Kelopesia Update, Brotzu Trial, Cures: Weekly Thoughts 12/16/16

Hey everybody, welcome to another edition of Weekly Thoughts. This week I touch on two topicals that have been at the forefront of the attention of hair growth enthusiasts this past year. Also, I take a look at an intriguing healthcare legislation that was just passed in the United States this week.

Kelopesia Update

Remember when Kelopesia burst onto the scene earlier this year? Man, that was a hoot. It was slated as a new stem cell-conditioned media cream which would be available by the end of April in Turkey. Well, turns out that was not the way it happened. We’re not quite sure what lead to the delay, but that’s not really important anymore. What’s important is that we are actually close to the re-scheduled release date of Kelopesia. This past week I decided it was a good time to get an update from Yeditepe University.

Prof. Fikrettin Sahin, the gentleman and scholar who developed the Kelopesia cream, told me this week that his team is “working hard” to get Kelopesia released to the Turkish market in Spring 2017 and “hopefully” it will be released in January. There you have it.

Yes, he does mention that the release will be for the “Turkish” market. What does that mean for the rest of the world? It does mean that it will take more time for the product to be officially released in the rest of the world. However, it does not mean that the cream will be impossible to get if you do not live in Turkey. You can always visit Turkey or find other options on the internet.

Brotzu Lotion Trialing

It is only right that if we got news about Kelopesia we should hear more about the other top-notch topical making waves in the hairternet. I heard from a representative at Fidia Pharma that the famed Brotzu Lotion is still undergoing a clinical trial with the company and therefore a release date is not certain yet. 

My own personal take is that things should be winding up in the trial soon. The lotion seems to have been in a clinical trial for a good amount of time now; the trial was reported to begin last March. Personally, I have a good feeling about it, I do feel that this product is going to be released by Fidia at some point. For now, the release date is unknown.

America Accelerates Cures

This past week US President Barack Obama signed the 21st Cures Act into law. The bill is referred to as “Cures” and is heralded to advance the discovery, development, and delivery of drugs and therapies in the US market. It will do this by providing major funding to the National Institute of Health over the next several years, modernizing clinical trials, and utilizing health records and patient data in new ways to promote research collaboration. If you do a little internet research on the subject you will find some differing opinions on the impact of Cures among the healthcare industry, but whose really got time for that? 

Readers of this blog pretty much want to know one thing — how does Cures affect hair growth treatment development?  The answer is no one really knows yet. Experts in the regenerative medicine industry are still reviewing this huge piece of legislation to understand it better. Also, the way the bill is written leaves room for variables in how the FDA will actually utilize Cures.

Here’s what we do know about Cures for now:

  • Regerative medicine products, including stem cell therapies, can be granted “accelerated approval” by the FDA
  • Accelerated approval does allow a treatment to be available to patients before completing a phase III trial
  • Accelerated approval is typically intended for medical conditions with unmet needs

The questions of whether hair growth treatments will be allowed to utilize accelerated approval and exactly how all of this will work are unanswered at this point. To be honest though, it’s really nothing to lose sleep over. Treatments will go through the process anyways, if Cures provides some expediency to that, then very good. We’ve got to keep pushing forward, regardless. Time will tell how the FDA intends to utilize the new provisions of the 21st Century Cures Act. I recommend these three articles for more background: STAT, Wired, and TheHill. If there are any scientists or industry persons reading this that can offer some insight on the Cures Act please comment below. 

It has been a good year everybody and unless something major pops up in the next two weeks, I’ll speak to you all in 2017. Have a Happy New Year 🙂

New Brotzu Interview, Donor Regeneration Technology: Weekly Thoughts 6/24/16

Hello everyone and welcome to another edition of Weekly Thoughts.

We’re now past the halfway point of the year, and quite frankly, I think a lot of people expected there to be more news regarding pivotal clinical trails for some of our favorite hair growth technologies. Nonetheless, the good news continues to pour in and I have a feeling there will be some more major announcements soon. Let’s take a look at some meaningful hair growth treatment news as of recent.

New Dr Brotzu Interview

Dr Giovanni Brotzu completed a new interview for the BelliCapelli forum (Italian) yesterday and it is a great read. Having been a vascular surgeon for many decades Dr Brotzu has a wonderful understanding of the vascular system and it’s implications on alopecia. In the interview Brotzu mentions that there is currently an ongoing trial of 60 people with AGA using the lotion (probably Fidia’s trial),  and that he is personally conducting a trial of 18 people with alopecia areata/totalis. There is an excellent description of how the “Brotzu lotion” works in the interview with depictions included. Here’s a quote from one of Dr Brotzu’s responses to wet the appetite:

The lotion works very well when it begins to manifest alopecia, in people under the age of 30 will have good results with total stop of the fall and re-growth of hair and miniaturized hairs or even vellus / invisible resume a normal appearance. Logically, the treatment starts to give clear results after about 30 days and must be prolonged for many months. Continue reading

Brotzu Update: Alopecia Areata Presentation

I wanted to give everyone a quick update about one of the hottest topics in the hair growth treatment world, the Brotzu lotion. The information given during the presentation is mostly a rehash of what has been previously discussed, but does contain a few interesting tidbits including a few slides displaying hair follicle generation and a before/after photo of a baby who used the lotion.

Dr. Giovanni (John) Brotzu made a presentation last weekend at an Italian Alopecia Areata Association meeting. The presentation is completely in Italian, but is somewhat entertaining for non-Italian speakers like myself (Avanti!). Dr Brotzu was at the meeting to discuss his hair growth lotion discovery and also showed one photographic example of a baby with alopecia areata who used the treatment and has some nice hair growing about one year later (see below.) This treatment has very high credibility in my opinion. I really look forward to the pharmaceutical company producing the lotion (Fidia) releasing more information about their initial trial for the Brotzu lotion.BrotzuAA Continue reading

2017: A Look Ahead

I’ve got a good feeling about 2017…

For the past several years we have been pacified by the news of a research study or startup company working on a treatment that grows hair. Ultimately, we would prefer the treatment in our hands, but reading about it on a computer screen has been supportive as well. It’s something we can think of throughout the day or in a quiet moment which helps to release a little more serotonin in the brain. However, the time has to come for a treatment to be made available for us all and I believe that 2017 is going to be that year. This will mostly take place in the cosmetic market, but the treatments should be worthwhile.

For Starters…

  • You knew it was coming on this list. The acclaimed, enigmatic, and exceptionally Italian: Brotzu Lotion. As of January 2017, the product is reportedly still in clinical trial. Once the trial is finished Fidia Pharma will decide how to move forward with the product. There are tons of reasons to believe that this product will be a great success as far as cosmetic treatments go. One question that supports that belief is: how many products/research studies have been acquired by pharmaceutical companies and put through human trials in the past 10 years? If you’re new to the subject you may read more on the back story of the Brotzu Lotion by reviewing these articles.
    *Update* Fidia Pharma has finally released an official communication on their website about the Brotzu Lotion. The news was a bit of a curveball. Fidia has targeted 2018 as a release date for this lotion. While this is unexpected news (many thought the lotion would be available in 2017) the fact that this product exists in the first place is still reason for cheer.
  • Turkish Delight. The stem-cell derived cosmetic cream which was actually slated to be released last year at this time: Kelopesia. The research done to create this product was done at Yeditepe University and was lead by Dr. Fikrettin Sahin. And yes, this is the cream that involves using cellular derivatives from newborn foreskins. Why is that, might you ask? Well, the cells that are extracted from the newborn foreskins are still at a stage where they are very potent for growth and tissue generation. Let’s just leave it at that for now (laughs) and celebrate this potential breakthrough. This product should be released in Turkey within the first Q2017. Keep your eyes peeled on Ebay.
  • As of now Kelopesia is set for release in 2017. However, there is always the possibility for one of these

    The Wild Cards of 2017

    ‘Wild cards’ are products that emerge all of the sudden, show good promise, and are said to be made available shortly after their announcement. Stay tuned everyone 🙂

Clinical Players

2017 will be a great year for hair growth cosmetic products. On the clinical side of things, it is somewhat of an ‘in-betweener’ year. Most of the highly anticipated therapies, including Shiseido and Tsuji/Organ Technologies will still be in a trial process or R&D phase all the way through 2017. However, we will be getting trial results from many treatments. The trial results do give us valuable information about how the treatments are shaping up and they are necessary for the treatments to move forward. Here’s the most significant clinical trials for hair growth that will be taking place in 2017:

  • I was surprised to see them in this spot myself, but here they are. Follica is set to begin a phase III clinical trial in 2017. Or, maybe they already have begun this trial. Follica is kind of like the Carmen Sandiego of hair growth companies so no one really knows except for them. We know the phase III trial will happen in 2017. Pending results, this trial can lead to FDA approval for Follica. If all goes well Follica is aiming to put their micro wounding + compounds treatment for hair growth on the market in 2018. The treatment is now being titled as “RAIN” according to PureTech’s pipeline page. Does anyone know what the acronym stands for yet? My guess is “rejuvenate and induce neogenesis.”
  • Its electric. HairCell, the surprising company that was incepted by Howard Leonhardt in 2016 will be initiating its human pilot study in early 2017. The treatment involves wearing a bioelectric device on your head with stimulators that send signals to the cells of your body to repair and regenerate itself. This cap is also coupled with a micro-pump containing electro-acupuncture needles that inject stem cells/growth factors into the scalp. The entire concept is highly unique and advanced and I am a big fan. I look forward to hearing more about this human pilot study.
  • Getting set. Results from the setipiprant phase IIA trial. More hair follicle research stemming from the work of Dr. George Cotsarelis, setipiprant is an oral medication that is intended to halt hair loss and thicken existing hair. The drug is a protaglandin D2 receptor antagonist and was originally developed for inflammatory conditions such as asthma. However, when Dr. Cotsarelis found that the PDG2 receptor plays a significant role in hair growth, he patented that use and suddenly PDG2r drugs that were shelved became useful again. Kythera Biophrama decided to take a crack at it and licensed the use of setipiprant to treat hair loss. Because of the drug’s previous clinical trial involvement Kythera was allowed to start setipiprant at a phase IIa trial for androgenic alopecia. Since the time Kythera began this development of setipiprant their company was acquired by Allergan. This trial is set to complete in September 2017 and will compare results from setipiprant alongside finasteride to gauge its effectiveness. I find that comparison interesting.
  • The dynamic duo. Allergan is also anticipating the phase I results of their new and improved bimatoprost formula for the scalp. Bimatoprost was originally developed for glaucoma and later used to enhance eyelash growth. If it can grow eyelashes then it can probably grow hair, right? Right. Apparently, the bimatoprost scalp formula has recently been enhanced to promote even greater hair growth and hence they have begun another phase I trial. This trial should bear results sometime after October 2017.
  • Just maybe. Last year it seemed likely that right about now Histogen would be gearing up for a 2017 market release for its Hair Stimulating Complex in Mexico. As of late the company has been quiet about the potential of releasing HSC in Mexico. The HSC treatment still needs to go through a phase III trial for approval in Mexico, and if Histogen were to release the product in 2017 that trial would have begin very shortly. We know Histogen made some notable business developments in China in the 2nd half of 2016, if they will do the same in Mexico still remains to be seen. Veremos.
  • River of Hope. RiverTown Therapeutics Inc. is hoping to push forward with their phase 1B/2A this year. Getting the trial in place only depends on the company raising the necessary funds to finance the trial. RT1640 is RiverTown’s lead candidate for hair regeneration. The drug is composed of three agents: minoxidil, cyclosporine A, and a novel molecule called RT175. The RT175 molecule is said to promote the growth and migration of stem cells to the hair follicle, which multiplies the effects of both minoxidil and cyclosporine A, resulting in hair follicle regeneration. The company has previously shared some impressive photographs on Follicle Thought, displaying what RT1640 is capable of. Keep in mind these results came from a very small number of subjects who used the treatment for a short period of time. The potential is big here. Let’s see something great develop for RT in 2017.
  • A clone like no other. HairClone of the UK is taking a unique approach to get a next generation hair growth treatment to market. They are marketing the treatment to work in conjunction with hair transplants, they are utilizing crowd funding, and they are taking advantage of an innovative opportunity to get this treatment to patients very quickly. The most important factor here is that through a special medical designation in the UK known as “Specials” HairClone will be able to make their treatment available to patients prior to going through a clinical trial process. Under the guidelines of Specials a doctor in the UK will have the discretion to prescribe a treatment like HairClone for an unmet medical need; in this case it would be hair loss. If HairClone secures the funding to move things forward they can begin administering cellular treatments to patients in the year 2017!

New Players

One of the greatest things about turning a new year: the announcement of new companies. Last year was fruitful in this category and I expect 2017 to be even more exciting. Most of the new companies that we will see emerge in 2017 will come from names that we are familiar with. Here’s what to look for on the horizon in 2017:

  • Rapunzel. You’ve heard it mentioned here before. Rapunzel is the latest startup company of Angela Christiano which seeks to bring an injectable cellular treatment (using 3D cultured cells) to the clinical setting. Anyone who spends a bit of time reading up on hair follicle research knows that Angela Christiano is about the biggest name in the hair research industry. She has studied gene therapy, JAK inhibitors, cell culturing, and other areas of hair biology. The only other researcher who has probably spent more time studying the 3D culturing of hair cells would be Dr Colin Jahoda. And oh, guess what? Colin Jahoda is teaming up with Christiano for Rapunzel. Booya.
  • Tissuse. The German biotech company which is a spinout of the Technical University of Berlin is finally moving forward with its hair follicle multiplication work. This is evident from Tissuse’s recently updated website displaying a page for “Smart Hair Transplants.” The entire treatment process of SHT is not yet described on their website, though it does mention ‘extracting 30 hair follicles (via FUE) from the donor scalp to create 10,000 neopapillae (baby hair follicles).’ This just sounds incredible to hear, my imagination runs wild with possibilities. Man, is it just me or is this hair industry getting so big it’s not that easy to remember all of them now? It’s certainly a welcomed situation that we are at.

Let me thank you all for your support and being readers of the site. It is great to hear positive feedback from those of you who take a moment to share a few words on the site. As you can see, the hair growth treatment landscape is really turning into something that we all hoped it would for so long. Here’s to an amazing 2017 and hair growth success for the world. Cheers

2016: A Year in Review

It does not feel that long ago when I was writing the article 2016: A Look Ahead, but just like that here I am bringing a recap of a rather exciting year in the hair growth industry.

To start, let’s review what I highlighted in the original “2016 look ahead” post.

  • Samumed’s Phase II results – The results did not actually blow the door off the hinges, however they were positive. This treatment grows hair. Since the time that the initial phase II results were announced, Samumed has also completed another phase II trial which involved taking a biopsy of the scalp to observe how the drug was working in the tissue. So where does that leave everything now? Well, Samumed has a decision to make. That decision is whether they believe this treatment is worth going into a phase III trial for commercial approval. Hopefully the biopsy study has given them some insight as to how to improve the efficacy of their compound.
  • Shiseido Trial in Japan – The big announcement finally showed this past July. Shiseido received approval by the regulatory authorities of Japan to initiate their trial of RCH-01. The trials are being done at the Tokyo Medical University Hospital and Toho University Ohasi Medical Center. We look forward to hearing about these results in 2017.
  • Histogen Trial – We did not get any official word about Histogen initiating a trial this year, though they did make several business transactions to help further the development of their HSC product. Now, both China and Mexico are potential landing spots for HSC commercialization.
  • Follicum Phase I Trial – The first half of Follicum’s phase I/IIa began back in January, with the second half commencing in September. Follicum recently announced that the phase I/IIa study will be completed in January 2017. Follicum’s lead drug candidate, FOL-005, is interesting in the fact that it has the ability to both stimulate hair growth as well as inhibit hair growth. Jan Allenfall of Follicum mentioned in a press release that he believes the initial clinical trial of FOL-005 would produce hair inhibition. I’m sure that this crowd is more interested in the hair stimulation bit. Nonetheless, I believe Follicum has a savvy plan moving forward and we hope to hear about the results of this peptide getting hair to sprout.
  • Dermal Papilla Cell Culturing Trial – This long-lived and mysterious trial is set to finally be completed next month. There has been no word on whether the results will be released, but rest assured if they are I will give you all an update. The methods involved in this trial were derived from the research of Dr. Colin Jahoda, hair follicle Jedi master. Word on the street is that he is looking to get his work into the clinical setting soon and I will have more on that in the upcoming “2017 look ahead” post.
  • The Wildcard – In the original “look ahead” counterpart to this post I created a category for those discoveries that seem to come out of nowhere and surprise us (delight us). It’s good to leave room for something along the lines of a miracle to happen in the hair growth industry world. The announcement of a cosmetic topical that “produces legitimate hair growth and will be out on the market by the end of July”, or something to that effect. Well, in 2016 we had a flash of just that, a wildcard. It came be to known as the “Brotzu lotion.” The Brotzu lotion is currently being trialed in Italy as a cosmetic and it is likely that that trial should be winding up soon. I will update on it’s progress as soon as information becomes available. I have a feeling 2017 will be another fortunate year for wildcards. Stay tuned.

2016 was really a good year for us all. Some other excellent accomplishments were:

  • Aclaris Therapeutics acquired JAK inhibitor IP to be trialed for use in AGA.
  • RiverTown Therpeutic’s wonder drug RT1640 was announced to regenerate and restore pigment to follicles.
  • Tsuji/Organ Technologies announced they will embark on a revolutionary hair growth venture aimed at a 2020 release.
  • New Follica website and unveiling of a clinical treatment to be coupled with at-home treatment regimen.
  • Kythera Biopharmaceuticals embarked on its phase IIa study for Setipiprant as an oral hair-loss prevention treatment.
  • HairCell announced it will initiate a trial for hair growth using a bio-electric stimulation device with growth factor pump delivery.
  • Clinica CFS reported an average of 82% donor hair regeneration while testing its Stem Cell Transfer hair transplant method.
  • HairClone announced new plan to revolutionize the process of cellular hair growth treatment commercialization.
  • Kelopesia was announced as a potential game changing topical cosmetic from Yeditepe University.

Wow, looking back on all of these developments I realize how much of a monster year 2016 really was for us. I have heard people say it in comments before, and I will reiterate it now, there has never been a time like there is now in the landscape of the hair growth industry. We have multiple cellular treatments being developed, JAK inhibitor drugs, a PGD2r antagonist, a topical peptide, a Wnt agonist, a wounding treatment with compounds, a bio-electric stimulation device, and much more. Multiple pathways and approaches are being addressed and the future looks bright. I bet your outlook has changed in just the past several sentences. 2016 was also a very nice year for me and I made some valuable friendships in the hair industry. I am very grateful for those friendships and you know who you are.

Finally, looking ahead I will remark on a topic that I have spoken of in the past and that is gratitude. If you are looking for a way to improve your outcome of receiving one of these hair treatments then find gratitude now. Don’t wait until a treatment is in your hands to appreciate all of this work. As this post has illustrated there is a lot to be thankful for in the hair growth industry currently. Many people have taken the initiative to dedicate their lives to help solving a problem that is perhaps extremely important to you. Take a moment to feel happy about it, say a prayer or whatever you do, write a company an email or a hand written letter to say thanks for what they are doing – let go of the question “when is it coming out?” When it comes out, you will be well aware of it. We are all anticipating that day when one of these new hair treatments is available for purchase. That day will come. And during this waiting process it is important to “recharge” our outlook and keep our perspectives healthy. This post was designed for that.

Until next time, Be well

Kyocera joins the Tsuji party, New futuristic cap for hair growth: Weekly Thoughts 7/16/16

Hello everyone and welcome to a timely edition of Weekly Thoughts,

The news involving Kyocera and Dr. Tsuji in this Weekly Thoughts is perhaps the best development I’ve heard of this year since the original buzz of the Brotzu lotion hit the internet a few months back. This edition also features a new intriguing company that is developing a device to be worn on a person’s head to emit bioelectric signals to hair follicles. Sounds weird? Perhaps, but it is based on legitimate research. Check it out.

Kyocera confirms Tsuji’s Research

It was just about 3 months ago that we learned Dr. Takashi Tsuji of the RIKEN Institute of Japan was finally getting some major support from a Japanese pharmaceutical company to pursue his hair regeneration research. Apparently, things are going well for Dr. Tsuji in the lab. This past week the major electronics company Kyocera announced that they will be establishing a joint venture with RIKEN and the regenerative medicine company Organ Technologies to bring Dr. Tsuji’s hair regeneration treatment to market. In the deal Kyocera will be developing the cell processing devices and RIKEN and Organ Technologies will be responsible for the stem cell culturing and manipulation, the production process, and implementation of the preclinical trials. Continue reading

Yeditepe University Hair Growth Cream

*Update: From a personal friend of mine who lives in Turkey, I have heard that the cream will not be available until around January 2017. This confirms what others have stated in the comments. My apologies for the disappointment, these things do happen. Apparently, stabilizing the cream at room temperature required a bit more effort than was expected. Let’s hope for the best.*

A research team from Yeditepe University in Turkey recently announced that they will be launching a hair growth cream within the next two months. The team is headed by Prof. Fikrettin Sahin, head of the Department of Genetics and Bioengineering at Yeditepe University. The news was made public last Friday during a press conference that was held at Yeditepe University to announce the new hair growth cream. The product reportedly contains molecular derivatives of stem cells taken from newborn foreskins.

Say what?

For those new to the subject, that might sound a little strange. This is actually not the first time that foreskins have been used as the source of a hair growth product. Histogen has been using fibroblast cells from newborn foreskins for some years now. As funny as it may seem, these cells are targeted for a few specific reasons: 1) The foreskin tissue will otherwise be discarded if not used for scientific practice and there is a continual supply of them . 2) Any type of stem cell in a newborn baby is highly potent because there is still a lot of growing and generation to be done in the tissue and organs of a baby. Continue reading

Weekly Thoughts 2/8/16

Hello everybody, nice to be back here with you again. There seems to have been a surge of hair growth related news as of late which makes it a great time to do some reporting on the subjects. Without further ado, your weekly thoughts.

COL17A1 and Hair Follicle Aging

A major key to understanding the process of hair follicle miniaturization has been discovered and could lead to new therapies aimed at keeping hair follicles cycling healthily. Emi Nishimura and Hiroyuki Matsumura headed the team of researchers at the Tokyo Medical and Dental University in Japan where the research was carried out. The findings were released in an article for Science magazine earlier this month. The article explains that Nishimura et al. examined hair follicle stem cycle growth cycles in mice which lead them to notice a depletion of a protein, Collagen 17A1, in older follicles. The lack of Collagen 17A1 is caused by age related DNA damage. When there is a lack of Collagen 17A1 the hair follicle stem cells turn into skin-producing cells also known as keratinocytes. Thus, when the hair follicle stem cells turn into skin instead of turning into cells that feed hair follicles, the hair follicles of the scalp become smaller. And there you have it.

So, how is this useful? The main idea here is that age related DNA damage leads to a lack of Collagen 17A1. This would lead me to believe there are three useful avenues to pursue for actualizing this research to grow hair. 1) Prevent DNA from being damaged. 2) Add a supply of Collagen 17A1 to the scalp. 3) Do both. I was surprised to read that Collagen 17A1 is a protein. That seems rather interesting because proteins can easily be synthesized (created in a lab). I would assume that the idea of administering COL17A1 to the scalp through injection or topically is already in motion.

Foxc1 also in the Mix

The COL17A1 news was also coupled with the release of research done by Rui Yi and colleagues at the University of Colorado, Boulder. Yi, a biologist at UCB, found that a transcription factor known as Foxc1 also plays a role in the hair follicle growth cycle. Through research done on mice Yi and colleagues found that active hair follicle stem cells express Foxc1 to pause their growth cycle and go into a dormant stage. When the team bread mice with the Foxc1 removed from the mice biology, the hair follicle stem cells did not go into a dormant state. Yi noted that by interfering with Foxc1 or removing it completely there is the potential to induce continued hair cell proliferation which leads to hair growth.

Dr. Brotzu Hair Growth Lotion

Ciao, bella. Italy has always been a place of interesting hair growth research. The latest news comes from Dr John Brotzu a vascular surgeon of the University of Cagliari, Italy. Apparently, a lotion has been developed that can halt the progression of hair loss and regrow hair. Dr Brotzu discovered his potential treatment for hair growth when testing a drug for vascular insufficiency in patients with diabetes. Interestingly, hair loss on the legs is a common symptom of vascular insufficiency. After observing the effect of the drug on the patients in the study, one of the doctors in the study suggested testing the compound on a nurse with hair loss at the hospital. Initially, the concoction consisted of PGE1 (Prostoglandin E1), but when Brotzu and his associates found out that PGE1 would have to go through lengthy clinical trials because it was considered a drug they searched for an alternative. Their solution was DGLA or Dihomo-Gamma-Linolenic-Acid which is a precursor to PGE1. DGLA would be much cheaper and faster to implement because it is considered to be a cosmetic. Dr Brotzu reported that the replacement ingredient had the same effects as the original and went forward with the research. Update: There is still one more clinical trial for this product planned in March 2016 and if all goes well it could be available in 2017. Sounds fun.

Here’s some (translated) quotes from Dr Brotzu on the scientific action of his product.

“It is known that prostaglandin E1 acts on the endothelial cell receptors by stimulating growth of new capillaries by improving the functions of the skin cells. It also produces a vasodilatation of these which can determine the healing of skin diseases and improve the blood flow of the hair bulb.”

“Equol and DGLA have two different actions. The equol blocks the synthesis of dihydrotestosterone from testosterone, preventing it from causing a contraction and narrowing of vascular sphincter. The DGLA acts on microcirculation, improving the elastic features of endothelial cells, making pervious and increasing the ability to generate neoangiogenesis (formation of new capillaries).

The product that Dr Brotzu will reportedly bring to market involves cationic liposomes for delivery, Dihomo-Gamma-Linolenic-Acid (DGLA), equol, and carnitine. According to Brotzu, the synergistic effect of DGLA with equol and carnitine produces an effect that is much greater than any of them separately; the cationic liposomes get the ingredients to the important parts of the scalp biology so they can be effective.

Everything about this sounds well. Dr Brotzu is a reputable doctor and like most cases in hair growth discovery this phenomenon was found while attempting to treat another medical condition. Dr Brotzu’s father actually discovered a specific type of antibiotic named cephalosporins and has a university medical building named after him.

If this product will actually turn out to be a viable treatment for hair growth, like every new product that is announced, we will just have to wait and see.

Background

– An interview from the University of Cagliari.
– A 2016 interview from an Italian hair website.
– A 2015 interview from an Italian hair website.

Ultimate Guide to Hair Regeneration 2016

Updated September 2016

This post contains a list of the most viable and relevant hair regeneration treatments that are known about. This list contains treatments which are in the development process. Certain treatments have a greater potential than others to grow significant amounts of hair, and so I have listed them in order of relevancy. Relevancy in this case is my opinion of the treatment’s combined efficacy and likelihood of becoming available the soonest. #1 is the most relevant and so on.

1. Shiseido/ReplicelReplicel’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 in terms of developing 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 processes for stem cell technologies. In other words, Japan is the ideal place to launch a new stem cell technology. To be clear, Shiseido and Replicel are separate companies. Replicel has licensed Shiseido the rights to bring RCH-01 to the world more quickly through Japan. It is worth mentioning that Shiseido also has its own scientists who are working on hair regeneration through iPS cells. This technique is considered a “next level” type of cellular treatment that could 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 sometime in 1st half 2017 for approval in North America.
Status: Shiseido’s Japan trial is launching now 3rd quarter 2016. Estimated market release by 3rd quarter 2018.

2. Histogen Histogen’s Hair Stimulating Complex (HSC) is a cell conditioned media that is derived from neonatal cells grown under embryonic-like conditions. It is an injectable serum that is used to stimulate the growth of new hair follicles as well as existing ones in a person’s scalp. This treatment has been around since 2008 and a lot of people are eager for it to be released on the market. HSC has shown visual evidence of its efficacy and has had great numbers in clinical trials. No photo was more talked about than this one which was released after CEO Gail Naughton presented at last year’s World Congress for Hair Research. Compared to its initial inception, the HSC product has been refined over the past few years to contain less cellular impurities and be a more concentrated formula of growth factors.
Points of Interest: This is a treatment that has a very high appeal due to its ease of application. Theoretically, you could walk in, receive injections, and walk out. No need to harvest your own cells and come back to get them re-injected such as with other cellular based treatments. The photo results are intriguing and apparently the actual treatment will include more injections than the trial amount. This product could be out in 2017.
Status: Phase III trial for approval in Mexico could be underway currently. Histogen is also presently looking to launch a trial for approval in Japan and China. Set to be on the market in Mexico in 2017.

3. Brotzu Lotion This hair growth treatment went from being internet speculation to #3 on the Ultimate Guide list in record time. The “Brotzu Lotion” is a product that has been created through the work of Dr John Brotzu, a vascular surgeon from Italy. This hair growth treatment was discovered when Dr Brotzu was testing a formula to treat vascular insufficiency in patients with diabetes. It was noticed that this treatment regrew hair on the patient’s legs which lead Brotzu’s team to trial the formula on people’s scalps. The formula was modified to use DGLA instead of PGE1 because DGLA would not be classified as a drug and would require much less clinical trials to be approved. The known ingredients of this lotion include DGLA, Carnitine, S-equol, and Cationic Liposomes. The pharmaceutical company Fidia has acquired the rights to manufacture the Brotzu formula and is apparently performing a clinical study with the lotion for use in people with AGA. The study is being done in 2016 and if all goes well Fidiawill make the lotion available in early 2017.
Points of Interest: Dr Brotzu has been a well known and reputable vascular surgeon in Italy for decades. All of the science adds up and the fact that Fidia got involved seals the deal. Dr Brotzu has also released a compelling photo of a young girl with alopecia areata this year who used the lotion and got impressive results. The fact that it could be out as a cosmetic in early 2017 is striking. All eyes are on this treatment.
Status: Clinical efficacy trial is being completed in 2016 with the potential for a release in Italy in early 2017 pending results.

4. RiverTown Therapeutics Inc. RT1640 is composed of minoxidil, cyclosporine-A, and a novel drug RT175. This compound has been developed by the founder of RiverTown Therapeutics Inc., David Weinstein MD, PhD. In a Phase 1 trial 100% of the people who used the treatment had satisfactory hair growth and, reportedly, several people had complete hair regeneration. RiverTown Therapeutics debuted their fantastic hair growth results, found on the link above, on Follicle Thought. The three agents in RT1640 act on distinct pathways of AGA and synergize to promote the growth and maintenance of hair follicles. RT1640 also reanimates the melanocytic progenitor cells which give hair it’s color, and hence RT1640 restores pigment to regenerated hair as well. Interestingly enough, RT1640 was brought to life through it’s founder’s own interest to restore his hair growth.
Points of Interest: These results for RT1640 are the most significant hair regeneration results I have ever witnessed for a topical treatment. Not only does RT1640 regrow hair, it also restores the pigment to the hair it regenerates. The strong safety profiles of the three agents that compose RT1640 should benefit the clinical trial process.
Status: Currently raising funds for a Phase 1B/2A study.

5. Tsuji-Riken/Organ Technologies Dr. Takashi Tsuji runs one of the most advanced stem cell labs in the world at the Riken Institute in Japan. Thankfully, he took up the task of using stem cells to grow hair in his R&D and subsequently got some major partners to help further his work. In mid-2016 it was announced that Riken would be establishing a joint venture with the electronics company Kyocera and the regenerative medicine company Organ Technologies to bring Dr. Tsuji’s hair regeneration treatment to the market. In the joint venture Kyocera will be developing the cell processing devices and RIKEN and Organ Technologies will be responsible for the stem cell culturing and manipulation, the production process, and implementation of the preclinical trials. The treatment involves extracting a small number of hair follicles from a person’s donor scalp area and then isolating two specific types of cells from the follicle – papilla cells and epidermal cells from the bulge region. These cells are then cultured, expanded, and combined to create a hair follicle “germ” or “follicular primordium.” Once the hair follicle germs are ready they are transported to a facility where they can be implanted back into a person’s scalp to grow hair.
Points of Interest: Tsuji has been doing hair follicle research for several years now and it’s awesome that the strategic partners are finally in place to bring his hair growth treatment to the world. Organ Technologies will be develop this treatment in Japan by which currently has the fastest track to market approval in the world for cellular therapies. Kyocera has announced that they aim for this treatment to be on the market in 2020.

Status: Currently undergoing research and development with a goal of market release in 2020.

6. FollicaKnown for being one of the quietest companies on the horizon of hair growth treatments, Follica is also one of the most anticipated. Follica was founded around 2008 and was based on the science of creating hair follicles through creating tiny wounds in the scalp. Since their original clinical trials that did not bring about the desired results Follica has continued it’s research and development on combining novel compounds with micro-wounding for the proliferation of hair follicle formation. Follica has also announced that they are developing an at-home system to be combined with their out-patient micro-wounding therapy for hair growth.
Points of Interest: Follica’s founder Dr. George Cotsarelis is one of the household names in the hair follicle research world and has an array of hair growth related patents under his belt. About 8 years deep in development, Follica is planning to initiate a pivotal trial in late 2016/early 2017 which, pending results, could lead to Follica’s hair growth therapy being approved for the market sooner than later. In October 2016 Follica rolled out a new website that depicts a smartphone app to be coupled with their therapy regimen. The treatment, though not fully disclosed yet, stands to be a brief and tolerable procedure.
Status: Aiming at FDA clearance in 2017 for a commercial release in 2018.

7.  FollicumFollicum is a Swedish biotechnology company that is developing human peptides for the use of stimulating hair growth and inhibiting hair growth. The lead candidate peptide that Follicum is called FOL-005. Specifically, it is called FOL-S-005 when being used to stimulate hair growth. Yes, interestingly enough, the same peptide is used to grow hair and also inhibit hair growth. According to the CEO of Follicum, Dr. Jan Alenfall, various factors will decide what effect is attained from FOL-005; some of these factors include dose, the way it is administered, and the type of hair follicle being treated. It seems to me that Follicum has the ability to control the effect of it’s peptide well in hand. FOL-S-005 will be commercialized as a topical solution according to Follicum’s website.
Points of Interest: Follicum has initally been very kind to Follicle Thought and debuted a graph of their pre-clinical trial results on this site. The hair growth effect of their peptide was originally observed in mice in 2004, accidentally. This means they’ve had 11 years to conduct R&D on this discovery. Follicum has been working with renowned hair researcher Ralf Paus since 2012. They’re initiating human trials which are set to begin early 2016 and have secured two major manufacturing partners for their peptide technology.
Status: Beginning Phase 2A trial in September 2016

8. Clinica FCS (Stem Cell Transfer)Christophe Guillemat of the CFS Barcelona Hair Transplant Clinic has been researching a method of extracting hair follicle stem cells from the donor area and utilizing them for hair transplants. I’ve previously made a post about this trial when it was first announced. Guillemat’s method appears to be a similar in concept to the one used by Dr. Gho. At the beginning of summer, the doctor announced that he had begun a trial with 20 patients after he saw good results in his first ‘test’ patient. The results from the 20 patients were set to be announced in September 2015, but it appears he is conducting another round of treatments on the same 20 patients to determine if his method does indeed leave intact an unlimited donor availability. Presumably, the cells that he is injecting to the recipient area are currently growing hairs.
Points of Interest: It’s still in the development phase. The results from the 20 patients should be known by mid 2016. The initial trial done on one patient, which is depicted here, showed good results. If Guillemat can achieve his goal of unlimited donor availability and share the technique with other respected doctors, we will be at a whole new level of hair restoration. Here’s the latest information about the technique.
Status: Trial results have been released and the procedure showed efficacy, however, the clinic is now working to improve their results before offering the procedure to patients.

9. SamumedSM04554 is a small-molecule topical solution that activates the Wnt pathway to grow hair. In March 2016 Samumed presented their highly anticipated Phase 2 results at the American Academy of Dermatology. The Phase 2 results got a mixed response from the online world of hair growth enthusiasts, but the bottom line is that the treatment grew hair in the trial. Approximately a 10% overall increase in hair density was observed in the best responding group who used SM04554. Before the end of that study, Samumed initiated a second Phase 2 study with a scalp biopsy analysis to better understand how their molecule gets the hair to grow. The initial Phase 2 trial lead to the conclusion that this drug does not contain a “dose response” in patients who use it. This means that adding more of the drug does not lead to more results. Finding the “just right” dosage and application is important for this drug to work it’s best.
Points of Interest: Samumed began by breezing their way through clinical trials and completed an important Phase 2 within about two years time from their initial startup. Now the company is looking into ways to optimize it’s drug to grow hair without a dose response and get to a Phase 3 trial.
Status: Have recently completed the biopsy analysis Phase 2 trial. Next step is yet to be announced. 

10. Allergan – Bimatoprost is a liquid topical solution originally used to enhance eyelash growth. It is the active ingredient in the product Latisse. Allergan has been testing Bimatoprost for hair growth on the scalp over the last several years. There have not been many announcements from Allergan during the course of the Bimatoprost trials, but there have been positive indicators. Also, in mid 2015 Allergan acquired Kythera Biopharmaceuticals, the company trialing Setipiprant for hair growth. This means Bimatoprost and Setipiprant are being developed under the same roof now. Bimatoprost is said to have a positive effect on PGE2 levels, while Setipiprant is a PGD2r antagonist. Hair loss researchers have theorized that those two effects would be an ideal combination for stimulating hair growth. Allergan has developed a new Bimatoprost formulation for the scalp in 2016 which has been enlisted in a new clinical trial process.
Points of Interest: It’s a product that has already been FDA approved to grow a type of body hair, eyelashes. Allergan has plenty of funding to get the trials done as quickly as possible. If all goes well, this should be out sooner than later. And, if Bimatoprost has no side effects and has similar growth results as Minoxidil or Finasteride, it’s a winner. It theoretically couples very well with its new in-house hair growth teammate Setipiprant.
Status: Phase I trial for new formula to be completed in October 2017.

11. Kythera Biopharmaceuticals Setipiprant is an oral medication or pill. Specifically, it is a prostaglandin 2 receptor (PGD2R) antagonist. It was previously developed for medical applications aside from hair loss and has undergone clinical trials. After George Cotsarelis at UPENN discovered that PGD2 receptors potentially play a major role in hair growth, Kythera began pre-clinical trials with Cotsarelis’ office to determine if PGD2r antagonists were worth developing as a hair loss treatment. About two years later, Kythera announced it acquired the rights from Cotsarelis to use Setipiprant as a hair loss treatment. Setipiprant is now undergoing a Phase IIA clinical trial in which finasteride is one of the control vehicles. The study is to be completed in September 2017.
Points of Interest: Setipiprant has already undergone a Phase III trial in the US. This should cut out a large portion of the time it usually takes to undergo the typical FDA trial process.
Status: Undergoing Phase IIA clinial trial with a completion date of September 2017

12. Dr. Colin Jahoda & Dr. Angela Chrisiano Two of the most prominent names when it comes to hair follicle research. Dr. Jahoda’s latest public work has been focused on 3D dermal papilla culturing, while Dr. Christiano has been popping up frequently in news headlines for her research on JAK inhibitors and hair growth. Even better, the two of them are reportedly teaming up on Christiano’s new startup “Rapunzel” which is developing a treatment using cultured hair follicle cells to regenerate hair. It is a popular approach these days and I am very interested to see what these two pioneers come up with.
Points of Interest: Dr. Jahoda implanted his own hair cells into his wife’s arm and found that the cells grew hair on her arm all the way back in 1999. Currently, it has been reported that his 3D method is being trialed in Taiwan. Hearing the results from those trials will be extremely interesting. Dr. Christiano has been gaining some momentum with the recent finding that Ruxolitinib is a potential full on cure for alopecia areata.
Status: Dr. Jahoda’s study will conclude December 2016. Dr. Christiano has recently sold her JAK IP to Aclaris who is carrying out the trials for use in AGA.