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Last substantial update from HairClone


#1

Was this video from 2017. Did HairClone ever get their patient, Rick Ortega, his hair back?


#7

Also, there is this recent interview with Dr. Kemp from December 2018 –

While I highly respect Dr Kemp, something I would question about a few things he stated in this interview is his continued faith in follicle “rejuvenation”, that is, restoration of miniaturized follicles by replenishment of DP cells.

I think that there may be ample evidence accumulated now to demonstrate that this model DOES NOT in fact work well enough for any kind of marketable commercial application.

I have said this before here. This is exactly the model that was tried and failed in the cases of Intercytex and Aderans Research Institute.

Their model was to culture and inject DP cells into the scalp. Well, it turned out there was a problem (as Dr Kemp mentions in this interview, but he doesn’t seem to connect with the “rejuvenation” model). The problem is that the DP cells, if used by themselves, lose their inductive properties when cultured.

Not only that, I think there is a larger problem (which I brought to the good doctor’s attention here a while back, and he seemed to acknowledge it, but I think he’s ignoring now.)

That problem is that the whole rejuvenation model is based on the assumption that when you inject dissociated DP cells into the scalp, they will automatically attach to the dermal papillae of follicles in large numbers, and integrate themselves permanently to become part of those dermal papillae.

This is in fact a huge assumption, and my theory is that this is not really the case. I think the empirical data now suggest that this is far off the mark, and only a very tiny percentage of injected DP cells actually attach to and integrate with miniaturized follicles’ dermal papillae. The vast majority of these injected cells never integrate, and are just flushed away by extracellular fluids and lost. That explains the unpredictability and unreliability of using this method, and it mostly explains why Dr Gho, Intercytex and Aderans failed.

In my view, the reason for the initial excitement over this idea was that some researchers (like Gho) saw that it worked a little bit, so they extrapolated (mistakenly) that it could be somehow perfected to a viable procedure that would work very well.

What they were seeing was the maybe 1 in 1,000,000 times, totally governed by chance, that enough injected cells managed to adhere to and integrate with a miniaturized follicle for it to end up in a visible improvement in the size of the hair shaft.

The problem is there is really no feasible way to turn this into a viable procedure, because there is no known or conceivable mechanism to get more of the injected cells to integrate. They won’t do so because to integrate, at the very minimum, they must precisely hit the dermal papilla after injection, and very few of the injected cells do this. It’s impossible to direct exactly where these cells will go using standard trans-dermal injection techniques.

Even if some of them do hit the dermal papilla, there is still no guarantee that they’ll integrate with it, because there is really no big physiological or cytological reason for them to do so.

If I throw individual bricks at the brick wall of a house, how many of the bricks I throw will integrate with the wall?

That’s maybe a very over-simplified analogy, but there is some truth in it.

The anatomy of the hair follicle is complex, and the area where the dermal papilla sits is pretty well-protected, with layers of specialized cells surrounding it, and a peri-follicular sheath and outer sheath surrounding those.

So tell me, how will you get sufficient numbers of injected DP cells to naviagate and traverse all of these layers and barriers to even reach the dermal papilla, much less get them to somehow spontaneously integrate with it?

I wish you luck with that, Dr Kemp, especially after the documented failures of Intercytex and Aderans, with their multi-million dollar investments, trying to do the same thing.


#8

“This is exactly the model that was tried and failed in the cases of Intercytex and Aderans Research Institute.”

“Their model was to culture and inject DP cells into the scalp. Well, it turned out there was a problem (as Dr Kemp mentions in this interview, but he doesn’t seem to connect with the “rejuvenation” model). The problem is that the DP cells, if used by themselves, lose their inductive properties when cultured.”

I think you haven’t read well into this article.

At the very beginning of that interview Dr.P.Kemp answers why he got inspired to start HairClone. Foremost it was Dr.Higgins transcriptomic techniques which he or K.Washenick at the time of Intercytex/Aderans did not have a clue about. Later he goes to explain:

“with this new approach from the Higgins research there were rapid & sensitive analytical techniques. More importantly, this change in cells wasn’t permanent and if the cells were then put into a 3D environment their gene expression reverted back to some degree to a more DP type and these cells were able to induce hairs.”

It goes to previous topic about C.Angelo&Jahoda experiments using the same techniques recover 70% of inductivity.

So, Intercytex/Aderans and HairClone knowledge and capabilities to recover inductivity of DP cells separate cosmic miles.

Regarding rejuvenation/regeneration.

Kemp has clearly said before that they are not seeking to develop one approach fits all. Ricken is seeking that. So, that answers why they experimenting with DP cells only. In fact they are right. I can’t see people with just signs of balding paying 50.000$ for correction.

They are also looking into techniques similar to those of Ricken.

“ Work is continuing in this area to understand how to create new hair follicles and all groups, including HairClone, are realising that with human cells, 3D constructs containing dermal papilla and epithelial cells together is probably the way to go.”

As with regards to DP cells ability to migrate to the right place within follicle, I agree.

Therefore I would like to know how Replicell/Shiseido resolve that.


#11

The problem is that unless this is solved, EVERY method using DP cell cultures and injection of DP cells will fail. Unfortunately, even if the inductivity issue is solved using the technology you referred to, the issue of migration of the cells and attachment and integration of the cells into the follicle will remain, and no method using injections will work well enough to be commercialized. Even DP cells that are 100% inductive will not be able to help if they can’t migrate to the right place.

And that includes Shiseido and Replicel, too.

For people with just first signs of balding, they wouldn’t have to pay “$50,000”. Just like HT, the cost of the procedure will vary proportionately with the amount of hair they need to replace. So if they only need a small amount of hair, then the doctors would only need to create a small number of bioengineered follicles. Sure, there’s the extra lab costs on top of implantation, but those costs would also be reduced proportionately.


#12

“Even DP cells that are 100% inductive will not be able to help if they can’t migrate to the right place. “

Totally agree on this.

I do remember though Dr.R.Hoffman from Replicel in his interview mentioning that they had DS cells marked and found they migrated to where they were supposed to migrate during trials. I don’t know how significant or consistent that was but the reason that Shiseido’s “cure for hair loss” release is half-year overdue, makes me think they most likely ran into the same problems as Intercytex/Aderans.

In relation to newly balding people’s options. By the way things develop here, I think it’s more likely now scientists will sooner be able to manufacture brand new follicles for transplantation rather than any viable treatment to recover miniaturized hair follicles is found. So yes, in the foreseeable future such people might not have other option but to go with super invasive and expensive procedure like that of Tsuji/Ricken.

I think sooner or later science will master injectable option but it might not happen in our lifetime.

We need brand new follicles. Hair loss science needs brand new scientists to move forward.


#13

This is the same thing I’m thinking. And it’s really surprising that supposedly intelligent scientific researchers are basically trying the same technique that failed in previous attempts (Intercytex and Aderans) years ago. What is wrong with these scientists?

A lot of Regular Joes at hair websites comprehend that you need to use both cells, not just dp cells. Plus, many Regular Joes understand that you have to protect inducivity during mass pass culture. I don’t think Shiseido is taking either of these factors into account (using both cells + protecting inductivity in culture) so what makes the genius scientists at Shiseido think they’ll get any better results than Intercytex or Aderans did?

I don’t think we necessarily need new scientists. I just think the scientists we already have need to accept established facts. They won’t grow acceptable amounts of hair on humans until they find a way to use both cells and protect inductivity during culture.


#15

From the latest update by HairClone today 16 January

The business

  • Our crowdfunding campaign has now started in partnership with Capital Cell, (https://capitalcell.co.uk). This is an important aspect of HairClone’s strategy to develop a more inclusive Biotechnology Company with clinicians, scientists and patients collaborating together. The management of HairClone have considerable experience in raising VC and Angel funds for early and late stage Biotechnology Companies and this is still an option. However, the aim of the crowdfunding is to enable people from anywhere in the world to become HairClone shareholders and to help fund and accelerate the development of our treatments. Typically, early stage investing in companies such as HairClone is only available to “accredited” investors who meet certain financial criteria. Through the equity crowdfunding campaign with Capital Cell anyone can own a share of HairClone with the minimum investment of £100. Our goal is to raise £300,000 which will be used to launch the world’s first follicle banking service and to accelerate development of our “cell expansion service” that will allow clinicians to request cells for treatment of individual patients. At the moment, Capital Cell are just collecting pledges. When and if the target reached, then Capital Cell will arrange for the share purchase. All the shareholders would benefit as HairClone’s valuation increased and although we can not guarantee success, we are working to treat an extremely common and distressing disease. Currently the most successful treatment for hair loss is hair transplantation and patients spent $4.1 billion on hair transplantation in 2016. If we developed a treatment which provided even a fraction of this income, then HairClone would become a very valuable Company. Capital Cell have an extensive FAQ about crowdfunding on https://capitalcell.co.uk/faqs/ which we encourage anyone to visit before deciding whether or not to make an investment but we do hope that lots of people join us and help us to make hair loss history.

The science

  • We have now developed a follicle preservation system, which allows us to transport follicles around the world at refrigerated temperatures, then cryopreserve them, store them at temperatures below - 150C. Then when needed, we are able to thaw them, isolated the required follicle cells and culture (clone) them. We are submitting the scientific data in our HTA license application and expect to start the world’s first follicle bank soon.

  • Studies are continuing on comparing methods to expand (clone) hair follicle cells. We have a system in the laboratory that can go from a few hair follicles to a dose that could be used for treatment in 3-4 weeks. We are now working with a licensed cell culture facility to determine the requirements from the MHRA (The UK’s equivalent of the FDA) to enable HairClone to offer this Cell Expansion Service to our clinical partners. We expect to be able to offer this service around mid 2019 but will continue to carry out work in the laboratory to examine ways to improve and accelerate this cloning.

  • Our PhD student has been looking at which genes are active in DP cells from balding and non balding regions we are extending this work to look at how this difference persists when we culture these cells. This will be important when we look at the process of follicle rejuvenation as in order to understand how rejuvenation is working, we will need to differentiate between the “resident” DP cells of the miniaturising follicle and the cultured DP cells that the clinician injects. This will also provide us evidence that would support the concept that as well as rejuvenating a miniaturising hair follicle back to its original size it could also be converting what was a DHT sensitive follicle so that it doesn’t miniaturise on subsequent hair cycles.


#16

All true, but I’d also add the question about migration and attachment of the injected cells to the dermal papilla. Apparently Replicel is claiming they’ve marked injected DP cells and they’re showing up in the papilla, but I don’t think this is a given, and frankly, I don’t know how trustworthy their report is. It may be like 1 out of 1,000,000 injected DP cells are migrating to the proper spot, and they’re reporting this as positive results without giving us the full details (which are maybe much less positive)… just so they can spin their work as a success. I’m not accusing them of this, but we just don’t know. All we do know is that Replicel is taking much longer than imagined to complete their trials and approval process in Asia, which is very disturbing and doesn’t make them look too good.


#17

I agree 99%. The only thing I disagree with is that it’s not Replicel doing the Asian studies. It’s Shiseido. Other than that you’re right. We have no idea what’s taking so long but it does seem like they would be announcing something if the results were good. Keep in mind that Shiseido already spend a fortune (a fortune even by their standards) on a major facility, equipment, and other stuff so they can start marketing their RCH - 01 treatment so I can imagine that they would feel highly foolish if the results were bad. And if bad results made them feel very foolish I can imagine they would want to keep quiet about that. Nobody wants to stand up and take a hit when a project fails. Like they say, victory has a hundred fathers and defeat is an orphan. It looks to me like Shiseido is vanishing without a word when it comes to RCH - 01. I do not hear any champagne corks popping.


#21

@jarjarbinx Replicel is doing Asian studies too… and in fact they also have a contract with Shiseido to let Shiseido market their product in Asia. Although the partnership between the 2 companies is still in effect, Shiseido sued Replicel because Replicel hadn’t released research data to Shiseido as promised in the contract between the two (Replicel’s “excuse” for this was that there was a lack of funding). I think the result of that lawsuit was that Replicel will forfeit all revenues from the Asian market, they will all go to Shiseido.

As far as I know, Shiseido also has its own hair regeneration research program, that does not involve Replicel. That’s why the relationship between the 2 companies is so confusing.

The RCH-01 product is actually RepliCel’s, but they have to give all Asia revenues from that to Shiseido because they partially breached the contract… I think they are relying on potential revenues from N. America and Europe to keep their company afloat. See red section of this page -

https://replicel.com/products/rch-01


#22

Correct JarJar. It’s Shiseido and not Replicel that is running those trials in Japan. In fact technically Tokyo Medical University. Shiseido did not obtain product’s distribution rights. It acquired license to concept technology. Undeveloped technology, not ready for use. And if it’s ever going to come out with this, I’m afraid it will not be regarded as canadian or american. Sorry Donald. At least not in Japan.

Keep in mind that Shiseido already spend a fortune (a fortune even by their standards) on a major facility, equipment, and other stuff so they can start marketing their RCH - 01 treatment so I can imagine that they would feel highly foolish if the results were bad. And if bad results made them feel very foolish I can imagine they would want to keep quiet about that .”

JarJar, we don’t even know how much money Aderans invested 10 years ago into their program. Over 100 mln. Dollars. Back in 2012 they had over 15 trial sites at different locations across US. From west coast to East coast, from Wisconsin to Texas. And they did exactly that what you’ ve just sa id – they kept quiet until the last minute before they folded.


#23

@Otter There seems to be some confusion about what roles Shiseido and Replicel are playing. There are two completely separate projects using two different technologies. One is run by Shiseido exclusively, and the other is a joint venture by Replicel and Shiseido. Both are conducting the research in Japan. Maybe this summary from Folliclethought will help:

Shiseido/Replicel – Replicel’s hair growth treatment, RCH-01, involves culturing a person’s own hair follicle cells and then re-injecting them back into their scalp. First, a small punch-biopsy is removed from a person’s healthy hair follicles. Then, a specific cell is dissected from the follicle and cultured in a growth medium. The cells are replicated into the millions and then injected back into the person’s scalp. There is a short video about the procedure here. Replicel has been involved in a lot of activity over the past years to further develop their RCH-01 treatment into a worldwide success. For starters, Replicel created a partnership with Shiseido, which is the fourth largest cosmetic company in the world. In May 2014 Shiseido opened a huge biotechnology facility in Japan to accelerate the launch of Replicel’s hair technology RCH-01. This endeavor coincides perfectly with Japan’s new legislation which is designed to help expedite the trial process for stem cell technologies. In other words, Japan is an ideal place to launch a new cellular-based technology and get it to market quickly. To be clear, Shiseido and Replicel are separate companies. Replicel has licensed Shiseido the rights to bring RCH-01 to the world through an expedited regulatory path in Japan. It is worth mentioning that Shiseido also has its own scientists who are working on a separate hair regeneration technique using iPS cells. A treatment using iPS cells would be a further advancement and could potentially produce an unlimited amount of hair regrowth.
Points of Interest: Shiseido is currently trialing Replicel’s RCH-01 in Japan for market approval by the end of 2018. Replicel is also planning on launching its own RCH-01 phase 2 trial, estimated to take place in 2019-beyond, for the regulatory pathway in North America. Lee Buckler of Repicel has told Follicle Thought that he estimates an announcement coming from Shiseido in Sept/Oct 2018.
Status : Shiseido’s Japan trial launched in 3rd quarter 2016. Depending on the date of the trial’s completion, which has not been disclosed, the treatment could become available in 2019.