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Q&A with Dr. Paul Kemp, Co-founder and CEO of HairClone


#21

Has HairClone determined which cells they plan to use yet? If they haven’t then we wouldn’t know which cells to bank yet either.

And then there’s the issue of transporting the cells to HairClone in UK without risking damage to the cells. I’m on the USA west coast. The USA west coast to UK is a long way to travel with numerous stops, changes of altitude, and weather.

I think the technology for a breakthrough cell-based treatment for hair loss will probably be reported this year, but it will be a few more years of clinical trials before it comes to market by standard approval. If I’m going to have to wait those few years of clinical trials even if I’m on board with HairClone that’s not beneficial. From what I’ve read it looks like HairClone is saying there might be a way around waiting for clinical trials to complete. I understand you can’t give specifics but can you inform me if I’m misunderstanding what HairClone is saying about that?


#22

Roger, does this sound like some kind of early access to you? It does to me but I can’t really confirm that. I actually understand PaulK’s unwillingness to reveal these kinds of details but I’m sure that as someone else who also wants treatment asap you understand why it would be important to me whether or not investing in HairClone would mean getting to skip the remaining clinical trials after the tech is invented and reported to grow a satisfactory amount of quality hair via cell-based treatment. I’m missing over half of my hair so I would want at least 50% more hair so I’m talking about a major cell-based hair growth breakthrough. I know I’m jumping the gun but I do believe that the technology to achieve this will probably be invented this year. The stuff researchers are reporting suggests that they’re close.


#23

Well, I could possibly read a few things into what Dr Kemp has said. First thing is that if they’re talking about banking people’s cells for 20 years, that could indicate that they’re not exactly confident they’ll have a fully-working protocol (what I would call a “cure”) in the next 20 years. So the strategy of banking cells is to give people a chance to put their cells in “stasis” (so the telomeres don’t shrink and the cells don’t age) until a cure is available, which may take up to 20 years. That’s only one way of looking at this.

The other way of viewing it is that they’re reasonably confident that a cell-based cure is coming in the next few years (as you predict), and the cell banking is more of a way of earning some current revenue to keep the company going in its research phase (because until they have a viable protocol, they won’t be earning a lot of money from patients otherwise). Which to me, is a quite reasonable thing to do. There is certainly no harm to the patient in cell banking, and in fact there can only be two outcomes: a long-term benefit of having youthful cells to work with (if a cure takes a long time to come), or a “wash” (a relatively small expenditure for patients made up for by a cure coming much sooner.)

The latter scenario (a company raising money from prospective customers to fund a product which will materialize in the future), in fact, is akin to crowdfunding. Which raises the idea that HairClone could be a great candidate for a crowdfunding campaign. Now that they’ve freed themselves of the clinical trials straightjacket, it’s possible that some crowdunding sites might accept a campaign like this. There are even a few sites that specialize in crowdfunding medical research.


#24

I like the idea of crowdfunding, we have seen other companies failed miserably in the past, time to do something different so that research will not be cut short because of money.

Paul said it cost $2500 for 20 years of storage. Assuming they can find 5000 patients, that is $12.5M they can raise.

Do you guys have an estimate how many years of research can HairClone get from a $12.5M investment?


#25

I will try and answer all the questions since I was last on here. Our intention is to cryopreserve and bank all the various cell types. We are also confident based on preliminary data that we will be able to ship cells from around the world to the UK.
As to the 20 year storage comment, that comes from responding to the question about cord blood banks but one of the limits of current hair transplantation is the difficulty of treating young patients who are just noticing hair thinning. I don’t think anyone expects hair cloning to “cure” androgenic alopecia so these patients would need occasional pretreatment as their hair loss progresses.


#26

It’s a delicate decision to make. We have to take into account that when HairClone is able to offer treatment, the final price will be £2500+ procedure price.
Imagine, if Replicel or Shiseido start offering treatment next year, you will approach them with less money and less donor hair to offer.
To me it’s a bit like buying bitcoin shares. Investing in one of those start-ups that has vision and ambitions but no clear product yet.
My stand here is; I want to hear more details about their own protocol or any potential arrangements with party concerned (replicel, shiseido or similar) before I commit myself placing the bets.
To me it’s a bit like buying a cat in the bag at the moment.


#27

Well, the way I see it, HairClone’s hair banking offer isn’t exclusively tied to using the banked cells for their own procedure. It’s a free-standing offer to cryopreserve and bank your follicular cells. If Replicel or some other company or practitioner should come up with an viable procedure first, I’m sure that you could withdraw cells from the hair bank, just like withdrawing money from your bank account, and give them to Replicel or whomever. At least, that’s the way I understand it. Is this correct, Dr Kemp?


#28

$2500 for 20 yrs storage is reasonable but if there Replicel or others are available in the next 2-3 years then I do not have the need to bank my follicle cells. It is more suitable for those who are already norwood 5 or 6 and need this service to buy some time.

Very good news even though I have no use for it now.


#29

I need some clarification here. The word crowdfund has been used several times but my understanding is that this is really about HairClone selling a banking service, we are not crowdfunding as investors in HairClone, are we?


#30

@Myles - perhaps you should read the posts on here more carefully. I wrote that the cell banking idea was AKIN to crowdfunding (and I explained why). I did not write that it IS crowdfunding.


#31

Dear Dr Kemp.

I suggest there is a significant barrier involved in any attempt to grow large hair follicles in the MPB scalp, using any kind of implanted cell based treatment. According to the claims of mainstream physiology, current hair follicle research fails to take account of a basic in-vivo growth control, that must be involved in hair follicle enlargement.

This is the fundamental spatial growth control that governs all normal tissue growth in-vivo described here. http://phys.org/news/2014-04-room-tissue-growth-cell-response.html Only cancerous tissue growth can avoid this external pressure based growth control, so this must also apply to hair follicle enlargement in-vivo.

There is a wealth of evidence that spatial controls are the primary in-vivo cause of follicle miniaturisation in MPB, and any cell based treatment will meet the same fate in the conditions of the bald scalp. The transplantation of whole large follicles is a different issue. My article on the subject can be read here.
https://www.academia.edu/17570665/A_Review_of_the_issues_in_Historic_and_Current_Hair_Research_and_an_Overlooked_Connection.

Whilst there is some evidence in general physiology, that the initial wounding of an implantation process can relax this control slightly, any follicle growth would be brief and not produce significant hair growth. I would welcome your comments.


#32

Dr. Kemp,
I understand at this early stage it might be tough to forecast what may happen in the future but can you give us an insight as to what HairClone’s ultimate goal is and perhaps when you can possibly see a HairClone treatment coming to the market. Also will HairClone only be pursuing approval in the U.K. or will other markets such as the US be explored and do you think you will be able to utilize the newly passed 21st Century Cures Act for an expedited release?


#33

Dr. Kemp I’m wondering if you’ve seen this study about mass pass culture of DP cells?

https://minerva-access.unimelb.edu.au/handle/11343/55427

Does this study give you a way to mass pass culture DP cells while preserving hair inductivity? If it does then why not just use this method because it appears to be ready to go already. No more research appears to be needed.

I think HairClone might even be able to use this method for free since it appears to be public-funded research.


#34

That is absolutely correct. Patients would be free to withdraw their cells for others to use. Whatever the final process that is developed, follicles would have to be taken, expanded and returned to the patient as this three step process. By banking patients have already undertaken step 1. Plus, as I mentioned earlier, we would use this banking revenue to help develop our own expansion process and we would recognise the banking patient’s help by significantly discounting this expansion cost


#35

Lucky. The eventual intent would be that a patient banks their cells when they first notice hair loss. These cells could be expanded and implanted at intervals as needed to regenerate or replace the hairs from various regions as they miniaturised and by this process, you could imagine that people would never appear to be losing hair. Obviously it is a different situation for those with already noticeable hair loss.


#36

jarjarbinx. thank you, yes, we are aware of this work. There is nothing to stop researcher’s patenting publicly funded research. In fact that’s what Universities do all the time.


#37

Orlida. several questions here. HairClone’s ultimate goal would be to develop a process whereby a patient, when they first seek treatment, would go to a clinic where (1) a small number of follicles would be removed by FUW process and shipped to a HairClone bank where (2) the cells would be isolated expanded and cryopreserved. At intervals as the patient’s natural process of hair loss continued, portions of these cells (3) would be shipped to a clinic where they would be implanted back in the patient. As I have mentioned, this is a three step process and we aim to be in a position to provide step one this year. Step (2) is, as everyone realises, the one that needs to be developed and we would use revenues from (1) to help fund the research for this. We aren’t able to set a timeline at the moment as to when step (2) would be optimised and in part it depends on how much research funding was available, in part from patients who had taken up step (1)


#38

Orlida. Although we intend to start this process in the UK, we would be seeking to gainmarketing licenses outside of the UK


#39

Footy. I read your interesting article. There is much we still don’t understand about the human body and this is one reason many Developmental Biologists have used the hair follicle as a relatively simple model system. Even with this, there is an enormous, and growing, amount of basic and applied peer reviewed literature in this area some of which appear to be contradictory which can cause confusion. This is part of the reason we developed our strategy of developing a treatment process in a stepwise fashion in collaboration with clinicians, rather than trying to adapt findings obtained in animals into the human condition.


#40

Dear Dr Kemp.

Thank you for your response.

I agree there are complications and contradictions in the data about hair follicle miniaturisation, and the associated local tissue changes. Thats why we have to look for a possible common factor, that could make sense of the data. I suggest once you apply the principle of pressure based spatial growth controls to hair follicles, a common factor in the data becomes clear.

I argue in my article that the changes of the hair cycle and the follicle structure, are perfectly adapted to be manipulated by even small pressure changes in the dermal tissue. This has important purpose in evolution. The common factor in most types of hair loss, is an increase in the dermal pressure for whatever reason. Hormonal actions, immune responses, toxic effects, radiation effects, and chemotheropy.

IN MPB we are all aware of the increased tightness of the scalp. In MPB there are associated immune changes, hypoxia, fibrosis, increased mast cell activation (PGD2), and significant sweating changes. All of these factors are recognised in tissues subject to increased fluid pressures, like lymphedema.

This in-vivo growth control also makes sense of the contradictions in the in-vitro and organ culture studies, that do not translate into effective MPB treatments. These studies cannot replicate the pressure conditions in the Human MPB scalp, and so are misleading.

This is an issue that any cell based treatment intended to regrow large follicles in the MPB scalp, will just not get around without creating dangerous tissue growth. In my opinion the only way forward is to deal with the external pressure conditions more effectively.