Stemore (EpiBiotech): New Cell Therapy Company Interview
In this article we will take a look at the pipeline of Stemore, a new company based in Korea that is developing a wide range of hair loss treatments.
Stemore was founded in 2015 by Jong Hyuk Sung, Professor of Pharmacy at Yonsei University in South Korea. Sung is an accomplished researcher and has authored over 75 published studies. One particular research paper published by Sung elicited an unexpected response which compelled Sung to pursue endeavors beyond academia. When Sung’s 2015 paper on hair growth was published, he received many inquiries from members of the public who were seeking better solutions for hair loss. Luckily, Sung listened to these pleas for help and decided to establish Stemore in order to commercialize the hair growth discoveries he was making in his laboratory.
The main focus of Stemore is creating cell-based hair growth therapies. The company is currently developing several interesting cell types which you will read about more in the interview below. Sung was also recently quoted to say “Stemore’s technology is to maintain its (hair growth) capacity even after culturing the dermal papilla cells several times.” A statement like that will surely catch a lot of people’s attention. Without further ado, please enjoy this highly technical and detailed interview with the Stemore company.
Interview With Stemore’s Director of Research Nahyun Choi PhD
FT: What lead to the inception of the company Stemore?
Stemore: Our early research was focused on adipose-derived stem cells (ASCs). Early on, we established a technology to isolate and culture ASCs from fat tissue, and then started research using ASCs as their hair growth effects became known. However, animal testing has shown that ASCs themselves do not have much hair growth effect. Then, years of research have shown that pre-treatment of various factors in ASCs increases the ASCs motility and significantly increases the hair growth effect. The stimulators of ASCs used by our group are as follows: vitamin-c, low-dose UV-B, platelet derived growth factor-D (PGDF-D), LL-37, and commercial drug such as minoxidil, and udenafil. Of potential stimulators tested, PDGF-D exhibited the strongest effects on ASCs and increased secretion of growth factors via mitogen-activated protein kinase (MAPK) pathways. In addition, LL-37 increased the secretion of growth factors and the hair-regenerative efficacy of ASCs via early growth response 1 (ERG1) protein and the MAPK pathway. ASCs also secrete multiple growth factors such as vascular endothelial growth factor (VEGF) and basic fibroblast growth factors (bFGF), that can increase the proliferation of DPC (dermal papilla cells). The pre-treated ASCs secrete a variety of growth factors, and the paracrin effect of these growth factors increases the hair growth stimulating DPC or ORS cells (outer root sheath cells).
Previous studies have processed and studied many stimulators to enhance the function of ASCs. However, no other factor has increased the ability of ASCs to regenerate hair follicles. Hair follicle regeneration is a technology that can regenerate new follicles by receiving factors that can grow hair follicle from cells that function as so-called stem cell niche. It is widely known that DPC function as hair follicle stem cell niche. In fact, if you take a three-dimensional culture of DPC and ASCs, and you do a hair follicle-regeneration test, ASCs have little or no hair follicles, whereas the DPC have new hair follicles.
So, we became interested in the study of the differentiation of ASCs into DPC. ASCs have much less hair regeneration potential and hair growth rate than DPC, but they have advantages of having little self-immune reaction, being able to mass-extract and easy to culture. On the other hand, DPC has high hair regeneration potential and hair growth rate. However, the amount of DPC that can be made from scalp samples with a certain area is smaller than you think, and hair regeneration potential of DPC can be significantly reduced at passage 7. So, from the 6~7 passage in fact, we can no longer use DPC. This disadvantage is followed by many cost-effective problems in commercializing DPC itself. Because 2 ~3 passage was passed to increase the number of DPC in the laboratory, in fact, it takes an enormous amount of cells from the beginning to use DPC in the early passage, where hair follicle regeneration potential is high. In order to overcome the weakness of each of ASCs and DPC, a new differentiation technology into DPC from ASCs were developed and published in Journal dermatological science. In this study, we named DPC pseudo-cells made from ASCs as tfASC. We are working hard to overcome the fatal drawbacks of this study. tfASC has significantly lower hair follicle regeneration than DPC and has not regenerated hair sheath conclusively.
Stemore Pipeline
FT: I notice a vast pipeline of therapies on the Stemore website. Can you please describe briefly what these treatments are in the pipeline? Are they all classified as drugs or will some be cosmetics?
Stemore: Among the materials in the pipeline of the homepage, SM-DPC, SM-Plus, SM-tfASC, and SM-P2 are currently being developed with interest. In addition, there is marliolide that is not currently in the homepage and we will summarize as follows.
(1) SM-DPC
The dermal papilla comprises the specialized mesenchymal cells at the base of the hair follicle, and some of the dermal papilla cells (Sox2-positive) have the function of stem cells, which play a key role in hair growth and maintenance of the hair cycle. It is possible to treat hair loss by supplying a sufficient amount of healthy dermal papilla cells. DPC have better hair regeneration effect than adult stem cells, however, it is difficult to get enough cell number for cell therapy and commercialization due to long culture period (6 ~ 8 weeks). Stemore has secured a source technology for mass culturing of DPC: three patents have been filed for this technology (KR10-2018-0023990, KR10-2018-0102202, KR10-2018-0051872). Hypoxia improves hair inductivity of DPC via nuclear NADPH Oxidase 4-mediated reactive oxygen species generation: Article was published at British journal of dermatology / publicized in major media in February, 2019 (image from study below).
Stemore’s cultivation technology prevents aging of DPC and can dramatically reduce the incubation period and production cost during production. SM-DPC maintains hair inductivity at 8 ~ 9 passage compared to conventional culture methods.
(2) SM-plus
According to previous papers, hair inductivity of ASCs is significantly lower than that of DPC (Poor capability of 3D-cultured adipose-derived stem cells to induce hair follicles in contrast to 3D-cultured dermal papilla Cells, Seo et al., 2017). Development of preconditioning method to increase the hair growth ability of ASCs is needed. Stemore, Inc. has more than 20 patents and SCI papers for various pretreatment methods as mentioned in the above first question. Among them, technologies related to activation of ASCs by PDGF-D are registered in Korean and US patents (Korean Patent Registration 10-1686229, US Patent Registration US9,994,824), and are published at Stem Cells journal, which is one of the top journal in stem cell research area (Functional regulation of adipose-derived stem cells by PDGF-D 2015.02). Related technologies were reported in the 2015 Daily Newsaper, Major Daily NewsSpaper.2015, and KBS ‘Jang Young-sil Show’ in October 2016.
Stemore has established optimal ASCs culture conditions using growth factors that promote the growth of ASCs through studies on ASCs function enhancement for more than 5 years. Serum-free medium for cell therapy clinical trials was developed, enabling adipose stem cell preconditioning optimized for hair loss. Activated ASCs induce mouse hair growth (anagen) and significantly increase the length of mouse vibrissae compared to stem cell treatment alone. Nonclinical toxicity studies on SM-plus1 and SM-plus2 optimized for combination therapy will begin in late 2019 and will apply for an IND for clinical trials by the end of 2020.
(3) SM-tfASC
Previous studies demonstrated that ASCs can promote hair growth, but unmet needs exist for enhancing ASC hair inductivity. Therefore, we introduced three trichogenic factors platelet-derived growth factor-A, SOX2, and β-catenin to ASCs (tfASCs) and evaluated whether tfASCs have similar characteristics as DPC. tfASC cell size is smaller than that of ASCs, and they exhibit short doubling time. tfASCs also resist aging and can be expanded until passage 12. Cell proportion in S and G2/M increases in tfASCs, and tfASCs express high mRNA levels of cell cycler lated genes. The mRNA expression of DP markers was notably higher in tfASCs. Moreover, NGS analysis revealed that the global gene expression of tfASCs is similar to that of DPC. The injection of tfASCs accelerated the telogen-to-anagen transition and conditioned medium of tfASCs increased the anagen phase of vibrissal hair follicles. Finally, we found Collectively, these results indicate that 1) tfASCs have similar characteristics as DPC, 2) tfASCs have enhanced hair-regenerative potential compared with ASCs, and 3) tfASCs even at late passage can make new hair follicles in a hair reconstitution assay. Because DPC are difficult to isolate/expand and ASCs have low hair inductivity, tfASCs and tfASC-CM are clinically good candidates for hair regeneration. SM-tfASC is currently in the process of preparing for development.
FT: When do you expect the first cosmetic/quasi-drug products to become available by Stemore?
Stemore: We plan to release functional cosmetics by 2020 based on materials that have hair growth effect under development. Currently, the materials to be added to the pipeline are marliolide and SM-P2. Marliolide is a natural product having g-lactone ring with a,b-unsaturated carbonyl group, which was firstly isolated from the leaves of Mollinedia marliae and the bark of Cinnamomum cambodianum. Recently, marliolide has been shown to act as an NRF2 activator. The method for synthesis of marliolide has been developed and marliolide derivatives have been synthesized. Marliolide, like minoxidil, can stimulate hair growth in murine model. Currently we are analyzing the mechanism by which marliolide promotes hair growth. In addition, we’ve obtained a patent on a phytoestrogen ingredient extracted from Vietnamese plants. The method for synthesis of SM-P2, one of the phytoestrogens, has been developed and is currently developing a process to increase the amount of synthesis. It is considered to have less side effects compared to existing products. After the establishment of mass synthesis method, it will be developed as a cosmetic or pharmaceutical material. Mechanism studies have shown that it activates the estrogen receptor-a, inhibits the 5a-reductase, and has a hair growth effect equivalent to minoxidil (2% MNX) in topical animal experiments. We are planning to release female-type functional hair cosmetics using these two materials, however these products will also be available to men. We also aim to complete the development of DPC-based cell therapy by 2022.
FT: At this time are there any industry partners working with Stemore to commercialize a product?
Stemore: Currently, we have five PhDs in life sciences and several master’s degree talents working for the pipeline development. We plan to steadily increase the number of PhDs from 15 to 20 by 2022. We are developing our own pipeline and plan to commercialize it. Our current goal is to develop Stemore into Asia’s No. 1 hair follicle lab by 2022 and will achieve IPO by 2023. Currently, there are several companies in contact, but if there is any company that is interested in us, we hope you will contact us anytime.
Posted in Baldness Cure, Hair Growth Treatment, Stemore
Some highlights: a cosmetic 5a-reductase inhibitor cosmetic planned for the market in 2020 and a novel DP cell therapy entering clinical trials in 2020.
If there are further questions about Stemore’s pipeline and strategy I may ask a representative of Stemore to answer questions in this thread.
sorry, but i don’t understand: 5a-reductase inhibitor cosmetic planned for the market in 2020 it is postponed? Stemore said “We plan to release functional cosmetics by 2020 based on materials that have hair growth effect under development” – this means that these cosmetics will not be released in 2020?
Drago, the SM-P2 phytoestrogen has been shown to inhibit 5a-reductase and the company plans to release SM-P2 by the end of 2020. There’s been no mention of a postponement so far, I’m not sure where you saw that.
Do they plan on releasing any studies or picture that show efficacy? And do they know which quarter they plan on releasing this by?
I’m sure there will be some data released with the product. At this point I am not sure which quarter the cosmetic product will be released in. Q3 is a safe estimate for now.
New stuff, thank you! It sounds like this Stemore knows what they are doing in stem cell lines. Phase 1 trial for cells already next year is actually best news.
I tend to trust the companies that show some initiative to get things done. I hope that they can come through and make something to reach us patients.
So are these people doing something similar to Shiseido?
Interesting,
So they too are going for the DP cell approach, just trying to culture them in a different way.
I wonder if Hairclone have got a solution to the difficulty of culturing alot of cells without losing inductivity.
I remember Paul Kemp saying previously that it would take 8 weeks to culture the cells ready to be injected
It would be something similar to Shiseido or HairClone. But they also have something different such as their hybrid DP/Adipose cells. They’re also working on techniques to enhance the viability of the cells after being multiplied several times.
TissUse Update
TissUse is still moving right towards their trial which is first in line among next gen hair cloning companies (as far is known in the public). I just heard from their CEO this week again whom you’ve created your commentor name after.
If the neopapilla works as planned, people are going to be very surprised and appreciative. Before we know it, trial will be commencing.
This sounds like good news. I’m not getting excited about TissUse yet but I feel good that they’re proceeding straight to the trial. Hopefully their solution will be natural and permanent – I guess we’ll see in serval months of the trial’s progress. Thx for the update.
So, will we get an article when the trial starts, or we have to wait few months nevertheless? Thank you very much admin, i think things in general are going in the right way?
Unless the company decides otherwise, which I don’t expect at this time, there will be an article announcement when the trial starts.
Jong Hyuk Sung is professor on Yonsei University which is number 5 university on list of top 10 universities in South Korea. In country with very advanced science and technology. So, he is very credible and educated person.
Can you ask him do he knows Tsuji and what he thinks about their procedure? Do they have intentions in future to try similar method for hair cloning?
Market in 2028 at best.
At best the DP cell therapy could be on the market in 2025.
Thank you for keeping the stream of hope alive
I think this is one of the more promising companies on the horizon, if anything its great backup to shiseido, hairclone, etc. If they indeed figured out a way to preserve the potency of dp cells after a few culturing times then its amazing, we could just inject our scalps (or let doctors do it) until the break of dawn. Fingers crossed here
Do you think im 2020, could we knoe if these treatments work? I mean this one, tsuji’s and shiseido’s. Not talking about commercialising, just about knowing if they do work. Bc if that is the case, it would just be a matter of time right?
We will definitely know if TissUse works in 2020.
Stemore will do a phase 1 trial and we will get a look at their efficacy but I know Stemore would continue to refine their therapy if need be since they are at the very beginning.
We will also know definitely in 2020 is Shiseido is a go/no.
We may find out if Tsuji works in 2020, but there is no word on that yet.
This company has many treatments in their pipeline, that is exciting. It seems indeed that the combination of new treatments coming will bolster the options that we have to sustain our hair.
How is it going for DHT-resistant hair follicles?
Have not heard anything from them lately.
Will there be an official announcement of J hewitt that trials begin in January 2020?
Do You have any new informations of Jon Knight?
I don’t know if J Hewitt will put out a press release at the beginning of the trial but it is likely or he could put out a statement through this blog. There’s no new information except things are moving forward as planned. There was a slight delay due to working out the logistics with the third party company who will be conducing the advanced cell culturing method for the trial.
Hi Admin, could you maybe do more articles in Exosomes? There are now so many companies already offering this Treatment. I wonder if all the many Pharma Companies doing Stemcell Research also work on Solutions with Exosomes?
What do you think about offers like tjis? …
https://www.stemsential.com/services/hair-regrowth
Hi Admin, one more Company on Exosomes … Treatment EXOCURE
https://exo-defytime.bio/exosome.html
Sorry to Spam you with Exosomes … this will be the last for now 🙂
https://nextlevelregeneration.com/product-service-info/
John, thanks for sharing about the exosomes. This is a new interesting topic that is getting some discussion online and at conferences. I just have a slight apprehension to the treatment because I have not seen any results that appear better than PRP yet and exosomes seem to be 1-2x more expensive then PRP currently. There has also been 2 readers of this site who told me they had the treatment done and did not experience any significant gains. The reader experience comments are the most significant to me at this time. So, while it’s still a new interesting procedure I’d like to take time to see what kind of feedback and results come from the clinics who are offering this treatment. Though, I may do an article on exosomes early next year.
Good call Admin, I had PRP/CRP done ( 4 rounds within a year, with little to nothing to show for it) by a very reputable hairloss doc in the field that’s moved on to exosomes. I would’ve taken a chance despite the treatment being in excess of $5k but they never seem to be able to provide concrete, measurable results. I’m sure there are some people that these treatments have some level of benefit for. However my own conclusion is that it’s not many or much.
if results where great they’d release but i think its not good news
Yoshi, if Shiseido does not release any results in 2020 it would be equivalent to releasing results that showed no improvement. Them or Replicel would not allow such time to go by. One way or another we will get an answer and the matter will be cleared up in 2020. This is my point, I never said we would see the results, I said we would definitely know if Shiseido is going to come out or not. Please stop trolling and have a nice day 🙂
I wasn’t sure about the Admin at first, however I’ve concluded that the he’s a fair arbiter of comments. You didn’t see the comments, neither did I, my guess is that this Yoshi cat stepped over the line besides just doubting the treatments effectiveness or viability. Admin, I’ve said it befroe, you are one patient guy! 🙂
The comment was not deleted because it doubted RCH-01, I don’t mind at all if he doubts RCH-01 at this point, he made insulting comments that went beyond whether RCH-01 was going to come out this year.
For example your comment continues to muddy the waters with your claim “it seems like often times when someone doubts a treatment, even with good reason like in the case of RCH-01, you delete their comment.” You have no way to justify your statement and you don’t read the comments to be able to opine whether they are appropriate or not, right? In regards to treatment comments, I do not delete comments that are civil and add to the conversation even if they are doubting a treatment. But just adding garbage to a thread has no point and thus it does not help anything, it just makes an environment less enjoyable. The bottom line is people are often emotional when it comes to treatments and their effectiveness/release dates, I get it and I can relate, nonetheless sometimes the comments are unwarranted.
I appreciate you Yoda for your good support and fair comments about treatments/companies. I enjoy most all comments and participation the comment threads! In this line of work patience is required 🙂
Some people are never satisfied or happy, even when they get this wonderful service for free. I appreciate the follicle thought site because it gives me info on treatments that I don’t find coverage elsewhere. I am surprised some will still complain. Like you say some ppl will take their own sorrow or frustration out on other. I know you have not promised us about these treatments but you make sure to give us the best information that is available at the moment. Then at the end of the day we hope that these treatments will come out and be effective for us all. We want to know what is coming so we come here.
I agree. I appreciate the updates. Thank you….always!!! 🙂
Liz
Thanks Liz! I appreciate your continued support.
It’s obvious that we will know by the end of 2020 if Shiseido is going to work or not, I wonder why anyone would ever argue with that. the trial was supposed to complete in 2018, it lasted a little longer and by the end of 2019 results are not out yet. One way or the other we will know in 2020 if the product works. Replicel will not let the questioning go on further than that, no one would allow them to.
Question for Admin, or anyone else who wants to answer:
When it comes to potential treatments that are promising, what are your Top Three? Tsuji? Exosomes? RCH-01?
Hi Paul, I hope more people chime in with their top 3 as well but my current top three are TissUse, Tsuji, and Hairclone. The reasoning is: TissUse/J.Hewitt is the first next generation treatment to have publicly announced a human trial beginning early next year, I give Tsuji the second place because his technology is revered and his company is based in Japan, thus a human trial could be completed quickly, and Hairclone is at #3 because they also have a regulatory advantage in the UK by being able to provide the treatment to physicians immediately after they have a MHRA licensed facility to produce the cell cultures in. As an aside, unless there is a potential for exosome related treatments to be tweaked and really improved upon I don’t feel they’re in the conversation of new promising treatments, I think they’re in the category of PRP, still worthwhile but not groundbreaking.
Admin, stemson is not on your list? I know they have a ways to go (like 4-5 years or so) but don’t they have good backing and doesn’t their technology seem promising?
I was told that Hairclone are expecting to be in a position to start treating people in Q2 2020.
Why do they then state on their website the its still 2/3 years away?
http://hairclone.me/hair-cloning/
They are developing two ‘treatments’;
1) is follicle rejuvenation where they are injecting cultured DP cells to rebuild miniaturising follicles back into terminal hairs.
2) actually creating new follicles for implantation.
When I met with Dr. Farjo the MD of Hairclone a few weeks ago he told me that they hope to be able to offer the DP injections (1) in the first half of next year.
IMO as it stands, they are the closest.
Obviously nothing is guaranteed.
They do also need to update their website as some of the info is out of date.
That is great to hear!
Do you maybe know anything about whether it is possible to get the treatment if you are not from the UK?
It will be possible Tom to be get the treatment if you are not from the UK, however the treatment will have to take place in the UK from a physician who is partnered with HairClone. For now the Farjo Clinic is known to be a leading partner for HairClone treatments but there will be others that I’m sure will be listed on the HairClone website as the treatment gets closer to availability.
Matt / Admin,
Is there any way to get in touch with Hairclone or Dr Farjo or Paul Kemp? I’d like to ask them some questions. Politely, of course.
I went on the Hairclone’s website, but I couldn’t see any contact details.
The email for HairClone is paul@hairclone.me
According to Paul 2020 is possible, but 2021 is more likely. I emailed him
I have no idea, but how you define Top 3 matters. Most hair growth? Ability to keep current? Soonest to market?
In my opinion the one’s mentioned by Admin are not soonest to market, if they are ever materialize at all. As far as I know they haven’t run any clinical trials on humans but are hoping for a fast track to market. This is IF they are proven to to be effective. I’d bank more near term on Samumed, Follica and CB. Not saying they are definitely coming to market but at least they have gone thru clinical trials and are in or near stage III.
Hairclone won’t need to go through clinical trials to begin treating people under the UKs ‘specials’ provision.
I’m not an expert but ok, possibly not formal clinical trials. However my sentence above still applies: “This is IF they are proven to to be effective”. It seems that many hair loss posters get way ahead of their skis and assume these treatments are guaranteed to come to market. I’m not saying they will or won’t (but like you hoping they do) just that until they do they ain’t a slam dunk.
Yes the effectiveness is still yet to be determined.
If their results are as good as or better than some of the previous topline results from Aderans it would be great treatment.
Hopefully the way in which they plan to culture the DP cells in 3D which greatly improve the inductive power of the cells will achieve these kind of results.
The key advantage with HC is they can make iterative adjustments and improvements to their treatment as they learn what works.
They can do this without going through trials.
I spent some time contacting Hairclone where they told me that they would send me information about the whole process, a few days ago I sent the last email to Cheryl. I don’t understand how they were in a kind and attentive beginning and then total silence….
I hope you will announce some news soon, but the truth is that I was disappointed.
Soul,
Thats rather disheartening,
Who were you originally emailing?
I know for instance that Cheryl works for the Farjo institute and is maybe not actually employed by Hairclone. Although Dr. Farjo is the MD of Hairclone and his practice is undertaking the follice extraction for the banking service, there is a clear distinction to made regarding the two institutions. I was speaking with a member of staff there asking questions and they obviously know about what Hairclone is and are involved with the banking side but are not involved with the other aspects so couldn’t answer many questions.
What were you asking?
Thanks, Admin. What stage are Hairclone at?
Dave, I suppose I meant the ones you are most excited about. The ones that are the most promising. The ones that, rightly or wrongly, you are pinning your hopes on. A dangerous game, I know. But isn’t that why we are all here? For hope?
Personally, I’m not too excited about Follica, since it could well be a glorified combination of derma rolling and minox. Unless that treatment produces significant, noticeable results, it sounds like lots of hassle for minimal improvement. Early days, of course.
Yoda, is Samumed a topical for your scalp? What is CB?
Hi Admin, is this something promising?
http://www.legacyhealthcare.ch/pipeline.html
What did Jon Knight said which date in Januar the SHT – trial will start? And what did he say how long this trial will last? Until which month?
Mustafa thanks for the question, he’s not putting out dates at this point. Projects like these require special preparation and coordinating with the original scientists to come and teach the method to the company who will be carrying out the trial, etc. There are a lot of variables at work here including variables on the side of the company who is contracted to carry out the trial. Things are continuing to move forward, but know that Jon Knight most likely will not put out a statement every time there is a minor delay for some insignificant reason. I want to wait a little bit before I ask him another round of questions, but I do think the question you posed “how long does this trial last?” is a good one. I will ask him next time I get in touch with him. The trial is getting closer everyday.
Admin,
If SHT works ideally and it can rejuvenate dead follicles and grow new ones, could someone then get a transplant to restore a receded hairline or crown and then use SHT to maintain the remaining native hairs? That would be the ideal scenario for me. Maybe even RCH-01 could do the same?
Yes Big L if SHT works as hoped one could use an FUE to create a strong hairline and then use SHT to maintain existing hairs with it. This has been an hypothesis that many people have been waiting to try. If RCH-01 works it could help maintain hair as well. I think the general consensus is that SHT should have a better chance at creating significant growth than RCH.
Thanks Admin! Yes the question „how long the trial will last?“ is very important
Any update regarding their cosmetic products being released sometime this year? Are they delayed due to covid-19?
Dimitri, there should be an update from this company within the next month. I will be able to get their latest timelines when the update is given.