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/Replicel – Replicel’s hair growth treatment, RCH-01, involves culturing a person’s own hair follicle cells and then re-injecting them back into their scalp. First, a small punch-biopsy is removed from a person’s healthy hair follicles. Then a specific cell is dissected from the follicle and cultured in a growth medium. The cells are replicated into the millions and then injected back into the person’s scalp. There is a short video about the procedure here. Replicel has been involved in a lot of activity over the past years 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 it’s 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 it’s 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. The product has been refined over the past few years to contain less cellular impurities and be a more concentrated formula of growth factors compared to it’s initial inception.
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 1A 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. Follica – Known 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. Follicum – Follicum 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. Samumed – SM04554 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 begun it’s 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 2016.
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: Initiating proof of concept study at any moment as of September 22, 2015
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.
13. The University of Berlin Team – The three main players that we know about from the German team are Dr. Roland Lauster, Dr. Gerd Lindner, and Dr. Beren Atac. Their body of work is extensive, including the development of hair follicles outside the body using stem cells. More recently, Dr. Atac presented their work on 3-D micro hair follicle culturing. It seems as though they have been at the forefront of cutting-edge hair follicle research while flying under the radar.
Points of Interest: These scientists have been growing hair follicles in test tubes pre-2010. The internet found out at the 8th World Congress for Hair Research that these researchers have been busy over the past couple years and their development is accelerating. They are potentially “right there” in terms of being able to create an unlimited amount of hair follicle regeneration.
Status: Research still being conducted in the lab.
14. Sanford-Burnham Medical Research Institute – The technology being developed at SBMRI by Dr. Alexey Terskikh is based on turning human IPSC (induced pluipotent stem cells) into Dermal Papillae-like cells to induce hair growth. The technology would then be applied through scalp injection. Dr. Terskikh and his team showed up unexpectedly in news headlines in early 2015. Their arrival was most welcome to the hair regeneration enthusiasts. The SBMRI technology is similar in nature to Replicel and the research done by Dr. Xu of UPenn, but the SBMRI technology seems to contain a missing piece of the puzzle which makes it that much more exciting.
Points of Interest: This method could potentially produce an unlimited amount of hair growth cells (DP cells) for hair restoration purposes. The SBMRI is actively promoting this research, and have even announced they are “looking for business partners to commercial this discovery.”
Status: Preclinical stage
15. Theracell (TC-CT-12131) – Theracell’s hair regeneration technology is an injectable DPSCs (dermal papilla stem cells) treatment. Like Replicel, the cells are harvested from about 10-20 healthy hair follicles from the back of the scalp. The DPSCs are then isolated from the follicles and cultured for several weeks. Theracell refers to the cells after being cultured as “pre-follicular units.” The pre-follicular units are then re-injected back into the scalp where the person desires to grow more hair. Cool. Theracell is very new to the game and there is little information online about the people involved or what stage they are at in their development. From their webpage I’ve learned that they are based in the UK and have a subsidiary in Greece. I wonder which doctor’s research they are involved with.
Points of Interest: Theracell’s process involves 3D culturing for the dermal papilla stem cells, according to their webpage. Anyone who has been following hair regeneration for the past couple years knows that successful 3D culturing has been thought to be perhaps the missing piece for unlimited hair regrowth. The information on their website about their technology sounds very robust.
Status: Preclinical stage