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


#1

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

Dr. Paul Kemp, Co-founder and CEO of HairClone, has agreed to answer questions in our community about his latest endeavor in the pursuit of an effective hair multiplication protocol.

Feel free to raise your questions here in this thread.

Thank you
HairSite


#2

I am happy to go first.

Why are we banking cells when we don’t even have a real hair multiplication treatment available ?


#3

I am sorry if I am not current with all this but what exactly is Hairclone selling?


#4

How much does the hair follicle banking service cost?


#5

Hi Helpmeout, EAS83 and Lucky,
To answer your questions, I have to give some background into the formation of HairClone so bear with me.

The classic approach to developing a new medicinal product or treatment and the one we used at Intercytex and others are using currently is one which I call “scientific innovation”. The basic process of being to
a) Design a hypothetical product/treatment based on the best scientific and pre-clinical information available
b) Raise large amounts of investment either through Venture Capital or from a commercial partner
c) Design a series of clinical trials to test the hypothesis from a) and hope the outcome is sufficient to maintain the interest from the funders to continue the work
d) If all goes well eventually produce after many years a commercial product that then can enter the market and provide a sufficient return on the investment to satisfy those who have invested their risk capital

Importantly, often in order to spread the financial risk, investors will demand a “product pipeline” of other medical products so that if the lead one fails or falters there is a back-up.

I have come to realise that scientific innovation is not best suited to the development of medical products that are surgically applied. Here, success requires the right product to be implanted in the patient in the right way and I have found that you are working with two many unknown variables to get it right the first time. Was the lack of absolute success due to the product or the way it was implanted? Unfortunately, investors rarely have the stamina for a second attempt and they prefer that the company moves on to their back up projects so that they have a chance of a return on their investment within the time horizon of their VC fund which is exactly what happened with Intercytex. It is VERY important however to emphasis that clinical trials are absolutely needed to eventually gain the licenses needed to MARKET a product in a broad international market and we absolutely intend to carry these out but not until we have optimised the treatment itself.

There is another way to develop a medical treatment however and I call this “Medical Innovation”. Its what hair transplant surgeons do all the time. They innovate step by step, learning from their peers, sharing best practice etc and this has resulted in the transition from punch grafts to FUT then FUE and the innovations will continue. I have seen the power of this approach many times and I have been working with regulators to discuss how this could be applied to the use of cells as medical products (Known as either Regenerative Medicine, Cell Therapy or Advanced Therapies).

An international group of us with a huge amount of experience therefore came together about a year ago to combine all these scientific, clinical and financial learnings and we had a series of meetings to develop the business plan of HairClone which at its very simplest is to:

a) Create an exclusive group of Clinicians, patients, scientists and biotechnologists, who will combine the best elements of scientific and medical innovation to bring hair cloning into clinical practice
b) Importantly fund the development of this treatment, not through classic investor routes, but from the interested parties themselves. The intention is that through such a partnership we can better develop the treatment step by step rather than the one-step/one-shot approach that is inherent with scientific innovation where external VC funders control or stop the development process if the perfect solution isn’t developed at the first attempt.

We chose the name ‘HairClone” to emphasis to everyone, both the nature of our mission, but also perhaps more importantly, that we have one mission and one only and that we weren’t going to generate a portfolio of products and thereby dilute our efforts.

As you can see from our website, we already have some of the leading hair transplant surgeons as our clinical partners and we will be inviting others to join later in the year. We also have Claire Higgins and Paul Sharpe on our SAB. Both of these highly respected developmental biologists are interested in cell induced organ regeneration and are providing really important input. We have already started clinical implantation work to better understand what we will need to do in the future and we are also developing international research collaborations so that all the various elements that I described above can be combined. Our next step is to begin to involve an exclusive group of interested patients and we are going to do that through crowd-funding which is currently being set up and follicle banking.

As you point out, why bank cells now when a patient could just bank hairs when we are ready to treat. There are several reasons why and I would really like to get your feedback on them. Firstly, all the revenues we raise through banking will be used to develop and thus accelerate the time to the treatment itself. Secondly the banking patients would then be first-in-line for treatment when it is available. Thirdly it has been shown that even DHT insensitive hair follicles age and finally we want to recognise the banking patients’ very important contribution to the development of the treatment by providing a significant discount to the treatment that would more than compensate for the cost of the banking.

I am sure that banking now would not be attractive to all people, but all of us involved with HairClone are convinced that the best way to achieve this in the shortest time frame possible and with the greatest chance of success is through an exclusive partnership and deep collaboration. Follicle banking is just one element of this.

We are currently obtaining the regulatory licenses required to set up a cell bank and we expect the cost to be similar to the costs of other banks such as cord blood. The difference between what we are doing and what Cord Blood banks do which is just bank cells as an end in itself is that we will be using the revenues to develop a treatment.

I hope this helps, but I am very happy to discuss more and welcome your feedback


#6

So HairClone is analyzing all of the currently hair cloning information available to try to determine the best possible treatment, right?

Will HairClone include brand new emerging information when it’s disclosed throughout this year, such as information that’s disclosed at the upcoming Hair Loss Congress in October?

If Replicel releases information demonstrating breakthrough success with their method at the Hair Loss Congress or sooner is it possible that HairClone might try to partner with Replicel so HairClone could start offering this technique late this year or early next year?

If new information is released this year at the Hair Loss Congress that gives a blueprint for how to achieve mass pass culture of DP cells while retaining inductivity/trichogenicity would HairClone try to partner with the researchers who achieved that so HairClone could start offering this technique late this year or early next year?

It’s my understanding that HairClone is trying to use the best possible hair cloning technology on earth and they want to start offering that technology to customers later this year or early next year. If that is the intention then is HairClone paying attention for new developments/information from hair cell researchers that will be reported throughout the year, especially at the Hair Loss Congress?

Some other issues I would like to raise:

If a breakthrough is reported someplace such as the Hair Loss Congress will HairClone talk with the researchers involved to try to work out n agreement to use that technology now on paying customers by the end of the year or early next year, while the researchers who own that technology continue taking it through clinical trials? If not, then I see no point to your effort or your HairClone’s existence.

For example, if you’re not going to try to work out a deal with researchers who discover how to mass pass culture DP cells while preserving inductivity/trichogenicity then anything you try to do with mass pass DP cell culture will likely fail due to inductivity problems. So your efforts would be useless. We would be wasting hair follicles from our donor area if we got a DP hair cell cloning procedure that didn’t have a solution to the hair inductivity/trichogenicity problem with mass pass culture.

And if you aren’t going to use that technology NOW instead of waiting until it comes to market via standard clinical trials then we really wouldn’t need HairClone because if we have to wait until the technology completes standard clinical trials we can just get it from the researchers who take it through clinical trials at that point in time. We wouldn’t need HairClone to get it after it completes standard trials.

If Replicel reports breakthrough success and you don’t try to work out a deal with them to use their tech on paying customers NOW while Replicel continues trials then why would we need HairClone? If we’re going to have to wait until the tech completed clinical trials then why should we invest $ in your company when we can just get it from Replicel?


#7

Is HairClone based in the UK? Do we have to travel to the UK for follicle banking?


#8

HairSite: thank you for inviting P.Kemp to this forum.
Paul: it’s a pleasure to have you here.
I have no medical background and all my understanding about DP,DSCC, IPSC cells, cells inductivity, loss of trichogenetic properties and so on came from research online. So my definitions might not be exactly correct. Nevertheless.
As you and K.Washenik were probably pioneers in trying to bring benefit of hair cloning to commercial application, surely you must have come across the issue of cells ( in your case DP cells) inductivity.

  1. Whichever cells you’re working with, have you solved this issue?
    if so,
  2. Does it require use of IPSC cells in order to achieve this? Do you use IPSC cells in your new approach at all?
  3. I understand Hair transplant is autologous cell transplantation. So it does not require special approval. Your method, as you said, is cell therapy. Therefore it will require set of trials for approval? Would British law allow you to offer cell therapy without approval? I understand we could qualify as trialists rather than consumers. Would that change anything?

#9

A lot of questions have been raised so I will try to answer them here. The easiest one to answer first is TKS

HairClone is based in the UK but our Clinical partners are in the US, UK and Australia (see website). We plan to start the bank here in the UK but also to allow our partners to ship follicles to us from around the world so you wouldn’t have to travel to the UK. In order to do this we will first need a license from the UK’s HTA and then an additional license from the HTA to allow importation once we have determined the optimum shipping system which is already under development.

Then as to the other questions

Q So HairClone is analyzing all of the currently hair cloning information available to try to determine the best possible treatment, right?
A. Partly true but we are also developing our own

QWill HairClone include brand new emerging information when it’s disclosed throughout this year, such as information that’s disclosed at the upcoming Hair Loss Congress in October?
A We intend to keep everyone informed of our progress through various meetings, social networks etc

Q If Replicel releases information demonstrating breakthrough success with their method at the Hair Loss Congress or sooner is it possible that HairClone might try to partner with Replicel so HairClone could start offering this technique late this year or early next year?
A Well that is really a question for Replicel but from our side that could well be possible

QIf new information is released this year at the Hair Loss Congress that gives a blueprint for how to achieve mass pass culture of DP cells while retaining inductivity/trichogenicity would HairClone try to partner with the researchers who achieved that so HairClone could start offering this technique late this year or early next year?
A Same answer as above. We do want to complement rather than compete

QIt’s my understanding that HairClone is trying to use the best possible hair cloning technology on earth and they want to start offering that technology to customers later this year or early next year. If that is the intention then is HairClone paying attention for new developments/information from hair cell researchers that will be reported throughout the year, especially at the Hair Loss Congress?
A Yes we are very aware of the work that is going on but your original comment isn’t correct. A full answer to this question would require a detailed discussion of the regulatory systems in the various countries of the world. We want to be in a position for clinicians to offer treatments as soon as they can but we can’t attach a time frame to that at this moment.

Some other issues I would like to raise:

Q. If a breakthrough is reported someplace such as the Hair Loss Congress will HairClone talk with the researchers involved to try to work out n agreement to use that technology now on paying customers by the end of the year or early next year, while the researchers who own that technology continue taking it through clinical trials? If not, then I see no point to your effort or your HairClone’s existence.
A As well as looking at what others are doing we are also working on our own systems and as I mentioned we can’t define actual timelines to this. We are definitely open to collaboration agreements if they make sense to everyone involved.


#10

Otter. No we aren’t using iPS cells but we are keeping it proprietary at the moment as to what cells we intend to use.
yes it will be an autologous treatment but it will require special approval. The UK has one of the best regulatory positions. The approval that you mention is a “Marketing Approval” and there are exceptions here that allow clinicians to provide treatments to patients under special circumstances that can happen without a marketing license. Obviously treatments wouldn’t be offered by clinicians until they were convinced as to their efficacy.


#11

Are you even trying to work out an agreement with Dr. Alexey Terskikh? He successfully used iPS cells to growth lots of hair. I recently read somewhere that he wants to move forward with that iPS technology for hair growth. He’s the lead scientist in that (getting old) study at Stanford involving iPS cells to grow hair.

http://www.hairlosscure2020.com/pluripotent-stem-cells-used-to-grow-human-hair-in-mice/

I really don’t understand science:

  1. Here you have a scientist (Dr. Alexey Terskikh) who has found a way to solve the inductivity problem and create hair induced cells from mass pass culture. Someday there will probably be more than one way to do this (create hair induced cells from mass pass culture) but right now there is ONLY this one way to do it. While it’s bad news that there’s only this one way to do this, there is some good news because it only takes one way to get the job done. Everybody has already known about this one way for over 2 years but for some reason the idea has stalled. And the inventor wants to move forward with it.

  2. you have a new company, HairClone, that is trying to determine the correct way to proceed with cloning hair. If you could achieve mass pass DP cells while retaining inductivity you would have the correct way to proceed. Dr. Alexey Terskikh has a way to do exactly that and he wants to move that technology forward. So why isn’t HairClone simply calling Dr. Alexey Terskikh on the telephone and trying to work out an agreement so we can get this going?

Don’t take this personal but so many times these efforts really seem half-heated. The time for half-measures is over. There has not been a new better treatment for hair loss in over 20 years, since finasteride first hit the market.

Why don’t you just call Dr. Alexey Terskikh, hammer out a deal, and let’s start putting these cells into our scalps? Replicel’s going to lap HairClone if HairClone doesn’t jump-start things. Replicel’s hoping to have their cell-based treatment ready for commercialization in 2018 or early 2019 at the latest. .


#12

I think HairClone should consider using iPS cells. But if HairClone isn’t using iPS cells then you’re likely using DP cells and in that case you will need to solve the inductivity problem, which is the same problem some other hair researchers are working on. And those other researchers are likely ahead of HairClone in that research because HairClone is new. I think that a breakthrough for this problem may be reported sometime this year. I’ve already seen some recent studies indicating that scientists are closing in on this objective with other hair cells.

Unless you plan to secure temporary rights to that technology and offer it to patients immediately after that breakthrough is achieved/reported (while the main owners of the tech continue taking the technology through clinical trials) I don’t see where you can bring the technology to patients any sooner than the main owners of the technology can.

Will you please clarify how HairClone would offer us that technology sooner than the main owner will?


#13

Jarjarbinx. I hope to be able to provide answers to questions on this forum but I will not be able to enter into such detail discussions.
Patient safety is our number one concern and there have been questions raised about the safety of iPS cells. Studies have found that even autologous iPS cells raise an immune response for reasons that are not understood and the first human clinical study with iPS cells was stopped after one patient was treated because there was some genomic changes to the cells. The regulatory situation around iPS cells is unclear and people are being very cautious. I think it will be many years before they are comfortable enough with the technology to allow it to be used it what they would consider to be “cosmetic” indications.
There are several groups working hard on developing cell based treatments for hair loss and it isn’t a “winner takes all” situation. I certainly don’t wish to discuss these other group’s plans and situation but between all these groups, I hope that we are able to develop an efficacious treatment. Our contribution to this endeavour is our combined experience of many years in both scientific and medical innovation related to cell therapies combined with our experience of the UK regulatory system and environment.


#14

I definitely understand now why you can’t use iPS cells and I also understand why Dr. Alexey Terskikh’s technology has stalled.

That aside, I still don’t understand why HairClone’s strategy is potentially better for patients than just letting Replicel bring us their treatment in 2018 or early 2019 at the latest. And Tsuji anticipates marketing in 2020. And then there’s other researchers who are working the DP cell angle of hair growth and just need to find a way around the inductivity problem and those researchers appear to be close. I think 2020 this nightmare will be over. If you can solve the problem sooner then I would be interested in HairClone but I guess at this time you can’t reveal enough details. I guess I’ll just wait and see what happens.


#15

Thank you for the opportunity to ask you some questions about this promising endeavor, Dr. Kemp. By the way, I think your distinction of the dichotomy of “Scientific Innovation” and “Medical Innovation” is brilliant, and a very accurate reading of the general regulatory and financial influences on biomedical research. I have never heard it described in that way before, but it’s quite accurate. Compliments for getting the general framework for practical medical research right!

Here are my questions:

  1. With respect to the concept of “hair cloning”, it’s generally accepted that the idea falls into two basic categories (which may not be mutually exclusive): “de novo” hair follicle generation, and the rejuvenation or enlargement of existing hair follicles. Will your work concentrate on one of these, or both? Is there a way of knowing, in advance, which of these paths your primary efforts will take?

  2. Another way of categorizing hair multiplication efforts is that some research has been concentrating on culturing dissociated cells (like Dermal Papilla cells and others) – this is the approach Intercytex and Aderans used – while other research has concentrated more on a more gross manipulation of donor follicles, bisecting donor follicles into smaller pieces, etc. (As you know, Dr. Coen Gho in the Netherlands has done a lot of research into the latter approach in recent years.) So, the first approach is along the lines of “cell therapy”, while the second approach is more of a more sophisticated advancement of the field of hair transplantation. Which of these two approaches will HairClone primarily focus on? Do you think one of these two approaches is more promising?

  3. Are you familiar with the research of Dr. Xiaowei “George” Xu, MD, PhD, associate professor of Pathology and Laboratory Medicine and Dermatology at the Perelman School of Medicine, University of Pennsylvania? He says both epithelial stem cells, and the more specialised Dermal Papilla cells are necessary to regenerate hair follicles – and you can’t accomplish this without using both types of cells. Here is a quote from Dr. Xu: “When a person loses hair, they lose both types of cells.” Xu explains. “We have solved one major problem, the epithelial component of the hair follicle. We need to figure out a way to also make new dermal papillae cells, and no one has figured that part out yet.” What do you think of Dr. Xu’s explanation here, and will you be incorporating this knowledge into your work at HairClone?

Thank you again, Dr. Kemp! We really appreciate your time and your answers!

Roger


#16

Roger
Those are really good questions. With our approach we can, and have already started, testing these alternatives. It is important to not only find something that works but the economics and practicalities of culturing cells, combined with the different regulatory situation in the various countries also have to be taken into account. All these things are trade-offs. The more a cell is culture expanded the more potential follicles could be regenerated or rejuvenated but this is tempered by the fact that it has been shown by several groups that hair cells are altered in culture. However, there are now transciptomic assays available to quickly monitor these changes and thus test a variety of culture systems and develop ones that minimise these changes. A single cel type is obviously easier, and cheaper, to produce than multiple cell types, but as you rightly point out, some people suggest at least two are needed. Cell suspensions are easier to produce ship and implant than follicle rudiments, but again ease/cost vs efficacy is a factor. Rejuvenation is possibly an easier first target than regeneration, but although that rejuvenation of miniaturised follicles would benefit some patients, others would need a regenerative treatment. Finally, should a therapy be developed to replace hair transplantation or augment hair transplantation and allow surgeons to cover larger areas and produce a more cosmetically helpful treatment. It is very clear that “one size does not fit all”. Different patients have very different needs and it is also very clear that treatment systems can develop with time as the scientific advances occur in step with the clinical advances.
Hair Transplant surgeons have made tremendous advances in their technical abilities to move hair follicles, we are trying to provide systems=at first simple systems= to improve the abilities of our clinical partners to achieve a better cosmetic outcome for their patients and then to build on these first steps together.


#17

Roger that is a good question about the potential need for both cell types. What do you think about that? I dismissed that idea because Dr. Jahoda grew good quality hairs on his wife’s arm with DP cells alone. Hence, I think DP cells alone will do the trick and we only need to find a way to culture enough of them to cure hair loss IMO.


#18

@jarjarbinx, Dr Jahoda found upon analysis of the chromosomes in the hair follicle on his wife’s arm that it was a hybrid or more precisely a “chimera” having some cells with male chromosomes (XY) and some with a female set (XX). So it’s obvious that the injected DP cells were inducing cells in his wife’s arm and combining to make a follicle.

It seems Dr Xu is talking about regenerating new follicles (de novo), which is not dependent on having an intact miniaturized follicle at the site. So to create de novo follicles, it seems that you have to have both stem cells and DP cells.

To simply induce a miniature follicle to grow larger or be rejuvenated, I think this could be accomplished by DP cells alone; although it is probably more effective when both DP cells and stem cells are used.

I think there are even MAJOR differences between bald individuals. Some bald or balding people have relatively intact miniaturized follicles which may be rejuvenated by just adding DP cells. But for others, the follicles may have been so damaged, disrupted, etc. by the androgenetic alopecia process, that it takes more than just adding DP cells to revive them. They may also need stem cells; or they may not be amenable to rejuvenation at all – with those people you’d just have to create de novo follicles for them. Unfortunately, there may not be a reliable way to predict how amenable patients might be to either of these strategies, because one can’t visualize the microscopic state of the follicles with the naked eye.

Therefore maybe one of the problems with Intercytex and Aderans may have been they just assumed “one size fits all” – that if they developed a good treatment, it would be reliable and work more or less the same on every balding person.

My suspicion is that is NOT the case. Two people who may visually have the same balding pattern, have been losing hair for the same amount of time, etc., may have follicles with dramatically different degrees of “health” on the microscopic level. So, for some, adding DP cells might be enough to rejuvenate existing follicles. For others, maybe you can add all the DP cells you want, but you’ll get little or no rejuvenation, so you have to go with de novo follicle creation.

Bottom line is, I think as Dr Kemp said above, “one size does NOT fit all”.


#19

Thank you for answering our questions.

Can I ask how much does a typical “cell bank” cost and how far are you from raising that capital to set up the first hair bank in the UK?


#20

Typical cell banks cost around $2,500 for 20 years’ storage. They classically have financing models that allow some of this cost to be spread over time. We intend to partner with an existing banking facility so we won’t need the cost of building a new facility and we are in discussion with possible partners. HairClone already has sufficient funding to start this and the rate limiting step will be obtaining the licenses that we need from the UK’s Human Tissue Authority.