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

Believe me, JB, I know what you mean about envying guys my age who have all their hair. I have been known to look around the room at work and see how many guys have MPB and how many don’t. haha

If I had it to do all over again, I would just shave my head, grow some kind of beard, and wait. Jason Statham is a cool looking guy, after all. Because I jumped into a HT in my mid-20s and have scars and some unnatural looking mini-grafts (thankfully hidden behind better work now), shaving my head isn’t an option anymore. I look okay and can still get compliments and dates with attractive women, so I shouldn’t complain. But my quality of life would have been better all these years if I had never had a HT or had only had the modern FUE variety.

baldings, I wasn’t offended. I can still remember being young enough to think my 28-year-old sister-in-law looked old because she was starting to get crow’s feet! Now I see 60-year-olds that I think are hot (rarely). :wink:

[quote=“roger_that, post:101, topic:27388”]
THAT is what Dr. Terskikh and Dr. Tsuji are trying to do. And that is what clearly sets them apart from Aderans, Replicel, Intercytex, Gho, etc. in my opinion.
[/quote]Your hypothethis of non-receptive miniaturized follicles is interesting.

Certain treatments (including vehicle alone) have been shown to revive miniaturized MPB follicles in human skin grafted onto immune deficient mice. So how about hitting the body with some immunosuppressants prior to injecting the heads with hair reviving cells? IOW, the miniaturized follicles might be resistant to stimulation as is, but there might be ways to make them become more receptive to the injected cells.

Also, McElwee’s injected cells created new follicles and stimulated existing miniature follicles. So perhaps Shiseido 's treatment could be tweaked to work, despite resistance to stimulation?

Dr. Kemp:

Can you tell us your thoughts about your proto-hair experiments and their potential on humans? Is this something that’s a long ways out? So for instance, developing a cellular injection treatment would take precedence over your research into exploring the possibilities of a proto-hair treatment?

Also, I see that buying stock in HairClone appears to be a possibility. Is this correct?

Thanks!

I highly doubt that, it is still so early in the game for HairClone; they have zero revenue right now, and besides do you think this makes a good investment ?

Definitely sounds like an idea worth trying.

My suspicion, though, is that it’s not an immune-related problem, but rather one (or both) of the following:

  1. MPB follicles subjected to DHT for a long time lose not only size, but also some structural integrity, making them very bad candidates for rejuvenation. Even if all other conditions (injected cells, physiological environment, immune system) are optimum, maybe the injected cells can’t help grow the follicle because MPB follicles have had their structure so degraded after a while, that it’s like trying to use a handful of bricks to rebuild a house hit by a tornado; OR

  2. Maybe (as I’ve long suspected), injected cells have a poor affinity to adhere to and incorporate themselves into follicles. I am not saying they have zero affinity – just a considerably smaller affinity than people like Dr. Washenik, Aderans, Intercytex, etc. anticipated. So, if they based their research and clinical trials on the assumption that injected cells would cause a massive improvement by almost always incorporating themselves into follicles, they were mistaken. Whatever preliminary testing they may have done provided only anecdotal evidence, that they then extrapolated into something much more effective than it actually is. Like I said, maybe in the course of all the testing and one-off experiments on human tissue, they saw SOME growth. Perhaps they assumed that this growth was an indication that with just some extra tweaking, they could get much better yield. But remember, in biology and medicine, data on cell behavior is distributed more on a bell curve. It’s never absolute. So, they were focusing on the results at the far right end of the bell curve (the few cases where injected cells were just lucky enough to adhere to and incorporate themselves into follicles), while ignoring everything to the left of that data on the curve. What I’m saying is, perhaps the vast majority of injected cells don’t adhere to the follicle in the first place, but are just scattered in the extracellular fluid and are wasted. If that is the case, it would be a major challenge to get this to work well – they would have to (at minimum) figure out a way to get more cells to adhere to the follicle. If this problem is mediated by mechanical factors (like Brownian motion within the extracellular fluid), or simple lack of affinity of the cell membranes of the injected cells for the cell membranes of the dermal papilla (which of course is the true target and is well protected by a sheath and epithelium), then it would be a huge challenge to figure out a way to circumvent those problems.

I’m referring to the following from HairClone’s website:

“Patients and clinicians will be invited to invest in order to support the research and development in return for equity in HairClone.”

For me, it makes sense to either donate money toward HairClone (small amounts) or invest in the company (larger amounts). Perhaps for others it makes more sense to bank follicles or do nothing at all.

IMO, investing into HairClone is a good investment for everybody, even if you simply donate $100 and walk away. Far too many people complain about how they’ve been unfairly shortchanged by MPB; thus, other people owe them a living. These people never lift a finger to do anything about their condition. The only thing they’re good at is spreading negativity and dread.

I’d prefer to leave the dead to bury the dead. Instead of feeling sorry for myself and dragging down others, I’d prefer to help back a team with the knowledge, experience, and ambition to do something about my condition. And if it doesn’t work out, at least I did something with my life other than complain and feel sorry for myself while attempting to destroy the well-being of others.

From where I’m sitting, the fabulous Riken hasn’t exactly called me up and asked me to become a member of their research team. Who else is going to ask me to become a partner in attempting to find a cure? The only real offer I’ve ever seen is from HairClone.

People tend to see Dr. Kemp’s research as “too late” to be of use. It’s as if, there’s a guaranteed cure on the horizon, so nobody else should even try. According to these people, in two years, we’ll all be Brad Pitt. The reality is, two years from today, we’ll still be bald. The best we can hope for, is an interim treatment to come out soon that gives us some increased density while we wait for a real cure to emerge.

What I like about HairClone’s plan is they can inject multiplied hair cells into patients on a case-by-case basis without having to enter into formal government-regulated trials. This is a game-changer, as it allows them to garner immediate and ongoing information while they simultaneously work on figuring out how to keep multiplied cells from turning into non-viable cell types. IOW, it provides them with similar advantages while working with humans that they have enjoyed in the past while working with mice. I’ve lost faith in the make it work in mice, from this design studies in humans, and lock into a single protocol upfront for the upcoming 5 years and never deviate from this protocol until the five years is up approach. No offense to those that cling to the old model, but I see it as needing about 20 years to be successful, and then it will only give us an imperfect treatment until additional research is performed.

IMO, HairClone should use the concept of paying to be experimented on. In this scenario, MPB sufferers would pay for a portion of the cost of having themselves injected, even early on in the experimental phase (for instance, prove non-cultured DP cells would result in a cure if you had an unlimited supply.). The other portion of the cost would come from various other funding sources. What does the patient get? Early knowledge of how their body responds to treatment. What does HairClone get? Its research becomes self-sustaining.

I believe HairClone will be successful is if they take on patients as partners, and they begin to deliver results to their partner-base early and often in the game. The pace of discovery will mirror the pace of investment. The two are married at the hip. Should one or the other falter, so shall the other.

Sounds more like a private placement, or an open invitation to angel investors.

Not to knock Riken, but I don’t see evidence of them ever having done human experiments. The recent research appears to be immature:

And the explanation on their website appears to make the research look even more immature. I’ve seen similar pictures from the 1960’s research (Oliver comes to mind). I see nothing mature about Riken’s research other than the promise of a newly discovered 3d culturing method.

Howe does Riken propose getting from the images on their website to releasing a successful treatment in 3 short years? I’m not being cynical here. Can someone who understands it better than I do explain how it can be done. From where I’m sitting, it appears to me to be an impossible dream.

JB. Thankyou again for the kind words. I think producing protohairs is one very promising method to forming hair structures and we were heavily involved with that at Intercytex. We were just beginning to produce human protohairs but we weren’t able to raise more VC funding in the '08 banking crisis. This experience really made me very reluctant to repeat the model of raising development funding through this route again and led to HairClone’s business model.

(see mouse work we did with protohairs in Hair morphogenesis in vitro: formation of hair structures suitable for implantation. Qiao J, Turetsky A, Kemp P, Teumer J. Regen Med. 2008 Sep;3(5):683-92.). When we were doing this work, manufacturing cost and complexity, implantation and hair direction of growth were all concerns of ours, but but these will all get addressed once a successful system is developed. As I have said previously, cell based treatments will not be a one-size-fits-all and different patients will suit different treatment options from cellular rejuvenation of miniaturising hairs, induction of in-situ follicle neopgenesis and growth of implanted photo-hairs.

As to buying stock in HairClone, we are working on developing ways that people could do this, but offering shares in a Company is a heavily regulated process and rightly so. We already have approval for one system from the UK regulatory agency termed SEIS, but this is only open to what the UK Govt term as “Qualified Investors” i.e. High Net Worths. For smaller investors, we are in discussions with Crowd Funding Platforms who are authorised to carry out Due Diligence on Companies. Many people around the world have registered interest in this via our website and hopefully we will be able to offer that route soon.
Leading hair transplant surgeons are already supporting our work (see our website for a list of these Partners) and we also intend to be able to offer the banking service soon. As you say in a later post “The pace of discovery will mirror the pace of investment” and we are working hard to develop this ongoing partnership between interested patients, clinicians and scientists.

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I totally agree with you James. At this moment it is pointless to talk about Tsuji, since they are not even into clinical trials. Pretty much everything they are talking, it’s written in the sky from realistic application point of view. Even their projected date of commercialization of a product is rather ambition than a realistic schedule.
In my view, even if in three years they are going to start clinical trials, they won’t be able to offer treatment at least till 2025. And that’s provided they cracked all the issues. There is no magic bullet here. Every researcher is subjected to the same trial and error process which takes time. There is no way to navigate round that. Japanese regulatory might help the process to be simpler but not necessarily shorter.

@PKemp @jarjarbinx

Good news!

http://www.sciencemag.org/news/2017/03/cutting-edge-stem-cell-therapy-proves-safe-will-it-ever-be-effective

Dr. Kemp, does this say that you team (HairClone) has already starting implanting the cells into people’s scalps in the UK? If you are then why don’t we all just do this now?

If I understand this correctly Hairclone aims to produce first an injectable method that may help existing hairs and maybe sprout a couple of miniaturized ones and maybe in time as research progresses move on to a complete reversal technique? Horshoe to Chia pet.

The article you mentioned followed an interview with one of our Clinical Partners and discussed our plans for the future. What we can do at the moment is limited by the regulatory system here in the UK and we are currently looking at implanting just a few cells in patients to determine what are the most suitable cell type or types to expand, the optimum way of implanting them and the best way of measuring the results. I appreciate people’s eagerness to have a treatment as soon as possible, but we feel this steady approach is the optimum way to provide the information for the best way to move forward and we are already learning a great amount.

Hello Dr @PKemp . I have a question about something that I’ve been thinking about for a while.

The idea that injecting dissociated DP cells into the scalp could result in a considerable “boost” to miniaturised follicles is predicated on the assumption that for any given injection, a significant portion of the cells will “hit the target”, adhere to the follicle in the dermal papilla zone, and become anatomically incorporated into the follicle. This would lead to a permanent increase in the number of viable DP cells in the follicle, which would lead to a larger ,healthier follicle and the growth of terminal hairs.

But, what if it’s not so simple? How do we know this is the likely outcome of injecting cells?

To my mind, it seems that there are a number of mechanical, physical, anatomic and physiological obstacles that have to be overcome in order for this method to work well. When dissociated cells are injected into the skin, they each can take one of several paths. One possible path is that, because it’s very difficult to ensure that the payload of an injection hits its intended target with micro-precision, the cells never get close enough to the follicle base. In other words, despite injection procedures which are thought to be careful and precise, the injected cells altogether miss their target.

Another possible path is that the cells land near the follicle, but most of them still get washed away in the interstitial space, by intercellular fluid, and never become associated with a follicle. Another possibility is that the cells are seen as a foreign body (even if they’re recognized as histologically compatible being from the same patient), and they get eaten up by macrophages or otherwise incapacitated by the cellular defenses of the immune system. A fourth possible path is that a good fraction of the injected cells are fortunate enough to stick to the follicle for a while, but only a very few actually get incorporated into the follicle. For cells to become incorporated into a follicle, are there not obstacles, such as the epithelium of the hair bulb, that would have to be breached, so that the injected cells can affix themselves to the proper spot at the dermal papilla?

My concern and question is that it seems there are so many obstacles and uncertainties involved, that we are still not really sure whether this approach will work very well. Even if there’s anecdotal evidence that it can work sometimes, maybe we are seeing what happens when 10 in 10,000,000 cells are lucky enough to reach their target, avoid and penetrate all obstacles, and incorporate themselves into the targeted follicle. But perhaps this anecdotal evidence of “success” obscures the fact that the vast majority of the injected cells will never reach their targets and unite with follicles, and purely for physical, anatomic, physiological or mechanical reasons?

If that is true, then increasing the inductivity of the cells, by itself, would not actually solve the problem, in my opinion. It could be that the wrong problem is being targeted.

What do you think?

Roger

Thankyou for your very informed question. You raise some very plausible modes of failure and this is one of the main reasons that we want to take it carefully step by step with human studies. If there wasn’t the various pieces of evidence down over the years that this can work to some degree and the critical fact that the hair follicle is a naturally regenerating mini-organ, then a cellular strategy would perhaps not be appropriate and we wouldn’t have formed HairClone. We are of the opinion that this evidence shows that it is possible and that it is the cellular phenotype, or implantation site or recipient response or a combination of all these factors that has, as you suggest, resulted in a sub-optimal (but very importantly not zero) clinical response. All the potential modes of failure are addressable when we know which ones are in fact involved and we are currently beginning to look at all of them in parallel. I agree with you that merely increasing the inductivity of the cells by themselves may not be enough to solve the problem.

That is reassuring, @PKemp, and I am confident that despite the obstacles, you have hit on the right path in doing this research. I think what you mentioned about the hair follicle being a self-regenerating mini-organ, suggests that there is an inherent capacity of the follicle to respond to anabolic stimuli. You’re on the right track with this “parallel” research approach, of discovering just what stimuli are required. Thanks and enjoy the holiday weekend!

I absolutely, totally, 100% respect every last word you have posted at this site. But I have been dealing with hair loss for decades and I’ve had all the fun with this nightmare that I can stand. It’s an emotional issue and I’m fed up with watching my life be destroyed, especially in a totally screwed up world that doesn’t get it that something bad and life-altering has happened to me.

People act like we bald people should still be able to do the things we used to do when we had our hair. For example, I used to EASILY pick up a different attractive woman every night at the clubs and people are acting like I should still be able to do this now without my hair. What a joke. Just how stupid are people anyway?

I want this nightmare over asap.

Take 10 patients and isolate uncultured cells from their donor and reinject them into the balding area. Do the same in a different part of the balding area with medium passaged cells. Now do the same in a third area with unpassaged cells using a “flooding” technique. The latter technique is akin to using the brute force method in order to get around the potential issues you mentioned above.

Strategically advertise your “proof of concept” results for a cure for MPB. Within one year, you’ve proven what’s needed to cure baldness, and you’ve collected plenty of seed money to get a good start.

@James_Bond Agreed, that would be a quick and cost-effective study that a researcher like Dr. Kemp could do, to determine once and for all whether the cell injection method will ever bear fruit. Good suggestion. I hope that he, or someone, will do this.