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

James Bond, it looks to me like Dr Terskykh’s iPS cells can grow hair.

It’s too bad that isn’t be explored any further…

And James Bond, here in this study Jahoda and Christiano claim to have used cells to grow hair. Are you saying that they’re wrong?

It IS being explored further. Dr Terskykh is trying to raise funds to advance his research.

Dr. Kemp, here is a VERY recent interview with Dr Terskykh about iPS cells. In this interview he tells how to contact him if you decide you want to contact him.

Yeah, if they are still doing research and are tight on funding, any possibility of a treatment from him to hit the market will take another 15 years. Too long for me.

Yes, the cells grow great hair in mice. Of course, so did Aderans cells. Unfortunately, they went bust after investing perhaps $150 million trying to get the same process to work in humans.

Let’s keep in mind, Terskykh’s research is unfunded, it has not yet been proven safe in humans, and nobody knows whether the new follicles will be subject to the effects of DHT.

This is promising research, but there’s not a snowball’s chance in a desert that this treatment will be marketed within the next five years. I’m keeping in mind, it could be marketed within five years, but I can confidently tell you that it won’t.

I just don’t get where people are drawing a line between completely unfunded research that hasn’t even began human trials yet, and a cure based upon this research being released in a year or two? Come on you guys, this just is not realistic.

No, I’m saying this research resulted in growing hair in mice using DP cells. Well, so did plenty of experiments from 30 years ago. As it turns out, growing hair in mice is quite easy compared to growing hair in humans. In fact, Jahoda showed in 1999 that non-cultured DP cells implanted directly into a human subject did not result in any hair growth at all.

I’d be far more impressed with a single study that uses non-cultured DP cells to consistently grow hair in humans than I would any study that results in hair growth in mice using cultured cells. Yet, 50 years after Dr. Oliver’s original proof of concept in rats, not a single study exists that proves the research translates well to humans. However, there are numerous studies showing the research does not translate well to humans.

We’re taught from birth to obey the rules. This makes it extremely difficult for anybody to think around them. In order to do so, we would have to untrain ourselves of every single thing we know, and start training ourselves from scratch using a non-obedient philosophy. Who in they’re right mind wants to do this? It’s not that it wouldn’t be a superior way to live and think. It’s just that it’s a lot more comfortable to sit on the couch, watch TV, and become programmed by others.

At the end of the day, it’s far easier to clone an entire generation of human minds than it is to clone a single hair follicle stem cell. Otherwise, we would have never lost a single hair in the first place. Since this isn’t the case, the cure is not as close as many suppose.

James it was human cells implanted into human skin that was grafted to mice.

Yes, severely immune compromised mice are relatively easy to grow hair on, even when using human DP cells injected into grafted stem cell-rich human neonatal foreskin. Then again, vehicle alone has been shown to grow hair when placed onto human balding skin grafted onto SCID mice. So just about anything will grow hair under these conditions. Thus the recent buzz about the potential for ruxolitinib and MPB.

The point is, news headlines and magazine articles sell stories, so they should be read and considered carefully. If Jahoda’s 2013 research was a legitimate cure, we would already be in phase I studies. Unfortunately, although Jahoda was able to improve yield using 3d culture methods, the yield was nowhere near that necessary to commercialize the treatment in humans.

The following timeline would be necessary if a serious effort to commercialize Jahoda’s latest research were to start today:

  1. Getting a much better yield of amplified cells (minimum 3 years including obtaining funding)
  2. Phase I studies to prove safety (minimum 2 years)
  3. Phase II rolling studies (minimum 2 years)
  4. Phase III studies (minimum 2 years)

Time to market is a minimum of 9 years, so let’s round it to 10 including FDA review. And let’s keep in mind, so far, nobody has been able to (publicly) demonstrate that uncultured DP cells will consistently grow hair in non-immune compromised humans. Therefore, nobody is in a hurry to invest in attempting to commercialize this research. In short, a whole lot of lab work needs to be accomplished prior to the VC moving in.

At the end of the day, human DP cells work great in SCID mice. And using stem cell-rich human neonatal foreskin is not a true representation of balding adult scalp skin. Thus, Dr. Kemp’s proposed alternative research effort looks much better than the news stories would lead you to believe.

It was known at the time, that Jahoda’s 2013 research was not a cure. It was understood that while it did protect some inductivity; it did not protect enough inductivity. Researchers need to find ways to protect more inductivity.

I think that if researchers found a practical way to create sufficient supplies of these hair cells today that method could enter human studies this year and it could be available in 2019 or 2020 in Japan, where cell-based treatments get to market quicker. So I do not think it would take 9 years.

It’s already taken 4 years.2020 is highly unlikely for this particular research group. But even if it were released then, it would have taken 7 years total.

When I brought this up in 2013, not too many people agreed with me. But then again, they’ve already blown past their original timeline for a cure to have arisen from this particular research, so I’m looking more correct every day.

We need smart, experienced, and highly talented researchers like Dr. Kemp to go all in with bold new approaches. Otherwise, we’ll all be looking back a decade from now and still waiting for a cure.

It’s really surprising to me that Dr. Kemp has faced initial resistance from some members of this group due to their belief a Brad Pitt hairline is only a year or two away. As if there’s no need for new research at this stage of the game because others have already figured it out. Well, I hate to be the bearer of bad news, but nobody has figured it out yet.

Because anything in the research phase won’t be on the market for another 15-20 years. That’s why. In 15-20 years I’m going to be 50-something and not give crap about my looks most likely. I would like something to enjoy my youth, while I’m still young. That’s why this shit pisses me off and that’s why everyone has their eyes set on Japan. You have Tsuji’s team who is well funded, close to a cure, and a relatively lax regulatory system to be able to bring to market. If Dr. Kemp had something now that’d be great, but I cannot donate or care about someone who is offering me a treatment in 15-20 years. Sorry, not good enough. Too late.

Getting back to Dr. Terskykh, I’m wondering about something. He’s sitting on top of what might be the best approach to a cure (creating de novo follicles is a certain way of regrowing a full head of hair, as opposed to rejuvenating miniaturized follicles which for many reasons, is hit or miss.)

Dr. Terskykh is also sitting on top of lots of money. San Diego developer Conrad Prebys recently donated a $100 million gift to Sanford Burnham:

Something doesn’t add up here. Why, in Dr Terskykh’s recent interview, is he talking about trying to get someone to do a crowdfunding campaign to fund the hair project?

Either SB doesn’t think his idea will work for scientific reasons, or for safety reasons (concerns about using iPSCs?), or because their priorities are curing life-threatening diseases, and this procedure has a cosmetic purpose. (When Dr. Terskykh did the initial experiment, it was kind of a spin-off from neurological research he was doing on brain diseases. It may have been a detour in his work that wasn’t entirely sanctioned by SB.)

Why is Dr. Terskykh having such a hard time getting funding for this project? Is he being given ANY kind of support from SB to pursue this – even pointing him to potential donors? Why is he waiting for someone to start a crowdfunding campaign? And, if that’s the big stumbling block, why hasn’t it already been done?

I think you hit the nail on the head here for why SB isn’t supporting him “…or because their priorities are curing life-threatening diseases, and this procedure has a cosmetic purpose.”

In 1980, there were a lot of people saying the cure for cancer was less than a decade away. In fact, I remember hearing it on the local news numerous times. I was a kid back then, so 10 years seemed like a long time to wait for something that seemed so necessary to humankind. Four years later, my mother died from cancer.

In 1988, Rogaine was released as a prescription for hairloss. Although, my own hair loss had not started yet, I remember reading numerous articles claiming a cure for baldness would be found within 10 years. At least I could rest assure I would never die of cancer and never lose my hair.

In 1999 I was losing my hair, and the promised cure was nowhere in sight. Then, Jahoda grew hair in his wife’s arm. I rejoiced. A miracle cure was just around the corner!

Soon after, Aderan’s invested huge sums of money into a stem cell cure. Intercytex was working hard on a cure. Numerous other scientists were hard at work solving the problem. It seemed impossible that we would not all have Brad Pitt hairlines within 5 years.

The only thing to be depressed about was, it was going to take a lot of energy to fight off all the surplus women who followed us around everywhere we went and begged for our affection. Imagine all the hard work it was going to take to have 3 or 4 girlfriends at the same time and attempt to keep each from finding out about the other. We had serious philosophical issues to solve in those days.

But the promised cures never came. We’re about 40 years since the prediction for the cure for cancer…people are still dying. We’re about 30 years past the prediction for the cure for baldness…people are still bald.

My advice is to ignore news stories about magical cures, and read claims from companies with a critical eye. The truth is in the existing research papers of our time.

Dr Terskykh is at least a decade away from a cure. Dr. Jahoda will never figure out a cure. Yes, there is a lot of hope for a cure coming out of Japan, but so for, it’s just a lot of hope for a cure.

Given the conditions of our current state, I believe telling one of the most preeminent hair research scientists in the world to not bother looking for a cure is a less than well though out decision.

@_JamesBond - James are you including Dr Kemp and HairClone in this pessimistic scenario of “at least 10 years” or “never”? Or do you see Dr Kemp as being in a completely different category from the others?

Actually, Dr Terskykh’s process is a MUCH different process than Aderans. Not even really close. Dr. Terskykh’s process involves using iPS cells to generate non-expanded DP cells (without any loss of inductivity) which, along with other cells, would become part of brand new, de novo follicles. Aderans was injecting cultured DP cells in the hopes that these would rejuvenate miniaturized follicles or generate new ones (Aderans wasn’t even sure of which of the 2 scenarios would happen, themselves).

I’ve thought long and hard about this, and you know what i think the limiting factor is, that killed both Aderans and Intercytex, as well as other efforts, and probably will torpedo Replicel as well? I think the limiting factor is the receptiveness of miniaturized follicles on a MPB scalp to being rejuvenated at all. I think that even where many miniaturized follicles appear to be intact, just shooting DP cells at them will not ensure that they become terminal. Most are not receptive to this, and will never be receptive to it. So this particular angle is really a lost cause. I think that in most people with MPB, most of their follicles reach a certain point in the process where just adding to the number of DP cells (assuming that the injected DP cells even attach to the follicle, which is by no means a given), will not cause them to regenerate into a fully functioning, healthy terminal follicle. Most MPB follicles after a certain point are for all intents and purposes, dead.

The reason why so many researchers (ICX, Aderans, etc.) thought rejuvenation would work is that it worked SOMETIMES… that is, a very small percentage of the time. So, let’s say they had a patient and injected some DP cells, and on his entire bald scalp, 10 new hairs grew. I think that led them to believe (wrongly) that if they tweaked this idea in just the right way, they’d end up with a procedure that could restore a huge cosmetic benefit to the patient.

But, what if those 10 rejuvenated hairs are all you can get? And what if the biggest problem is not so much the cells that you’re injecting, but the follicles your’re trying to revive?

All that leads to one conclusion, then: Instead of focusing on trying to revive/rejuvenate miniaturized follicles, maybe the best way forward is to just grow brand new follicles from the proper constituent parts?

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.

My timelines are not pessimistic.They’re realistic.

Agile development uses the concept of “velocity.” You can use your team’s known velocity to estimate the amount of time it takes to deliver future products. Let’s take a look at Replicel’s velocity.

2003 - McKelwee injects fluorescent DSC cells into mice and proves they create new follicles and stimulate existing follicles to grow thick hair.
2009 - McKelwee (Replicel) designs his first study in humans - Phase 1/2a
2010 - Approval to perform study granted, First patients are injected.
2011 - Final patients injected - 24 month followup began
2012 - Phase IIa scheduled to begin. However, the study never commences because Replicel needs to invest it’s limited funds in other areas in order to hedge it’s bets in case it’s hair growth fails. Otherwise investors will get cold feet and pull out.
2013 - First study in humans concluded. Shiseido enters into agreement to license the technology.
2014 - Shiseido sets up facility in Kobe Japan in order to fast track product to market.
2018 - Shiseido’s target delivery date for availability of product to the public.

As we can see, Replicel’s velocity to deliver it’s product is projected to be 15 years from the proof of concept studies through to market availability. Of course, the research could hit a snag and take longer or not be delivered at all. But let’s say the product is delivered at the 15-year mark. What can we expect in 2018?

Probably between zero and 25% increase in density with additional density being provided through additional treatments. However, the 25% responders are outliers, just as the zero responders will be. The typical increase in density will be about 10% to 15% per treatment with results possibly tapering off through time (maybe only 7% density increase in treatment 2, etc). Future versions of the product will bring increased density per treatment, which would offset the taper-effect.

Replicel’s treatment looks promising. However, it will be nowhere near the Brad Pitt cure via a single procedure people are expecting. Reason being, the fundamental hurdles to this process have not been fully overcome.

As for Dr Terskykh, he has no funding, he’s still studying mice, and he’s nowhere near starting a trial in humans. People who think his research will be available to the public in a year or two need to take a look at his velocity to date and base their projections on that. We can learn from Gho, Replicel, Aderans, and Intercytex that velocity in mice occurs relatively quickly. The problem is maintaining this velocity once you get to human experiments. Also, as Dr. Kemp points out, the problem is not simply with the research itself. Many other factors are involved, one of which is satisfying investors. Of course, if we try to release it in the US, we have the FDA to contend with and many other potential hurdles.

I love Terskykh’s method. However, it’s safety has not been proven, it’s not been shown to work in humans, it has zero funding, it’s unknown whether it’s subject to the future ravages of DHT, and Terskykh will probably try to take it through the FDA. This research is comparatively at about the same level of maturity as McKelwee’s research in 2003. Although a different product, It still has a long way to go from here to market.

Dr. Kemp’s research will draw-from, piggyback, and enhance upon other research. Thus, let’s say, in 2018, you go to Japan and get Shiseido’s treatment and get 10% regrowth. Then you go back in 2020 and get another treatment but simply break even due to the taper-effect and your own continual loss of hair. But by 2023, HairClone has developed it’s procedure using fast-track agile techniques. So you get it and wind up with a 35% pop in your density. Another Shiseido patient who was a zero% responder goes to hairclone and gets a 40% increase. I go to HairClone and get a 10% increase. So I go to Shiseido and get a 35% increase.

It’s important to keep in mind, human beings are biochemically unique. What works for you, might not work for me. Therefore, it’s important during the early market stage of these treatments that we have a variety of techniques to choose from. This also drives down the cost to the patient.

In order to succeed, HairClone will have to satisfy investors, much the same as Replicel. But it must satisfy it’s investors in a different way. It will need to concentrate on a single treatment area (hair), and it will need to deliver results early and often. Dr. Kemp must become the Craig Venter of hair, where results matter far more than fitting into the neighborhood.

baldings,

I’m over 50 (although I’m told I don’t look it) and I can assure you of this: you will still “give a crap” about your looks when you’re in your 50s and beyond. Here’s the dirty little secret about aging: your mind ages much more slowly than your body. When you’re 50, you will still feel 35-40 (in some ways even younger). In fact, you will be asking yourself where the time went. “It seems like only a couple of years ago that I wrote that post on Hairsite saying I wouldn’t care what I looked like at 50!”

Wait and see. :wink: