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Dr Rassman, Lately i have heard talk of the possiblity that WNT/regenerative treatments may lead to cancer. Could you please clarify this topic and offer any opinions? thank you

It seems like Wnt stimulated follicular neogenesis is hot area of biotech now (Histogen, Follica), but it is something that I do not understand enough to speak with authority. This is straight from Wikipedia, which is sourced from a July 2005 article in the scientific journal Nature: “The Wnt signaling pathway describes a complex network of proteins most well known for their roles in embryogenesis and cancer, but also involved in normal physiological processes in adult animals.”

I do not think I can clarify much more for you aside from what is stated. From the little research I’ve done, Wnt signaling has been associated with cancer in some tissues. How that relates to what they’re doing with hair, I haven’t a clue.

Hi there,

My question is, have you heard of ‘Hair Science International’? I went to see them last week here in Melbourne Australia and they say they can take a sample of my hair from the back and multiply up to 70,000 hairs in a lab and transplant however much I need back into my head and it will stay for ever. I’ve seen some of the results and in terms of coverage it’s great. But I don’t know how well this technology works in recreating the natural hairline and what kind of survival rate it averages.

Should I avoid them or is it worth investigating them more? Any advice would be much appreciated.

Thankyou.

Oh boy. What was that phrase that’s usually wrongly attributed to showman PT Barnum? Oh right… “There’s a sucker born every minute.” Regardless of who actually said it, it is probably a true statement.

If you were actually told these things, the hell with your hair, let’s buy the company and give Bill Gates a run for the richest man on Earth. I could go on all day with sarcasm, but if this company told you they could take a hair from the back of your head and multiply it to 70,000 hairs, then transplant it as needed (and their site says without surgery?)… then they’re either from the future or someone was giving you a line of bull.

My guess based on the photos on their site is that they sell fancy wigs and laser treatments. That’s the only way I could explain how they can call this “hair multiplication” but then in the same sentence say that it is non-surgical. Even then, they’re using “hair multiplication” in a completely misleading way. The technology doesn’t exist in the way you described. So either you misunderstood what they told you or they’re misrepresenting themselves. It’s not cloning or multiplication.

From the article:

Follica, the Boston-area startup out to bring a scientific approach to helping hair-loss sufferers re-grow their locks, is preparing for some new growth of its own. The firm, run since its late 2006 inception by founding CEO Daphne Zohar of Boston’s PureTech Ventures, announced today the hiring of a new president and CEO, William Ju, a biopharmaceutical veteran with experience in an array of therapeutic arenas, including dermatology (he is a board certified dermatologist). The selection of Ju seems to position the firm to move out of the purely research-focused stage and closer to becoming a drug development company.

Read the full text at Xconomy.com

We last heard some activity from the Follica folks last summer, when they got an extra $11 million round of funding in addition to the initial $5.5 million they received in early 2008. Now they’ve got a new CEO. What does it all mean? One could only speculate at this point…

Hello doctor,

I am a 28 yr old male. My hair drastically started reducing its density starting two years ago. It is true that you notice you are losing hair when you lose almost half of it. I now keep it shaved and when hair grows out you can tell very well that my hair is much thinner starting from the crown down to the top/front of my head.

I have gone through a substantial amount of literature regarding baldness (you have a very well informed website btw), and although I am very excited about the new age treatments like hair multiplication and cloning (endless supply of donor hair), I am quite aware that all this is at its inception with much more work to be done.

My question to you is this. Since you are a man of science, and you have witnessed it advance in the area of treating baldness since the last two decades, do you believe, taking all the current advancements into consideration, that there will be a breakthrough in 10-15 years? Of course, I know that you cannot be prophetic in the matter but simply what your thoughts are. Because your guess will certainly be better than mine.

I am optimistic of a hair loss breakthrough in 10 to 15 years, but if you asked someone a decade ago, they likely would’ve said the same thing back then. A lot of people are getting tired of hearing the same old “cure in the next 10 years” talk, but I will continue to be optimistic even if that timeframe comes and goes. Baldness isn’t a life threatening illness, but it is a billion dollar business… so as long as people continue to lose hair and there’s a market to end that loss, there will be companies clamoring to come up with the next great treatment. As technology evolves, the concepts that some people came up with that were once considered ludicrous can finally start to become within reality’s reach. Don’t get me wrong — there are still plenty of ridiculous ideas that will never work to treat hair loss. We’ll just have to wait and see and try not to buy into the hype too much, because there’s been far too many letdowns over the years (like that flying car we’ve all been promised).

With respect to the current gold standard in hair restoration technology, hair transplant procedures have come a long way in the last 10-15 years where most doctors are performing the individual hair follicle transplants or follicular unit transplants that give wonderful results with issues that are virtually undetectable.

Thank you very much for answering our questions and for having this site. Thank you Dr. Farjo for joining. These questions are for Dr. Farjo re: hair multiplication/intercytex study:

1. Is Intercytex going to phase 3 trials with the procedure they currently have?
2. Is the current product marketable given the current results, if it does go into phase 3? (It sounds like it is not, but that it created an enterance into another idea that may be marketable)
3. How long do you think it will be before a marketable product exists?
4. You mention that further studies are planned. When do you think this new Photo-hair technology will be tested on humans?
5. Will Intercytex be doing these studies? It sounds like they are waiting for someone else to buy them out. If not Intercytex, who will be doing these studies?
6. Intercytex has mentioned they have given Bosley the option of purchasing them or parterning. Bosley has their own theory on how to make this work, so why would Bosley buy them? (Speculating of course)
7. Who else besides Intercytex and Bosley/Aderans seems to be doing hair multiplication testing/research?

Thank you for any or all all answers to the above questions.

The following response is by UK-based physician Dr. Bessam Farjo:

Response by: Dr Bessam Farjo United Kingdom

1. A decision has not been made yet on timing. One reason is that we are still waiting on the analysis of the global photos concerning the larger of the injected areas. A second reason is the more promising finding of growing hairs out of the multiplied cells in the lab in the mouse, which will hopefully lead to a new clinical trial. Finally there are financial restrictions at the moment due to the global economic situation that is affecting most biotech companies.
2. See Q1. A product goes into market only after successful phase III.
3. Due to all what I mentioned it would be foolish of me to predict that with any accuracy.
4. A clinical trial should take place once the lab studies on human hair produce results reliably and predictably. We’re not at that point yet.
5. No, that is not the case. They said they are looking for funding from outside the company for this project. Given the funds, Intercytex will continue with these studies.
6. Bosley has an option to market Intercytex’s product should they succeed ahead of Bosley (or more accurately Aderans). I take this opportunity to confirm that I am neither a director nor a shareholder with Intercytex plc.
7. I am not aware of anyone else.

You’re very welcome.

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Learn more about the author of this article, Dr. Bessam Farjo, on his BaldingBlog profile or at his website.

Dr Rassman, What are your feelings concerning Aderans Phase II trial that is commencing this month?

I am sure I will hear more about it in detail at this year’s ISHRS conference in July. I will keep you posted, but I have no knowledge of the details in the approach that they are using.

I did find this press release they sent out to announce the start of their phase 2 clinical study. In the press release, it reveals that Phase 2 “is being conducted in six U.S. cities: Atlanta, Boston, New York, Raleigh, Houston, and Washington DC”… but that’s really the gist of it. I don’t know how many are in the trial or how long it’ll be going on for.

How would Hair Multiplication work? Not technology wise, but market placement wise. How much would it cost? I’m pretty sure they could charge whatever they want and it wouldn’t change the mind of too many potential customers you would think. So really it’s a question of of their ethical and moral standpoint I guess, but if you could give some sort of estimate I would really appreciate it. Also what would happen to the drugs market, I know drugs like Finasteride, Dutasteride and Minoxidil are used for other reasons but I have reason to believe that most of their money is made in the Hair loss market, I’m aware that most people who are in the early stages of MPB would continue to use these as you can still get a good 5+ years out of it, but people worried about side-effects and people who are on high income will just forgo the drugs and go straight into the HM procedure. Finally I wonder about hair transplant doctors such as yourselves, I know that they will be useful in performing the HM procedures but from the procedures described by Intercytex these would be of much less precision and skill, would this mean that HT doctors would have to take a huge wage fall? I think most of the money would be paid to the company which take the hair follicles and multiply them, so what is your opinion on this.

On another note, I asked a question recently about why hair follicles can’t be preserved and I now understand that they can not be preserved, so how is this going to work? they plan to take your hair and multiply and this process would take a few weeks, but surely all the hair would just die in that time?

I do not know the answers to your questions. I would assume that there will be training in whatever the technology evolves into, but as it is not final yet, there is no way to tell. Usually drug companies come out with the product and the process and doctors become qualified to use it.

Take Botox, for example… the doctor buys it from the manufacturer and then charges the patient for the medicine used and the service he provides with its use. I would imagine the same would occur with hair multiplication.

This is a continuation to last week’s post, Intercytex Announces ICX-TRC Phase 2 Results by Dr. Bessam Farjo. He had included these images with the text of his original article, but I didn’t have captions for them so I held them back until they could be presented in the proper context. The captions and images were provided by Dr. Farjo. Click to enlarge:

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Baseline MacroPhoto of tattooed study area 1 week after injections

 

MacroPhoto of tattooed study area prior to cell injections

 

Preparing multiplied cells in solution in GMP facility

Read more of “Images for “Intercytex Announces ICX-TRC Phase 2 Results””…

Release from Intercytex: PDF file

They still believe that this can be a marketable product, the question as an expert what do you make of this data? It does say that more data will be released later this year i’m presuming photos.

Our newest author on BaldingBlog, Dr. Bessam Farjo, is intimately familiar with Intercytex. The following response comes from him:

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Response by: Dr Bessam Farjo United Kingdom

We finished following up the last volunteer of Phase II of the trial about 6 weeks ago, and the 1st set of analysis data have just been released. This trial was designed to examine the effect of different dermal papilla (the hair producing cells in the root) delivery techniques and methods to ensure that the epidermal (superficial skin layer) cells were in the correct state to respond to the signals and produce new hairs.

To recap, the point of the trial is to see if it is possible to create a limitless supply of donor hair and deliver results with very minimum of surgery. In each subject, an initial surgical harvest of around 100 hairs roots was performed, dermal papilla cells separated and then put in a proprietary culture medium for 8 weeks. In this medium the cells multiply extensively producing millions of ‘cloned’ DP cells.

Each volunteer was injected 900 times with the suspension containing the lab-grown DP cells in a large area which was photographed at the end of the study. Volunteers were also injected in a smaller area, divided into two halves - counts were obtained by shaving and photographing the two small halves of this small area of the scalp, injecting them multiple times (either 1 injection of 50 µl or 50 injections of 1 µl) with living DP cell suspension and then applying a specialized image analysis system to provide a total hair count. In these small sections, all 19 subjects in the trial were treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 subjects the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells in one of the two treatment sites. 13 subjects completed the 48-week trial with 6 subjects lost to follow-up. Of the 13 subjects completing the trial the data showed that:

• 65% (11/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs of all sizes
• 71% (12/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs over 30 microns in diameter
• 78% (7/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs of all sizes
• 100% (9/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs over 30 micron in diameter
• The overall take rate (number of hairs produced per 100 injections) in the stimulated areas was
  • 40% (n=6) for hairs of all sizes
  • 18% (n=6) for hairs over 30 microns in diameter

The larger (900 injection) area photographs have not yet been analysed. As a reference, hairs under 30 microns in diameter that grow less than 1 cm in length are vellus baby-like hairs, while terminal adult-like hairs are more than 30 microns in diameter and grow more than 1cm in length.

The data strongly suggests that new hair production is improved by pre-stimulation of the scalp. This is essentially a technique to cause a minor injury to the skin surface, leading to an interaction between the injected cells and the resident hair producing cells. The role of an injury or skin wound in hair growth in mice had first been established a year or two ago by Cotsarelis and his team.

From a clinical point of view, what we have learned is that when such a technique becomes an available commercial treatment, it can be a rapid and pain free procedure. Obviously local anesthetic will be used, but certainly 1000 injections can be performed in under an hour with post op pain almost non existent and scabbing very minimal.

Further studies are of course planned, but one exciting area that may point to the way of the future is the development of the so-called Proto-Hairs. Still in the lab stage for now, animal multiplied dermal papilla cells are developing terminal hairs in the lab dish. Once this is duplicated reliably in the human model and proved to work in a human trial, it may provide another alternative to the concept of cell therapy for hair loss.

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Learn more about the author of this article, Dr. Bessam Farjo, on his BaldingBlog profile or at his website.

What are the real chances of any of these “baldness cures” becoming a reality, I mean REAL no BS to make us feel better. Things like TRX2 and Aderans, when do you really think we will, if at all, see these on the market?

Probably not… but I am hopeful. To elaborate, we are at the infancy of genetic engineering and cloning. We are still striving to find the cure for the common cold, diabetes, cancer, HIV, etc. I think the cure for hair loss is not on the top of the list of what scientists puts their priorities on.

There have been some recent announcements, including the ReGenica press release, that may be worth looking at.