Brief Items of Interest, September 2016

Few days later than usual, but lots of new developments in the past month.

Hair loss news first:

— The most important news is courtesy of HLT, which several days ago interviewed people from the Dr. Tsuji/RIKEN/Organ Technologies team (but not Dr. Tsuji himself). Interview publication has been delayed due to Japan’s “Respect for the Aged Day“, but according to the HLT admin, he has been given permission to divulge the following regarding the Tsuji team’s work:

“Human trials to begin 2018. Commercial availability still on track for 2020.”

While not surprising since this is an affirmation of what was said in July of this year, it will hopefully put many people’s minds at ease…at least till early next year:-)

— Thanks to who else but JAK superfan “nasa_rs” for letting us know that Aclaris Therapeutics updated its pipeline page and finally added its topical JAK inhibitor product (ATI-500003) for men with androgenetic alopecia (AGA).  Interestingly, all four of its JAK products are now shown to be 80 percent or so through the pre-clinical phase and are on the verge of entering Phase 1 trials. According to the pdf from the company’s September 14th webcast (see page 26), proof-of-concept (POC = Phase 1 and Phase IIA) trials for the company’s alopecia areata (AA) drugs will commence in the first and second quarter of 2017.  Considering that JAK inhibitors Ruxolitinib and Tofacitinib have already been FDA approved and in use for around 5-6 years, the big question is whether this will allow faster progression of Phase 1 clinical trials for Aclaris’ various JAK products?  According to wikipedia, there are currently seven other JAK inhibitors in clinical trials.

— Long-time perpetual disappointment Follica, which had earlier announced initiation of a registration study in the second half of 2016 has delayed plans till the first half of 2017 (thanks as always to “Mike G”, who sent me that link and has e-mailed me news about Follica many times in the past).  A recently announced best-case product release scenario of 2018 by Follica now sounds just as unlikely as hyper-prolific commentator “mjones” ever meeting with his hero and Follica founder Dr. George Cotsarelis:-(

— In my June “brief items of interest” blog post, I mentioned that Allergan had commenced phase 2A clinical trials for Setipiprant to treat androgenetic alopecia.  The company updated its clinical trial page again in August and many of their centers in the US are currently recruiting volunteers.  It seems like they will even pay you up to $650 for participating.

— Allergan also updated its Bimatoprost clinical trial page in August.  Study is expected to be completed very soon in October 2016.

Follicum updated its website regarding  the second part of their clinical phase I/IIa study for their FOL-005 hair loss product.  I like the fact that they are undertaking some of this work at the reputable Charité-Universitätsmedizin Berlin in Germany.  Follicum also sent out an e-mail to many people (one of whom was myself) and here is the gist of it:

“The study is divided in two parts, a single ascending dose part and a multiple dose part.  Multiple dosing has begun on healthy volunteers.  The study has now finalized recruiting volunteers and is fully recruited, it is being carried out in Germany at: Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin, Germany.  As this is a regulated clinical trial results have to be published once the trial is completed and all the results have been analysed, which is estimated to be in January 2017.”

A conference on the Wnt signaling pathway ran from 14th-17th September in the Czech Republic.  Interestingly, Samumed was one of the main sponsors.  Of even more importance, it seems like Samumed made an extremely interesting and well received presentation at the 13th Medical Innovation Summit in London on September 17th 2016.  Why do I say that without seeing the actual presentation?  Because of numerous Tweets praising it…see this blog’s recent Twitter feed and thanks to commentator “Optimism” who notified me of the Twitter praise for Samumed’s presentation.

— Commentator “richieron” mentioned something about this Brotzu lotion group buy from an Italian blogger (I linked to that same blog in my July “brief items of interest” post).  Read this for more on Dr. Brotzu.  I cannot recommend buying from strangers on the internet, but nevertheless, interesting to follow.

— The Follicle Thought blog had an extensive interview with HairCell CEO Howard Leonhardt.

— One of the commentators on this forum named “skin” has created a thread on his dermarolling treatment on the Bald Truth forums. He made some interesting comments in this old post of mine that are worth reading, especially if you are considering trying out dermarolling.

Lengthy article on hair loss, including some thoughts from Dr. Claire Higgins.

— Yet another study on the genetics behind hair loss.

Scalp micropigmentation video on Quartz.

Troy Hurtubise wants to cure hair loss.  This is about as far fetched as it will ever get in our already way-out-there hair loss cure world.

— Donald Trump lets Jimmy Fallon mess up his hair:

And now on to medical items of interest:

— Burned firefighter Pat Hardison continues to thrive one year after his face transplant.  Pretty amazing progression via monthly images in here.

— MIT scientist claims that his pill is the one when it comes to the fountain of youth.  Most important (and discouraging for us) quote:

“Guarente has been taking Basis for two years, but it’s a good bet that he is not among those who have observed hair growth as one of the pill’s effects.” 

— World’s formerly fattest man who lost 658 pound after gastric bypass surgery in 2010 will now get a second free surgery to remove excess skin.

— OxSyBio’s 3D “droplet printing” technology creates a tissue-like material that functions just like real cells.

— Embryos from skin cells instead of from eggs?  And of course artificial wombs. Would mean real freedom for both men and women.

Infertile mice give birth due to 3D printed ovaries.

Stem cell therapy restores arm and hand movement for a paralyzed man.

New drug to treat Alzheimer’s could be very effective.

—  Lysyl oxidase inhibition could eliminate scar formation.

Cold plasma to heal wounds.

— CRISPR’d vegetables are now here.

— With Japanese electronics behemoth Kyocera partnering with Tsuji/RIKEN and their cell based work, it is perhaps not surprising that in the US General Electric now aims to build a $1 billion business “offering vital manufacturing tools for a coming wave of cell therapies.

Manufacturing dopamine in the brain with gene therapy.

Dramatic advances in human-on-a-chip technology will likely lead to a significant reduction in animal testing.  As it is, we in the hair loss world have seen almost zero benefit from many decades of research on mice.  These chips are going to be a much better approximation of real human beings in comparison to mice it seems.

Wharton’s Jelly Derived Mesenchymal Stem Cells and Hair Follicle Generation

Update:  I e-mailed Dr. Omar Aljitawi to ask him two questions (thanks to commentator “Jayjayaustria” for the first one) about this posts’s subject matter.  Then I sent him a second e-mail for further clarification.  Below are Dr. Aljitawi’s responses:

E-mail 1:

Admin: Since most people in the world have not saved their umbilical cord at birth, how would they benefit from this technology? Would you extract their stem cells from the Wharton’s jelly found in the eyeball region?

Dr. Aljitawi: I have not looked into other mesenchymal stem cell sources. For those who do not have their own umbilical cord MSCs saved, it might be possible to use third party MSCs.

Admin: Is there any reason that this technology has not proceeded any further insofar as getting to clinical trials? Are you actively looking for funding?

Dr. Aljitawi: Funding is certainly one obstacle. Finding expertise in the area to collaborate with is another obstacle. I am working on these obstacles now and I am very optimistic that we can move things forward faster, hopefully soon.

E-mail 2:

Admin: If you do use third party MSCs, is there a chance of rejection? Is it similar to using someone else’s organ during an organ transplant and than taking organ rejection medications for life?

Dr. Aljitawi: It remains a concern. However, the hair follicle is immune privileged, so that might not be an issue.


Umbilical Cord Wharton’s Jelly Superior to Umbilical Cord Blood

In my last post I mentioned the potential importance of storing cord blood (which is a sample of blood taken from a newborn baby’s umbilical cord).  In a surprising coincidence, today I read a highly interesting new study summary pertaining to umbilical cord derived Wharton’s jelly mesenchymal stem cells (WJMSCs) and hair follicle regeneration.

Wharton’s jelly is a gelatinous substance within the umbilical cord (as well as in the eyeball region).  Typically, mesenchymal stem cells (MSCs) are derived from 1) Wharton’s jelly of the umbilical cord or from 2) umbilical cord blood.  However, there is a much higher concentration of MSCs in Wharton’s jelly in comparison to cord blood

Ectodermal Differentiation of WJMSCs and Hair Follicle Generation

In this latest study, the authors show the mechanisms underlying ectodermal differentiation of WJMSCs.  It should be noted that in 2013, two of the co-authors (Aljitawi OS and Hopkins RA) of this latest 2016 study first showed that they could generate cytokeratin 19-positive cells and hair-like structures from WJMSCs in vitro.  They summarized their results from 2013 as follows:

In one method, WJMSCs were seeded on a matrix isolated from Wharton’s jelly following decellularization. In the other method, WJMSCs were cultured to form spheroids. Our findings demonstrate that WJMSCs may have the capacity for ectodermal differentiation.

I have discussed 3D culturing and 3D spheroids many times on this blog in the past, and that subject is of foremost importance when it comes to hair cloning.  For the scientists among this blog’s readership, the patent for this technology has some detailed information on the spheroid technology being used (especially in sections 0065 through 0067).

Two of the latest 2016 study’s authors (Jadalannagari S and Aljitawi OS) also authored yet another paper in 2015 outlining the potential application of WJMSCs for tissue engineering and regenerative medicine applications.

Finally, in this latest 2016 study the authors also note that “up-regulation of β-catenin and noggin, along with the expression of TGF-β and SMAD and inhibition of BMP4 could be the mechanism behind this ectodermal differentiation and hair-like structure formation.”

University of Kansas Innovation and Collaboration (KUIC) Patent and Licensing Options?

The main author of the above studies is Dr. Omar Aljitawi who is currently a professor at the University of Kansas Medical Center. According to his bio “Dr. Aljitawi also has been studying Wharton’s jelly matrix as a scaffolding material for tissue regenerative applications like bone and cartilage regeneration.”  However, of much more importance is the fact that when it comes to hair regeneration, this technology might be for licensing or sale?!  I say this because of this page on the University of Kansas Innovation and Collaboration (KUIC)’s website.   Most relevant sentences/quotes on that page:

Application: Restore hair and treat baldness.

Benefits: The method can be used for restoring hair, which can potentially solve the problem of baldness.

Why it is Better: Current technology simply isolates cells from pre-existing hair shafts. This new method derives mesenchymal
stem cells from Wharton’s jelly matrix and stimulates them to produce hair follicle cells and hair structure. Hair
can be restored and baldness can be treated.

The inventors of this technology are listed as the earlier mentioned Dr. Omar Aljitawi along with a Dr. Lynda Bonewald (who seems mostly interested in bones and not hair).  The actual patent titled “Generating ck19-positive cells with hair-like structures from Wharton’s jelly” does not have Ms. Bonewald’s name on it.

The “licensing associate” for this technology is Dr. Aswini Betha.  I am curious why companies are not approaching him or the University of Kansas to acquire this technology considering that the patent was filed in 2013 and approved in 2014?  Perhaps Mr. Neal Walker would be interested?

The University of Kansas has now been added to the list of important hair loss cure research centers around the world.

Edit: There is also another 2014 study from India that suggests that human Wharton’s jelly mesenchymal stem cells promote scar-free skin wound healing with hair growth.

HairClone (aka hairclone.me)

During the past few months, there have been a few new companies entering the hair regeneration sector, but none have impressed me and I have limited my coverage of all those companies to small sections within my once a month “brief items of interest” posts. Today, I learnt about yet another new entrant into the field named HairClone that I felt finally warranted its own post (albeit barely). I still have some serious doubts about this company (would be shocked if they come out with anything substantial in the next 5 years) and do not consider them anywhere near as important to us as the established entities such as the RIKEN/Kyocera/Tsuji partnership (Japan) or the Shiseido/ Replicel partnership (Japan). Before I continue, I have to give credit to the FollicleThought  blog for covering this news first and also to several of this blog’s readers who e-mailed me about it or wrote a comment about it in the last post.  I will briefly analyze this new company via positives and negatives:

Positives

  • The renowned and widely respected researcher Dr. Claire Higgins joined HairClone’s advisory board on August 30th (but alse read my comment on her in the “Negatives” section below).

  • HairClone will be hiring more scientific advisers besides Dr. Claire Higgins in the near future.  Would be great if they tried to get Dr. Roland Lauster into the team.
  • A recent Tweet suggests monthly update meetings with PhD students:

  • HairClone has devised a very unique and creative way to get funding (not necessarily a positive in many people’s minds) and that includes: crowdfunding; giving people who fund the company’s research preference when the actual treatment comes out; allowing investment in equity; offering leading hair transplant clinics around the world membership opportunities; and most interesting of all, hair follicle banking and storage.  On a somewhat related note, if you are having a baby, consider cord blood storage if you have the financial wherewithal.

Negatives

  • By far the biggest negative is that this is still way too early in the game and who knows when trials will commence, and whether the company will succeed with its dermal papilla focused cloning technology in the first place.  Or even if they manage to get sufficient funding.
  • Related to the above, when Solomon interviewed Dr. Claire Higgins earlier this year, she generally sounded pessimistic about new treatments and said the following about cloning (Update: Solomon corrected me in the comments and said she was only talking about cell injections here….but I think in general she sounded pessimistic about the hair cloning time frame in the whole interview):

“I think the future (but it’s not in 4 years or 5 years away, it’s like in 20 years) is to promote direct conversion of fibroblasts into papillae. But something like this will take decades. We don’t know how to do that yet.”

I am hoping that Dr Higgins will change her prediction to 10 years if her lab (only two years old at the time of the interview) and research work gets significantly more resources as a result of HairClone. Thankfully she said that she was not exactly sure about Dr. Tsuji’s work and neither did she list Shiseido’s trials in Japan in her list of ongoing trial examples, so maybe she is just entirely focused on her own work and not following others too much.  20 years would be too big a gamble to invest in a company such as HairClone, and I hope Dr. Bessam Farjo has other ideas and is hoping for much faster completion of clinical trials.  And of course he is probably not just relying on Dr. Higgins’ dermal papilla related work.

  • The company website has some typos, flow issues and seems somewhat haphazardly put together at the moment.  e.g., this page that should probably be removed and this page’s URL includes “hello-world” like in an intro to computer science programming assignment etc…

A Hair Loss Blog