle
» multiplication. Why rock the boat of what appeared to me as a true “hair
» mill” money generating slaughter house. And to add MH-shade (MHR) to the
» mix, frightened me more.
»
» So the bottom line is this… What I was exposed to Saturday at the
» webinar… was so damn interesting and I could not believe we were left
» with no future answers. It was an advanced webinar, which meant all
» participants were of the doctor status(an inside view)… so I could not
» understand the why things had not progressed past what you guys/gals have
» spoke about many times already.
»
» BTW Boston Baldy… I was in Boston this year. My friend lives their. We
» went to BU and Harvard to look around. I like Boston.

54

» …if they are implanting cells and they are formulating
» hairs, but the hairs are trying to shed at 21 days, before the cells are
» out of the dermis—thus causing an inflammatory reaction while you have a
» shed hair stuck under the dermis, and killing the newbie hair below
» it…

It is my understanding that the reason the hair cycles before it breaks the skin is because the mouse hair cycle is way shorter than in humans. So this might not be a problem with humans. However, some of the follicles created will probably grow in the wrong direction and not break the skin, so this will be a problem. IOW, it is a similar but different problem.

» …then this is why we had Washenik speculating a while back
» about growing the hairs “outside” the body and re-implanting. He wante
» them to be long enough to have the tips outside the dermis so when they
» shed they could fall out and not interfere with the dermal papilla as it
» rests, regroups, and starts a new anagen phase.

As far as I know, what you propose is not possible because current cultures do not have the right stuff to support follicles outside the body for more than a couple of weeks.

» I wonder if FUE docs, pulled hairs, but cut them off extremely short,
» below the skin surface right above the papilla (magically not damaging the
» arrector pilli muscle and root sheath etc—this is just a “suppose”),
» whether the regular transplant hair would phuck up if it couldnt reach the
» surface again by day 21 and the skin had grown over the hole in the dermis
» where the hair comes out (called the infidilum I think it was)? We’d
» probably have the same thing

Gho already did this with FM, and another researcher from italy also documented Gho’s technique for donor regrowth. It has been found that the amputated follicle will grow hair at the normal rate, thus the hair breaks the surface of the skin within a week and continues to grow normally (about 70% of the time). So the skin does not have time to close in this scenerio.

» ICX had no inflammation with their procedure though in phase one trials
» and grew hairs (some over 100 per cm). SO what are they doing different?
» Paul Kemp must be one smart dude…no wonder they
» dont want to divulge anything, this is a freakin’ race to history.

The reason they don’t have inflammation is because they simply inject the patient’s own dermal cells into the skin and allow them to interact with the host organism. This is very different from injection several types of cells that create new follicles on their own. IOW, dermal cells interact naturally with skin cells, so putting dermal cells in the body simply allows them to interact in a natural manner. But if you inject the skin cells with them, the skin cells wind up being too deep, and strange things can happen.

jb

55

» What baffles me is: why no data/info from Ken Washenik on Phase I, not
» even in terms of public relations? And why isn’t the press release on
» ARI’s website?

I have a feeling the research Washenik demonstrated is not the technique they are using in phase I. From what I can tell, they have studied numerous approaches.

56

That’s possible, but wouldn’t they then be lying on their website? Here’s an excerpt from their clinical trials FAQ:

  1. Describe the process from start to finish.

A 1cm x 2cm skin sample is taken on the back of the head under local anaesthetic. The skin sample is then placed in a sterile container and sent to the UK cellular laboratory. Here the fibroblasts and keratinocytes (the hair producing cells) are grown to a large quantity using the proprietary cell expansion process. After a five to six week period, the trial subject receives the first therapeutic injection of their newly grown cells.

  1. What is the cellular treatment?

    This process is an autologous cell therapy that uses the patient’s own fibroblasts and keratinocytes in sufficient quantity to elicit hair growth. It is the first and only natural process to use the patient’s own twin cell lines to stimulate new growth.

» » What baffles me is: why no data/info from Ken Washenik on Phase I, not
» » even in terms of public relations? And why isn’t the press release on
» » ARI’s website?
»
» I have a feeling the research Washenik demonstrated is not the technique
» they are using in phase I. From what I can tell, they have studied
» numerous approaches.

57

» Is it reasonable to say that given the fact that Bosley has a billion
» clinics, bought MHR which expands their clinics to a trillion… that it
» might be possible that they would not like this research to go through?
»

I think quite the opposite. If they can perfect a technique, they will make multitudes more money by offering it in their clinics than they will by offering HT. Maybe the reason thy bought MHR is because they are attempting to get the necessary infrastructure in place prior to rolling out HM. They do not need to get HM perfect. They simply need to offer it as an adjunct to HT that will increase the amount of usable donor hair. If they can do that, the demand will be off the charts. And with the number of clinics they have, their profit will be in the gazzilions.

I think Aderans has taken their time and explored numerous different directions in an attempt to figure out the best way to procede forward. My feeling is that they will offer a “one cell” approach which is a really a mixture of cells, but the main cell type will be dermal cells housed in an injectable matrix. This 3-D structure allows the cells to clump, and this has been shown to keep the cells viable through many more passages than they otherwise can remain viable.

This is a quite different technique than ICX is using. Since Aderans has first option to ICX’ technology, they really have nothing to lose by researching other directions. If ICX is successful, they can license the technique in their clinics. If ICX fails or is only moderately successful, Aderans has already spent many years researching the next big step in HM technology. So IMO, they are being extremely smart here and hedging their bets for the future. The reason I believe they don’t reveal much information about their clinical protocol is because they prefer to not have a lot of competition with their proprietary techniques.

58

This seems reasonable 007.

59

» That’s possible, but wouldn’t they then be lying on their website? Here’s
» an excerpt from their clinical trials FAQ:
»
» 1. Describe the process from start to finish.
»
» A 1cm x 2cm skin sample is taken on the back of the head under local
» anaesthetic. The skin sample is then placed in a sterile container and
» sent to the UK cellular laboratory. Here the fibroblasts and
» keratinocytes (the hair producing cells) are grown to a large quantity
» using the proprietary cell expansion process. After a five to six week
» period, the trial subject receives the first therapeutic injection of
» their newly grown cells.
»
»
» 2. What is the cellular treatment?
»
» This process is an autologous cell therapy that uses the patient’s own
» fibroblasts and keratinocytes in sufficient quantity to elicit hair
» growth. It is the first and only natural process to use the patient’s own
» twin cell lines to stimulate new growth.
»

No. That is exactly the technique I believe they are performing their human trial with. But it is important to note that the website description is extremely abstract. If you look at their early work in this area and their patents, you will see that they have broken a ton of ground using injectable matrices. So they do exactly what you described, but they actually grow the cells in a 3-d matrix, which allows the cells to clump. Jahoda showed that when DP cells clump in this manner, they do not break down in culture like cells cultured in a 2-d manner.

ICX and Gho use a 2-dimensional culturing technique. OTOH, ARI has one of the world’s formost experts on hand in 3-d culturing techniques. In fact, prior to being aquired by ARI, he was the first person ever to grow hair on a human using DP cells cultured in a 3-d structure.

What I believe is happening is that ARI is not mimicking ICX’ work. They have no need to do this because they have first rights to it. So their scientists are working on stage II HM, if you will.

Please not that the quote you used above says “fibroblasts and keratinocytes.” This is very different than twin cell injections using epithelial and mesenchymal cells. So either I am misinterpreting the presentation given, or they are using a different technique than presented.

edit: The reason I have been saying that the research they presented used epithelial and mesencymal cells is because the hairs died before breaking the skin (I haven’t seen this in previous mouse research using dermal cells and keratinocytes), but I have seen dermal and epithelial mouse experiments where some hairs don’t break the skin and inflammation results). But it is entirely possible that I just jumped to conclusions and the hair didn’t break the skin in a normal epithelial reaction using dermal injections. I’d have to see the ppt to know for sure. From my reading, two cell approach means epithelial and mesenchymal. But it appears ARI is using the term to simply mean dermal fibroblasts and keratinocytes. But that seems really lame to me, because this is the exact same approach Jahoda outlined in his patent back in the 80’s.

I should say though that their website is a lie for a different reason than you have stated, because both Gho and ICX have used fibroblasts and keratinocytes to grow hair on humans. And long before they did this, Jahoda patented the technique.

60

I should add that ARI has performed research inserting a thin wire into each injection site that allows the hair to follow it up through the surface of the skin. IMO, it would be possible to put both dermal and epithelial cells into the matrix and use the wire to orient the resulting follicle. I believe this is one of the techniques they are working on, but I haven’t seen it mentioned exactly like that.

Washenik likes to give interviews. Perhaps David can talk him into a brief interview and we can gain more information about the technique they are testing in phase I. It would be interesting to find out what they are working on, find out why the FDA shitecanned their US studies, and also get a new timeline for rollout. :slight_smile:

Also, I haven’t contacted Stenn in quite a while, so if I get some free time, I might do that.