Updated on October 15, 2016
The times they are a-changing.
Nowadays you can’t even take a trip to the fridge to grab more hummus dip without some hair bio-tech startup rolling out their new website and business plan.
Jokes aside, Follica has been the ultimate tight-lipped company in the hair regeneration biz for about 8 years now. To be honest, I understand the approach. You keep working on the treatment behind closed doors until you’ve got something that really works and all of the sudden you hit the world with a Hoo-Ah that would make Al Pacino proud. At least that’s how I like to think of it. Anyways, let’s just take a look at the new revelations.
For starters here’s the syntax from Follica’s new layout:
“Our technology is based on a proprietary approach intended to create an “embryonic window” in adult skin, allowing new follicles and new hair to form from epithelial stem cells. Following skin disruption, cells that migrate to help healing are forced to make a decision: Should I make epidermis, or should I make a hair? There is a window of opportunity in which we can potentially push them to choose the latter, and we believe there are multiple biological pathways to target to enhance this outcome. This regenerative effect is called hair follicle neogenesis.”
The significant info on Follica’s new website:
- Non-invasive skin disruption treatment to create new follicles done in-office by a physician
- At home device + topical compounds to maintain and continue the new hair growth
- Smartphone app to remind users of their treatment times and re-order supplies
- A doctor affiliate program
This is a thoughtful program that Follica has created. The at-home device and progress tracking app are welcomed ideas and should improve compliance.
The only question left is…..how much new hair are we talking about here, Follica?
Credit to Stump at HLT on the find
Updated on October 11, 2016
Hello everyone and welcome to another edition of Weekly Thoughts.
Things have really busy in the hair world as of late, new companies are popping up all the time and companies that we have known about are finally making the announcements we’re looking to hear. Lo and behold it’s almost been two months since the last edition of Weekly Thoughts due to all of the feature articles! Let’s get into some news from different sectors across the hair growth industry.
Cosmetic giant L’Oreal has announced that they are partnering with a French bio-printing company named Poietis to take on the monumental project of 3D printing human hair follicles. Poietis uses an advanced form of laser-printing cell-based materials which makes them an ideal partner for the task of hair follicle printing which has not been attempted before. One of the advantages of laser bio-printing is that it does not involve “pushing” the cellular materials out through a nozzle, which is the approach taken by most of the industry. Through the laser technique Poietis is able to print without putting additional stress on the cells which helps keep them intact. Initially, L’Oreal will be using the engineered follicles to test their new hair growth products. This will provide them with a safe and expedited approach to trialing new hair growth compounds. Here’s a look at Poietis’ very neat laser printing technology:
But will they attempt to mass breed hair follicles to create an unlimited donor supply for hair transplants? Yes, they will. No one knows how long that process could take, and it will definitely be some years before that treatment would be out on the market, but at least they are interested in that potential. In the meantime, this could really boost L’Oreal’s efforts to put out a really good hair growth cosmetic and give them some extra insights as to exactly how these fascinating little hair follicles are created in our scalps. Source article here.
Love for the AA Crowd
News on alopecia areata treatments is not a common item on this blog, but I do like to support the crowd of people who deal with this autoimmune issue when I can. The drug ruxolitinib, a JAK inhibitor, showed up in the news again a few weeks ago for it’s use to regrow hair for people with AA. It is quite amazing just how much hair ruxolitinib is able to regrow for alopecia areata patients. This is the same drug that Dr Angela Christiano researched, along with tofacitinib, which caused a quite a stir last year in the online hair discussion world. The intellectual property from that research was eventually sold to Aclaris Therapeutics, who we know is pursuing clinical trials for the use of JAK inhibitors in treating alopecia areata, as well as common pattern hairloss.
I debuted some impressive photo results of the pharmaceutical-in-training, RT1640, a few weeks ago. In my opinion, this treatment deserves more attention for the potential it brings to the table as a home-use hair regeneration treatment. In the original post I noticed there were some speculative comments about the photos, which is not rare for the internet. So, I decided to run the photograph through a lighting filter to see if I could “shed some light” on the situation (ok sorry, but hopefully that made you laugh). There’s no two ways about it, this guy regrew a good amount of hair in the second photo. Keep in mind, these results came in at 3.5 months, imagine what they might look like after a full year…
Histogen is Coming to China
Histogen has offically agreed to license it’s hair growth product, HSC, to Pineworld Capital of China. Through this agreement Pineworld Capital will be commercializing HSC to the world’s largest national population of China. They’re probably gonna get a few tourists to visit as well. Histogen will receive milestone payments on the sales of HSC from Pineworld Capital as part of the agreement. According to this article Gail Naughton of Histogen is looking to go straight into a Phase III (final) trial for HSC approval in China.
Naughton also mentions that Histogen is considering going forward with a study for HSC as a preventative hair loss treatment for women undergoing chemotherapy.
Stem Cell Extraction in Spain
Clinica FCS is a hair transplant clinic in Spain that has been working on a method of extracting follicle stem cells and re-implanting them into the scalp for over a year now. The theory is similar in nature to the technique of Dr. Gho of the Netherlands. Clinica FCS will remove just the stem cells from a hair follicle with very fine instruments and then implant those stem cells into the recipient area of a patient’s scalp. The proclaimed advantage of this procedure is to not damage the donor hair follicle, as is the case with the more common FUE, and thus creates a virtual unlimited supply of donor hair. That was what they were aiming for, at least.
After a year’s wait the results are finally in from the first several patients that trialed this technique being dubbed “Stem Cell Transfer” by Clinica FCS. From three paitents the clinic reports an average of 82% total donor hair regeneration. That’s not bad.
During the Stem Cell Transfer procedure stem cells are extracted from all of the donor follicles. Clinica FCS reports that currently 50-60% of the extracted stem cells are producing hair growth in the recipient area but hope to get that number up to about 90% after further developing the procedure. Here’s some photo results of patient “Toni” who had 78.45% regeneration of his entire donor area.
I’d say these results are quite interesting and I look forward to further developments from Clinica FCS on their SCT technique. It is great news that hair restoration is evolving at all levels. Salutations to all of the fine people across the world who are engaged in this work.
Until next time, Be Well.
Updated on September 28, 2016
I had the opportunity to speak with Paul Kemp PhD this week about his new hair growth venture, HairClone. Paul shared a brief presentation with me about the concepts and business plan that HairClone is based upon. I can say I am genuinely impressed, there is evolution here. An experienced medical and business team, elements of crowd funding, and an ideal medical development system are all part of the formula that makes HairClone.
The formula that HairClone is based upon could be described as “innovation.” The true innovation of HairClone is not so much the treatment itself, as others are working on cellular treatments, but more so the format in which HairClone will develop their treatment. They are calling the process “Medical Innovation” and are bringing together groups of patients and clinicians to co-develop the treatment. This is similar to the process that hair transplantation has followed. In hair transplantation, surgeons began with hair plugs, then strip surgeries, and eventually FUE surgery was developed and refined with the patients to the benefit of the patient. HairClone plans to integrate that process of ‘treatment practice of medicine’ with ‘scientific advances’ into hair cloning treatments. From HairClone’s website:
“The basic elements of hair cloning involves obtaining a patient’s follicles, dissembling them to obtain the required cells, expanding these cells in culture and then re-implanting them in the patient. Some of these stages are already understood and HairClone will optimise each in parallel both in the laboratory and the clinic in order to develop an effective therapy.”
Sounds brilliant, but how is it possible? Paul has worked extensively in the US and UK and feels that this process of Medical Innovation for hair cloning can best be carried out in the UK. In the UK a doctor may decide under his or her own judgement that a treatment is suitable for their patient and administer that treatment to their patient. There are regulatory criteria that the treatment must meet in order to be used under the regulator’s so called “Specials” exemption. The biggest factor is that the decision to use the treatment has to come solely from the doctor and the company developing the treatment must not market their treatments to doctors or make any claims about said treatments.
In other words, through Specials the doctors are empowered to utilize a treatment that under their best judgement they believe to be safe, and believe is likely to be effective for their patients when a licensed alternative treatment is not available. When first hearing about this system used in the UK I was surprised and also impressed. It is a modernized development and I hope that other countries would take a look at a system like this and consider it for their own use.
Because of this Specials system, HairClone isn’t going to need to develop their treatment in isolation, carrying out clinical trials for several years and then launching the treatment onto the market. They will make use of an iterative approach, constantly learning and adapting through the tried, tested, and successful approach of Medical Innovation.
Another innovative facet that really stood out to me from the slideshow is the community based approach HairClone is taking to create their solution. The HairClone treatment is aimed to work in conjunction with hair transplantation. Said treatment could potentially be useful for people who were not previously a good candidate for hair transplant surgery and especially younger patients who would have traditionally not been good candidates for surgery due to the uncertainty of their future hair loss. I know some of you are getting ready to ask, No, this does not mean that HairClone is only going to be used during a hair transplant surgery. What it means is that this treatment is aimed to be conducted in offices already practicing hair transplant surgery. I like this because I feel that it removes the apprehension that a hair transplant surgeon might have towards a cellular hair growth treatment and encourages cohesion and optimism.
Also, as you’ve heard before HairClone is looking into both equity based and reward based crowdfunding to help finance their developments. This is something that myself and many others have been calling for in hair growth research for quite some time. It would be a wonderful sight to see the world come together and be successful in supporting a new treatment that is able to restore hair in a graceful manner.
HairClone aims to begin follicle banking for patients in the UK in 1st half 2017 and transplanting cellular treatments in 2nd half 2017, though this is dependent upon HairClone getting sufficient investments to carry out their development plan.
Commentary for the Enthusiasts
I know that even at this stage inquiring minds are going to want more details about how HairClone aims to get it done. I did have a brief segment at the end of the presentation to ask Paul a few questions that I thought the readers of this site might ask. Here’s a little more background info on how HairClone got started and how it may work out:
FT: What was the deciding factor that made you want to get back into hair growth research and launch HairClone?
Paul: Hair research has been in the back of my mind since the program at Intercytex ended prematurely due to a lack of funding. The paper by Claire Higgins et al in 2013 really peaked my interest and got me back into thinking about this (hair regeneration). I spoke to Vincent Ronfard about the paper and we thought “let’s have another look at it.” I then had a discussion with Dr.s Bessam and Nilofer Farjo about the subject and they said that they still get inquiries all the time from patients about hair cloning treatments. The Dr.s said they were interested in the new project, but instead of just participating in the clinical trial, this time they wanted to be involved from day one in the development.
FT: Is the 50 hair follicles via FUE planned to be enough for a lifetime of HairClone treatments for a person?
Paul: The short answer is that the process is still iterative at this point. We estimate that a person with hair loss loses about 50,000 hairs over the course of their life. In the culturing process we usually get about 10X the amount of cells at each of three passages, so a 1,000 fold increase in total. The theory that we have at this point is that from 50 hairs we’d get about 50,000 hair cells. Whether this would be turning vellus hairs back into terminal hairs or generating new hair follicles we don’t know at this stage. All of this is estimated for now, but of course it is possible to go back and get more FUE at a later point if necessary. What we don’t want to do is harvest many more follicles than we need from a patient.
FT: Do you plan on using a 3D culturing system for this treatment?
Paul: At this point we still don’t know. There are many different culturing options, including 3D culturing, that are available and through our research we intend to find the one that works the best. The technique’s used by Claire Higgins give us the tools to rapidly determine which system works best before we use the cells in the clinic. This process will be supported by our follicle banking system so that when, as we are hoping, the culturing system improves we would then be able to utilize the hair follicles that are banked and create cultures using the new culturing system.
FT: Thank you Paul for sharing this information for the readers of Follicle Thought.
Updated on September 9, 2016
I almost couldn’t believe my eyes when I started browsing the website for HairClone, a new hair regeneration startup based out of Manchester, UK. Just like that another hair growth technology company has sprung up seemingly out of nowhere, and they have a very interesting plan to make hair regeneration a reality.
Update: The Personnel Section has been updated 9/8/16 Check it out
HairClone is based on a model of “banking” a person’s extracted hair follicles in cryopreservation which can be used later when the HairClone cellular therapy has been fully developed. HairClone notes that the younger the follicles are, the more potent the cells within them may be. When HairClone’s cellular therapy is ready to go a patient’s follicles will be taken out of preservation and then dissected, expanded in culture, and micro-injected back into the person’s scalp. Apart from the cryopreservation banking, it’s a format we are familiar with. HairClone intends to raise funds for further research and create a patient pool through offering hair follicle banking initially.
There’s a lot of good information on the HairClone website about the companies plans for development and growth. The website even mentions plans for crowdfunding and getting input from patients to develop their treatment. Here are the most informative quotes from HairClone’s website:
“Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality. Recent scientific breakthroughs however indicate how culture multiplication systems could be developed which is why we have created HairClone Inc. now.”
“In order to develop a successful system that uses hair cloning for the treatment of androgenic alopecia, HairClone will need to develop strong and continuing interactions with leading hair transplant surgeons, scientists and forward-thinking patients in order to successfully carry out the various scientific and clinical developments.”
“HairClone will generate funding to carry out this research and clinical development in a number of ways: Clinic Membership, Follicle Banking and Storage, Pre-payment or reward based crowdfunding, Cell Treatment, and Investing in HairClone.”
“The banking activities could start within a year and will create a patient pool and short-term revenue to the company which will help support the clinical and product development and bring it closer to clinical reality.”
About The Treatment
“When the process for expansion and re-implantation has been developed by the scientist/clinician/patient partnership, portions of the banked follicles would be dissociated and expanded in culture, transported to the treatment clinic where they would be micro-injected back into the scalp. It is expected that this process will both rejuvenate miniaturising follicles as well as inducing new follicular structures. This process could be repeated every 2-3 years as the balding process continues by taking additional portions of the patient’s banked follicles and expanding them.“
“In a later version of the product injected cells would be able to create brand new hair follicles by a process called follicle neogenesis.”
“..We expect that this could be in the clinic within the next few years although it will take several years before it is fully licensed around the world.”
From Twitter: “Had great @webex with @BessamFarjo and a German company that has an nice technology that could be great fit with HairClone. More to follow!”
Wait, so I didn’t say who was responsible for HairClone yet? You’re right. I wanted to build up a little suspense, this is the internet after all. The CEO at HairClone is Paul Kemp PhD who has over 25 years experience in the field of Regenerative Medicine. What’s even more compelling is that Paul was the sole founder of Intercytex aka the first company ever to trial cell therapy for hair growth. Intercytex was eventually unsuccessful at getting significant results in their hair growth trials, however, that experience and background is a big plus and adds credibility to HairClone. Vincent Ronfard PhD serves as CSO at HairClone and his resume boasts over 26 years of experience of applied research and product development in the fields of regenerative medicine, wound healing, and cosmetics.
Paul and Vincent have teamed up with two clinical partners so far, Dr. Bessam Farjo and Dr. Nilofer Farjo, both hair transplant surgeons of The Farjo Hair Institute of London, UK. Here’s a tidbit that you might have been unaware of, Dr. Bessam and Dr. Nilofer Farjo carried out the original Intercytex trials with Paul Kemp!
There is also one member of the scientific advisory board at HairClone, drum roll please…..Dr. Claire Higgins! Dr. Higgins is currently faculty at the Department of Bioengineering at the Imperial College London. She has also done postdoctoral training in the laboratory of Dr. Angela Christiano, one of world’s most renowned hair follicle researchers. The HairClone website mentions that more scientific advisory board members will be announced soon. Is it just me or is it starting to feel like Christmas already? 🙂
Not surprisingly, I really like this company HairClone……but I think I like that picture of Claire Higgins even better.
Updated on October 22, 2016
I’m very happy to be bringing you all an incredible exclusive on Follicle Thought. This week David Weinstein, MD, PhD of RiverTown Therapeutics Inc. reached out to me to share some amazing photo results of his new compound RT1640. Below you will find photographs of a 60+ year old woman and a 42 year old man that received the RT1640 treatment. Both of these results came within 4 months of trialing the compound. Very impressive.
Worth a Thousand Words
I knew that if the photographs showed that much hair regrowth then the result must have been even more impressive in real life. David confirmed this to me when he remarked “both the man and the woman are ecstatic with their results.” I believe it.
With landmark results like these I knew the interest in RT1640 would be sky-high. To give you a greater picture of what’s going on at RiverTown Therapeutics Inc. I asked David to answer a few questions for the article. This is a brief interview, but all of the information is there and you will be surprised by what you read probably more than once.
Interview with David Weinstein MD PhD
FT: Can you tell us about your background in biotechnology and what lead you to hair growth research?
DW: RiverTown Therapeutics Inc. is my third biotech start-up. I enjoy building things. This includes building companies and building therapeutics. My other companies have been in the area of neurology and neuro-regeneration, which is in keeping with my professional training. I came to hair regeneration through a combination of curiosity and vanity. I lost a good deal of my hair precipitously and didn’t care for how I looked. My attitude when confronted with a problem is to think about the cause and the ways to address the problem. I needed to learn about hair, and especially about androgenic alopecia (male pattern baldness). I spent a day or so with my good friend, PubMed. The take-home message was that AGA was simple, but hair regeneration was a complex problem that like effective cancer therapies, was likely to require targeting multiple pathways. These pathways included expanding follicular stem cell pools, promoting their migration from the bulge to the follicle, driving their differentiation into the growing hair shaft and supporting the mature hair.
FT: How did you discover this combination of three agents?
DW: I remembered from my clinical training seeing kids treated with minoxidil- they had hair everywhere. The same was true of people treated with cyclosporine A- they too were hyper-hirsute. A review of the literature suggested that in spite of the exaggerated hair growth in patients taking theses drugs by mouth, minoxidil didn’t do much when applied topically to the scalp in AGA, and cyclosporine A did less. The two together had neither additive nor synergistic effects. Taking them orally was out of the question, as these are serious drugs with serious side effects. In addition to CSA and minoxidil the third drug is one I had created as a New Chemical Entity (NCE) several years ago, called RT175. Among other things, RT175 promoted the recruitment and differentiation of follicular stem cells. The three agents act on distinct pathways in hair regeneration and together, they synergize to promote the growth and maintenance of hair in men and women with androgenic alopecia. They also reanimate dormant melanocytic progenitor cells. These are the cells that add color to the hair. When the hair grows back with RT1640 treatment, it is the color that you had before it turned gray and fell out.
FT: Please tell us where RT1640 is right now in terms of the clinical trial process and what the next step is for it?
DW: We are currently raising funds to pay for a Phase 1B/2A study, and NIH document submission. We have established in a small number of people that RT1640 works: 100% of the people that have used it have had satisfactory growth and a significant percentage have had complete hair regeneration. As soon as we have the required funds, we will push forward. To that end, we are seeking interested strategic and venture partners.
Thank you very much for taking the time, David.
Wow. It’s clear RiverTown Therapeutics Inc. has a potential goldmine on it’s hands. Venture capitalists take note. Hair enthusiasts rejoice.
Updated on August 28, 2016
Follicle Thought recently had the opportunity to interview Howard Leonhardt of Leonhardt Ventures about his interesting new invention aimed at hair regeneration, HairCell. The Chief Medical Officer of Leonhardt Ventures, Dr. Leslie Miller, also provided some input for certain questions in the interview. Dr. Miller is also Director of the USF Heart Institute and has co-authored one of the leading textbooks on Stem Cell Therapy for Cardiac Regenerative Medicine.
The topics covered in this interview include Howard’s extensive background working with stem cells to regenerate organs over 20 years ago, the planned clinical trial pathway to bring HairCell to market, and an in-depth explanation of how this technology actually works in the human body.
FT: For starters, can you tell us about your background in regenerative medicine?
Howard: In 1985 we began work with Dr. Robert O. Becker, the author of the book Body Electric, to explore use of bioelectric stimulation for improvement of blood flow. In 1988 we completed our first muscle stem cell repair of a large animal heart with Dr. Race Kao and Dr. George Magovern which was published in 1989 in The Physiologist. That same year I developed the ProCell stem cell micro needle delivery catheter that was later patented. In 1991 working with Dr. Stuart Williams we began work cell sodding stent grafts for aortic aneurysm repair. Dr. Williams patented the first method of taking stem cells and endothelial progenitor cells (blood vessel forming) from a person’s own fat tissue. In 1995 we completed the first ever percutaneous repair of an aortic aneurysm without surgery in Melbourne, Australia based on a Taheri-Leonahrdt (TALENT) series of patents. In 1998 our colleague and co-founder Dr. Doris Taylor published in Nature Medicine a landmark paper on muscle stem cell repair of hearts.
In 1999 we patented a biological pacemaker and published in The New England Journal of Medicine our results with non-surgical repair of thoracic aortic aneurysm dissections working with Dr. Christoph Nienaber. In 2000 we introduced the first genetic test for determining heart attack risk on the U.S. market the Pla2 polymorphism test working with Dr. Pascal Goldschmidt. Also, in 2000 I began filing a series of patents for mixed compositions for organ regeneration. In 2001 we completed the historic first-in-man non-surgical repair of a human heart in The Netherlands working with Dr. Patrick Serruys, Dr. Warren Sherman, Dr. Pieter Smits and Dr. Doris Taylor. We went on to complete and publish pilot, Phase I, Phase II and Phase II/III studies for muscle stem cell repair of hearts. That same year I began filing a series of patents for bioelectric stimulation based organ regeneration working at first with Dr. Juan Chachques in Paris and later with Dr. Jorge Genovese of Argentina. In 2003 working with Cleveland Clinic, the University of Florida and Florida International University and the University of Arizona we began testing genetic modification of stem cells to improve regeneration results and the use of nutrient hydrogels. We discovered the strong improved benefits from SDF-1, eNOS, CX-43, VEGF and other proteins. There are dozens of published papers now documenting the stem cell homing and regeneration benefits of SDF-1.
In 2008 I moved out west to California and set up an independent facility, Leonhardt Ventures, to focus on developing organ regeneration therapies with the combination of bioelectric regeneration signaling and micro infusion pump delivery of a mixed multi-component stem cell based composition. This work is done in collaboration with over 35 researchers from around the world with leadership from our great experienced management team, board, and advisors. Since then we have developed more than 30 new inventions related to organ regeneration and have spread out to address many organs including; brain, eye, aorta, artery, skin, breasts, pancreas, liver, kidney, bladder and yes – hair. From our original year, 2000, in which we developed signals of SDF-1 (stem cell homing) and VEGF (blood vessel growth) we have added IGF-1, HGF, EGF, eNOS, Activin A+B, RANKL, Follistatin and Tropoelastin. We are on the track to file patents on about a dozen more signals over the course of this year. We are working on GDF-10 BMP this week and NADA. In 2013 our main bioelectric regeneration research collaborator, and co-author along with myself of many of our patents, Dr. Jorge Genovese, published In Situ Electrical Stimulation Drives a Regenerative Shift in the journal CELL TRANSPLANT. In total we have raised and spent over $145 million in developing our full portfolio of organ regeneration inventions so far since our founding.
FT: What lead you into the field of hair growth?
Howard: The pivotal moment to decide to go forward with hair regeneration was when we discovered the bioelectric stimulation signal for IGF-1. We originally targeted this cytokine for cerebral stroke recovery. We then read that studies have shown it works for hair regeneration. When we added signaling for HGF hepatocyte growth factor, Activin A + B (especially B), Follistatin, eNOS nitric oxide synthase, EGF epidermal growth factor, and Tropoelastin our confidence to pursue hair regeneration grew even further. We believe scalp matrix as a component of our HC-15 composition is also very important.
FT: What research is the HairCell technology based on?
Howard: The HairCell technology is based on our experience since 1985 with bioelectric, stem cell, and growth factor based organ regeneration. Many of the 10 proteins we control expression of with our stimulator have been studied already on a stand alone basis. A number of the components of our 15 component HC-15 hair regeneration composition have also been studied on a stand alone basis. We, ourselves, have complete studies documenting the benefits of repeat delivery of stem cells for organ regeneration purposes. We have combined all this cumulated knowledge and experience into one comprehensive treatment. We plan to publish and present animal study results and the first pilot human study of the full combination therapy in 2017.
FT: How did you come up with the 15 component hair regeneration composition?
Howard: 31 years of experience working on organ regeneration led us to these components.
Dr. Miller: Each of these components have been shown in numerous models and publications to have a beneficial role in tissue regeneration, and several such as IGF and Follistatin to have particular benefit in hair growth. The concept is that each would be additive to overall benefit. Research in the past has focused on individual proteins, but clearly the repair process in the body takes advantage of an array of molecules and cues, and we are building on that awareness. There is no data to suggest that there would be any adverse effect of combining these naturally occurring proteins, such as inactivation or reduction of benefit, and thus we believe that we are ahead of the field, specifically in the area of hair regeneration.There are 4-5 approaches now being used as therapies to achieve hair growth, but none are a part of the body’s native repair mechanics or contain important proven molecular agents such as our combination. We believe that we have the greatest strategy to not just show a small statistical benefit, such as 10% hair growth, but 3-4 fold improvements.
FT: We’ve never seen a device quite like this before in the hair growth tech industry. What kind of a clinical trial process would HairCell follow in order to become available to consumers?
Howard: We plan to implement a three part clinical path. First, one shorter path for just the scalp surface non-invasive bioelectric stimulation combined with topical ointments of known and already approved components. The second path is the same but with the addition of our HC-15 fifteen component composition embedded into the topical ointment. The third clinical path is for our full micro infusion pump delivery of our HC-15 below the scalp deep into the tissue. For all these we plan to start with a small scale dose escalation Phase I clinical trial of about 30 patients at a single center. Then we will go to a Phase II multi-center trial with about 150 to 350 patients. After that we move to a pivotal Phase II double blinded, randomized, placebo controlled trial in about 1500 patients. Our team has brought a number of products through all these phases of clinical trials in the past and knows the pathway well. We hope to start the first OUS (Outside US) Phase I trial later this year and the first U.S. based Phase I study early in 2017. We have reached out to OUS sites in Spain, Canada, Mexico, Czech Republic, Italy, The Netherlands, Argentina, and China. We have completed clinical trials in all these locations in the past. In the USA we have entered clinical trial planning with two centers in California. We are preparing an Institutional Review Board filing to be made for single center dose escalation Phase I safety studies as soon as our pre-clinical safety studies are completed which is expected this fall.
Dr Miller: This device is one of the most advanced approaches to generating electrical stimulation of some of the body’s most important native repair proteins in a directed manner that can emphasize individual target proteins in a sequential manner. There are others working in the area of what has become known as electroceuticals or electric medicine, but no one to my knowledge has the sophistication of this device.
FT: What are some of the reasons you feel that HairCell is a safe technology to use?
Howard: Nearly all of the components of our bioelectric therapy – SDF-1, IGF-1, HGF, EGF, eNOS, VEGF, Follistatin and Tropoelastin and components of our mixed composition – adipose derived stem cells, endothelial progenitor cells, Micro RNAs, exosomes, HGH, nutrient hydrogel, and scalp matrix have safety results documented in stand alone individual component studies. We, ourselves, and our research team members have sponsored over a dozen pre-clinical studies and over 100 patient clinical trial cases with stem cells or bioelectric stimulation or SDF-1. We sponsored over $7 million in pre-clinical studies looking at the safety and efficacy of SDF-1 alone working with the Cleveland Clinic and the University of Florida and teams in the Netherlands. Based on this data our team led the effort that led to the first ever FDA authorization for a combination gene (SDF-1) and cell therapy clinical trial for organ regeneration (heart) in 2009, the REGEN trial. We also sponsored the first repeat delivery organ regeneration muscle stem cell large animal pre-clinical study in Spain that was published in 2010.
We are utilizing natural bioelectric signals at very low voltages that we understand to be the natural signals the brain uses to get DNA of cells to release specific proteins for specific regeneration purposes on demand.
When you scrape your knee or elbow your brain gets an injury signal and then sends back a bioelectric signal to get SDF-1 to start releasing at the injury site. This SDF-1 is a stem cell homing signal that seeps out and is picked up by stem cells in the patient’s bone marrow that then release from the bone marrow and migrate to the injury site. Once enough stem cells sufficient to grow back the lost knee or elbow skin tissue from the scrape have assembled at the injury site the brain gets a starvation signal and then reverses the polarity of the signal and drops the voltage further and moves from the recruitment and proliferation mode to the differentiation (building new tissue) mode. In this phase your knee or elbow skin tissue is regenerated. What we are doing with our technology is playing back those natural signals on demand. If we point our bioelectric signal to your knee your brain/body thinks your knee has been scraped. All of the signals and composition components we use are the natural regeneration components found in your body that handle repairs everyday. For these reasons we are confident our safety studies will come out well as well as our efficacy studies.
FT: I notice you have a full ensemble of regenerative medicine tech companies in development using bioelectric stimulation. Can you tell us a bit about what you find so attractive about this technology and some of the successes you have seen from using it?
Howard: We, I, have invested everything, ALL we earned from all our previous inventions into this combination organ regeneration technology because we fully believe in it.
Dr. Miller: Our approach is totally new. There are others that are working in electrical stimulation, but none have been in the field as long as Dr Leonhardt, and none have worked on developing a technology to have the ability to individually target specific proteins and the sequence of those stimuli. In addition, no one has developed the combination of very beneficial agents to bolster the benefit of the bioelectrical stimulation. In short, we believe that we have developed the most novel, comprehensive, and science-based strategy to treat not only hair growth, but many other common medical problems.
FT: Is there anything else you’d like to mention about the HairCell technology and your current progress moving forward?
Howard: We are bringing 31 years of un-paralleled research into this development. In the 1980’s we introduced the leading predictably compliant cardiovascular balloon catheters. In the 1990s we developed that which is today the leading non-surgical system for repairing aortic aneurysms and the first percutaneous heart valve. In 1999 we launched the first stem cell company for heart repair. Our treated patients improved 95.7 meters in exercise capacity testing over randomized placebo control patients. We are more confident about the combination of bioelectric regeneration signaling + micro infusion pump delivery of the fifteen component regeneration composition for organ regeneration, including hair, than we have ever been with any device or therapy we have developed before.
Dr. Miller: We have developed an approach that is both non-invasive and simple to deliver, and yet is perhaps the most advanced multi-component system ever tested in hair growth. It will be very well tolerated and show improvement in a relatively short period of time. Importantly, we have an escalating regimen that can employ the use of stem cells for those with the most difficult conditions. We will move quickly from the initial group of 30 patients to a much larger pivotal trial that will lead to FDA approval for commercialization. The study will start very soon and we are confident that it will enroll very quickly as hair loss is such an important problem for thousands of men and women.
FT: Thank you Howard and Dr. Miller for taking the time to speak to us.
Wow, things just got real, huh? I’m fascinated by the potential of using the body’s own natural electrical signaling to stimulate organ regeneration. I look forward to the results from HairCell’s animal studies and the human pilot study in 2017.
When Howard was responding to my questions for the interview he provided many citations to scientific documentation about his research in regenerative medicine, his patents, and articles on the components of the HairCell composition. I decided that it would work best to have all of that information listed separately so I’ve listed many of the citations here for your perusing interests.
Howard J Leonhardt’s Patents
Article on Google’s parent company investing in bioelectric medicine
Scientific article on stem cell homing factor (SDF-1)
Scientific article on bioelectric stimulation and regeneration
Scientific article on IGF-1 and hair growth
One of Howard’s earliest stem cell delivery patents
A pivotal study for SDF-1 and nutrient hydrogel that was sponsored by Howard
The REGEN trial of 2009 – First approved gene-modified stem cell therapy trial
Updated on September 2, 2016
Welcome to another edition of Weekly Thoughts. This week’s news consists of an update on Christiano’s cellular hair growth startup Rapunzel, some interesting tidbits on Histogen, and updates being made to the Ultimate Guide to Hair Regeneration 2016. Bonus news alert: I will also have an exclusive interview with one of the newer hair growth startups coming next week, stay tuned for that one. Before we get right into the news items I’d like to share with you all a website that a reader of this site named Beth has made in her own efforts to support new effective hair growth treatments coming to be. Please visit her site Hair Growth Campaign. Thank you all for your continued support. Read More
Posted on July 22, 2016
Replicel’s hair growth therapy, RCH-01, has officially received approval by Japanese regulatory authorities to be used in a clinical trial that is now launching. We did hear some rumblings recently that Shiseido was putting the final touches on it’s clinical trial to take place at the Tokyo Medical University Hospital and Toho University Ohasi Medical Center. Now it’s official. Have at it Shiseido, and best wishes from Follicle Thought.
Updated on September 2, 2016
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. Read More
Updated on July 24, 2016
Hey everybody and welcome to another installment of Weekly Thoughts.
This week we get an encouraging update about the logistics of Shiseido’s trial and more information about the RiverTown Therapeutics compound.
Shiseido Closer to Trial
News was finally released this week about the upcoming trial that Shiseido will be conducting in Japan for Replicel’s RCH-01 therapy. Shiseido acquired an exclusive license in 2013 to bring Replicel’s hair regeneration therapy to market for Asian countries. Since then, it was known that Shiseido would be implementing it’s own clinical trials of RCH-01 in Japan which would bring RCH-01 to market much sooner than the US clinical trial timelime. Many had thought that Shiseido’s trial would commence in 1st half 2016, but that was not the case. It appears that Shisiedo is finally ready to commence it’s trial in Japan which would be the only trial necessary to bring the therapy to market, as long as the therapy showed efficacy/safety initially and maintained safety after the duration of the trial. Read More