Replicel Interview w/ Dr. Rolf Hoffmann & Lee Buckler

hellouser

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Finally done! Enjoy guys. Lot's of great insight in this interview as well as all questions were answered that you guys submitted. More to come later!

Also, I had another quick chat with Dr. Hoffmann and he mentioned that the Replicel technology will be licensed, so pricing may vary from clinic to clinic, therefor Replicel cannot dictate what the costs will be. Furthermore, it should be inline or less than a typical hair transplant (by that, I'm talking Bosley prices, NOT Dr. Rahal prices).
 
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macbeth81

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Very nicely done. We have been talking about RepliCel for years and you actually go to meet and talk to them directly in-person. That had to be an experience.

Below are some notes I gathered from listening.

  • The Japanese trial phase was listed TBD in their presentations because of the nature of Japanese regulation differences (3:50).
  • They clarified that IPS cell usage was a misunderstanding (4:40, 32:25). Shiseido are going to use DSC cells; same as RepliCel.
  • Converted hair follicles with DSC cells will be potentially permanent, but not all follicles may be converted with one injection. This is still a hypothesis though (6:55).
  • Shiseido may only be trialing a single dosage (8:30).
  • Cannot store cells for follow-up and would require a new sample, but potentially can be done off-label (9:15).
  • Cells do not lose inductive properties over time. They have stored cells for a year and technically can last years (11:25).
  • Next Phase trials in Japan and should start within the next couple of months (12:20). RepliCel will be starting their trial in Germany in 2016 (13:00).
  • The Phase II delay was caused by GE :mad: (14:30). The issue was because of discontinuation of culture medium. It takes 12 weeks per experiment to culture/verify data (15:40), hence the long delays.
  • There is no ruling whether the German regulators will accept the new culturing method, therefore, there is risk that they will have to restart their trials (17:20).
  • There may be synergy effect using RepliCel with Histogen, but probably not necessary (21:30). Trialing them together would be difficult (23:00). This would be a Phase 4 trial (post market).
  • Shiseido will start trials first (24:25).
  • RepliCel will try to find minimum dosage used to regrow hair (25:40).
  • They will not try wounding, since act of injecting is effectively a wound itself (27:00). They are not believers in wounding it appears (27:20). Hellouser doesn't sound to be much of a fan either :)unsure: 29:30).
  • SwissTemples is an example that even with miniaturization there are still hair cells and thus should be responsive to treatment (31:50).
  • Shiseido is working with Harvard on other techniques, but for this product the development is collaborative between RepliCel and Shiseido (32:25).

I figured the IPS cell usage was a misunderstanding. This came from one article that referenced a Yahoo article which did not state such. Since then people have been spreading this misinformation.

I am surprised Dr. Hoffman sounded dismissive of wounding considering campfire man and other incidents. But as they said, a lot of people are not as dedicated as our forum members.

Getting a full thickness burn (painful) to regrow hair wouldn't be as commercially successful. I would liken it to Lasik vs PRK. Even though some of the short-comings of PRK (e.g. coronal haze) have been mitigated, more people still opt for Lasik for the painless & instant results despite it compromising more tissue (to create the "flap").
 

Solomon

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I don't know if it was positive or not :\ What do you think guys? Did you like what they said? I mean I wanted to hear that they had cure :D

btw Thanks Hell for everything. You are the maan! :d
 

whatevr

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Sounds promising, but until we see it first hand, we know nothing.

Either way, sit and wait, same as before.
 

Dragonborn

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I don't know if it was positive or not :\ What do you think guys? Did you like what they said? I mean I wanted to hear that they had cure :D

btw Thanks Hell for everything. You are the maan! :d
So listened to this interview which was great and hellouser did a great job.
What I gleaned from it:
You will notice that Mr. Buckler used the term "full head of hair" with quotes. at this point they will have extensive Phase 2 trials with different dosages, different number of injections and later on biopsies. After that they will assess the efficacy of RCH-01.
Now I assume their Phase 2 trials last almost 3 years because they want to see if it works at immunization of hair follicles from androgen sensitivity. Contrary to Phase 2 of SM-04554 which lasted a year because they needed effectivity data after 3 month mark.

So yes I agree with previous posters what we need in the end is their Phase 2 trial results. Even if their RCH-01 serves as a vaccine only it still has a lot of potential.
However it is mildly unpleasant that we have to wait for 2019. for them to finish their Phase 2 trials. I mean sure Shiseido might be done sooner but I believe that the Phase 2 trials in Germany might tell us better how good/effective RCH-01 is.
 

what

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We definitely won't see Replicel in North America before 2020, probably not before 2025. Hell, we still don't even know if it will work at all. What's crazy is that they received the go-ahead for phase I back in 2010. We're now coming up on 2016 and they've yet to run a phase II trial. 4-5 years of nothing and we're supposed to buy that it's due to the growth media problem? Come on man. Replicel has no interest in bringing this to market themselves - they're hoping and praying for more licensing or a full on sale of the IP, which is why they've delayed proceeding with trials. They desperately want someone to step in and pick up the trial costs and the risk (of no efficacy) for them. This is just my opinion, of course. Thanks to Hellouser for the hard work.
 

EvilLocks

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Nice hellouser! I'll listen to the full interview when I have time tonight. I listened a couple minutes in right now, and I have to say you sound handsome judging from your voice! Anyway great job. I cannot thank you enough for doing this.
 

Seuxin

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Hello guys,

Thanks for the good job first :)

* I have difficulties to understand difference between Replicel and Sisheido...At final...they will provide the same cure ? Or they will provide two different product ?
* Why are they able to immunize follicles to DHT ?
* Any regrowth are provided by this technology ?
* Any idea of a release date in Europe/US ?

--Sorry for my frenglish :)

Thanks a lot guys :)
 

DDobler

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Hello guys,

Thanks for the good job first :)

* I have difficulties to understand difference between Replicel and Sisheido...At final...they will provide the same cure ? Or they will provide two different product ?
* Why are they able to immunize follicles to DHT ?
* Any regrowth are provided by this technology ?
* Any idea of a release date in Europe/US ?

--Sorry for my frenglish :)

Thanks a lot guys :)

As far as I understand, Replicel's technology is in the special cells they take from your back of the head. These cells of the dermal sheath (the cover of the hair fiber) and are supposed to maintain the dermal papilla and make it grow or be "healthier" and by that, they want to make the dermal papilla in the balding areas as similar to that in the back of the head, where obviously the hair grow better there. So maybe the hair fiber in the balding areas will grow too and the hair in it will grow better and thicker.

I am not sure tho :]

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I would like to know if they have some new results\photos, and what growth ratio we are talking about. about how much percentage, and if it should be maintained for long time or we will need to come back every now and then to have more injections in the same area.
 

Baldie_86

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Hello guys,

Thanks for the good job first :)

1) I have difficulties to understand difference between Replicel and Sisheido...At final...they will provide the same cure ? Or they will provide two different product ?
2) Why are they able to immunize follicles to DHT ?
3) Any regrowth are provided by this technology ?
4) Any idea of a release date in Europe/US ?

--Sorry for my frenglish :)

Thanks a lot guys :)

1) They will provide the same product, the only difference is that Shiseido will probably run a trial with a single injection while Replicel's trial will have two or three injection
2) We don't know yet, they hope so
3) We don't know yet, they hope so
4) If everything will go smooth, i think 2021/2022, but we should now if it works earlier.

Speaking of the results of the trials, do you think they will provide something during phase 2 or we have to wait the end (2018)?
 

HairlossCurse

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Regarding the wounding work done by cotsaerlis, I believe that it is all about timing and depth of the wound. Also, it is for creating new follicles, not regrowth, so I believe it is for treat scarring alopecias where follicles are lost, male pattern baldness is non scarring. All of cotsaerlis work is now directed at this technique, I think he believes pgd2 will to the job for male pattern baldness.
 

moarhairpls

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An overall positive interview. They are confident that Sheisido's next trial will begin shortly. If that's the case then we should indeed be able to fly to Japan in 2018 for treatment if that trial goes as anticipated. They seem quite confident that they will be able to grow a reasonably full head of hair too. The only problem is that multiple injections will probably be required over a period of many months, so multiple expensive trips to Japan will be required depending on your current state of hairloss. I wish hellouser had asked what they anticipate the pricing structure will look like. It was a good interview though. Thanks for doing this hellouser.

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Fingers crossed that the board that they are submitting to in Germany approves the trial two phase, because they could ask them to go back to the phase 1 trial since the medium now is slightly different.

And of course that the Sheisido's trials in Japan go smoothly and successfully. If it doesn't who knows how much more we'll have to wait.

They took care to minimize changes, so I think it's unlikely they won't be cleared to start the next trial. For me the German trial is irrelevant though. Shiseido will be done first, and I plan on being on the first flight to Japan once it's available.
 

Folliman

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Great job, hellouser! I hope this works and I hope the trials actually start soon. I would love to see pictures of the treatment being successful only to have the peace of mind that the cure is actually 5 years away just waiting to be approved.
 

Saint-Loup

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I don't understand why this company is posting on Twitter almost everyday if they are still in phase I???:dunno: What's their goal??
https://twitter.com/replicel

Regarding the wounding work done by cotsaerlis, I believe that it is all about timing and depth of the wound. Also, it is for creating new follicles, not regrowth, so I believe it is for treat scarring alopecias where follicles are lost, male pattern baldness is non scarring. All of cotsaerlis work is now directed at this technique, I think he believes pgd2 will to the job for male pattern baldness.
Look at the pictures of this study (june 2015) all these men were using finasteride+minoxidil for several years...
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4458936/
 

hiitsjam

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An overall positive interview. They are confident that Sheisido's next trial will begin shortly. If that's the case then we should indeed be able to fly to Japan in 2018 for treatment if that trial goes as anticipated. They seem quite confident that they will be able to grow a reasonably full head of hair too. The only problem is that multiple injections will probably be required over a period of many months, so multiple expensive trips to Japan will be required depending on your current state of hairloss. I wish hellouser had asked what they anticipate the pricing structure will look like. It was a good interview though. Thanks for doing this hellouser.

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They took care to minimize changes, so I think it's unlikely they won't be cleared to start the next trial. For me the German trial is irrelevant though. Shiseido will be done first, and I plan on being on the first flight to Japan once it's available.


Here is another replicel interview posted on BTT forum https://www.*********talk.com/threads/22131-Replicel-Sets-The-Record-Straight

As far as pricing structure goes, it will cost as much as a hair transplant (from a respected doctor) costs as of today. This is clarified by VP of Business and Corporate Development for Replicel in his interview posted on BTT.
 

moarhairpls

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Here is another replicel interview posted on BTT forum https://www.*********talk.com/threads/22131-Replicel-Sets-The-Record-Straight

As far as pricing structure goes, it will cost as much as a hair transplant (from a respected doctor) costs as of today. This is clarified by VP of Business and Corporate Development for Replicel in his interview posted on BTT.

That is Spencer's assumption, to which the VP wouldn't even agree. After some arm twisting and Spencer putting words job his mouth he agreed it's an unreasonable assumption to make, but they don't know yet. I wouldn't put much stock in that. It could end up being considerably more or less.
 

hellouser

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Actually, there was an interview with David Hall a while back, I don't have the link, BUT, it looked like a TV news station with a desk and anchor. I do recall the question about costs being mentioned, and there was mention of it being competitively priced with hair transplants.

I actually had another brief discussion with Dr. Rolf Hoffmann and costs was something I asked about as well, and again, it would likely be around the price of a hair transplant. But we know hair transplants can vary in price from a few thousand to nearly $20,000 if going with someone like Dr. Rahal, but it's pretty safe to assume it'll likely be closer to the $6k - $9k range. HOWEVER, since Replicel itself won't be administering the procedure, they're not the ones that will be setting the price as the price will be determined by clinics, so it's still a bit early to tell what the price will really be. Let's just hope there are enough clinics that will adopt Replicel's technology with a race to the bottom that will benefit a wider consumer base; keeping the costs high will make it exclusive to the very rich.

There's also been some speculation that a similar treatment costs about $3,000-$5,000 but I don't remember what it was.

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Nice hellouser! I'll listen to the full interview when I have time tonight. I listened a couple minutes in right now, and I have to say you sound handsome judging from your voice! Anyway great job. I cannot thank you enough for doing this.

:blush:
 

Ruh

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Hi hellouser, this is my first post in hairlosstalk & I'm following this site specially your threads on 9th congress since last month. However I'm Norwood class vii and I want to know how much effective replicell can be for Norwood vii ? Is there any potential that I can back my all hair as replicel claimed full head of hairs ? Your expert opinions on this will be much appreciable. Thanks.
 
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