Update: Epibiotech CEO Sung (who is the author of the new paper covered in this post) is answering our questions in the comments this week. Please note that English is not his first language.
Earlier this month, Epibiotech CEO Jong-Hyuk Sung published a detailed new paper titled “Effective and economical cell therapy for hair regeneration.” It was widely covered in South Korean media (h/t “Theo”, who also sent me this update on Mr. Sung’s presentation covering the paper). They call him Seong Jong-Hyeok in that article.
My interest piqued when I read such a thorough scientific paper from a CEO (almost unheard of in this industry). I showed it to a well known hair transplant doctor, and he found it to be a great summary. I also e-mailed one of Epibiotech’s media representatives with some questions, but no response so far.
Adipose, Dermal Papilla and Dermal Sheath Cells
Note that Dr. Sung has publiched numerous papers on adipose-derived stem cells (ADSC) and hair regeneration (and wound healing) for 15 years. This CEO seems to be a scientist first and foremost, rather than a business person.
This latest paper covers the three main types of cell based hair regeneration treatment strategies that are currently being developed:
- Adipose-derived stem cells (ADSC or ASC).
- Dermal papilla cells (DPC).
- Dermal papilla epithelial cup cells, better kown as dermal sheath cup cells (DPSC or DSC).
The paper also mentions the manufacturing of hair organoids using induced pluripotent stem cells. Including a shout out to Dr. Takashi Tsuji.
- Note that Shiseido (including its use of Replicel’s technology) is working on a hair regeneration treatment involving culturing of dermal sheath cup cells. More details here.
- Also note that in the past, Aderans and Intercytex both saw some success in hair growth via dermal papilla cell culturing and injection into balding scalps. HairClone is currently trying something similar.
Dr. Sung’s company Epibiotech is ultimately driven by “Off-the-shelf” allogeneic DPC therapy. It aims to begin Phase 1 clinical trials for its EPI-001 dermal papilla cell hair multiplication treatment in 2023. We are all hopeful that things will move faster in Asia in comparison to the US or Western Europe. The company can already mass-produce dermal papilla cells with hair growth ability using spheroid culture, hypoxic conditions, and growth factors.
Adipose Derived Stem Cells
Given the author’s background, the paper is especially detailed when it comes to ADSC (ASC). Dr. Sung highlights the pros and cons.
- Adipose-derived stem cells are easy to access and isolate in large quantities. This is not true when it comes to dermal papilla cells and dermal sheath cup cells.
- While ASCs promote hair growth through the paracrine effect, they have a poor potential in hair neogenesis. Dr. Sung suggests further development in methods to enhance the trichogenecity of ASCs.
Other New Studies on Hair Regeneration
As if this was not enough, two new papers on hair regenearation came out in the past month.
- A lierature review from Japan coveres numerous cell therapies for hair regrowth. This includes mesenchymal stem cell (MSC) implantation. Adult sources of MSC include: adipose tissue (including SVF); bone marrow; DPC; DSC; placenta and umbilical cord. The paper also analyzes non-cell therapies, including exosomes, extracellular matrix, platelet-rich plasma, and the MSC secretome. The last mentioned “comprises bioactive materials, such as growth factors, cytokines and nucleic acids that play an important role in regulating the hair follicle cycle and regeneration”.
- A new study from China on microenvironmental reprogramming of human dermal papilla cells for hair follicle tissue engineering.
- And finally, a recent video on regenerative medicine for hair loss starring Dr. Jerry Cooley (interviewed by Dr. Robert Haber).
It’s Stemson therapeutic, epicbiotech,histogene and dnovo let’s see who makes it alive to 2030 !… I honestly see elon musk conducting his own organ cloning research on mars before any of these companies come to the market . I can’t believe stemson therapeutic is still a long ways to conducting human trial! neurolink is going to start human trials in January of 2023. When neurolink comes out no one will care much about hair loss anymore neurolink will change everything.
Good news. The Epibiotech CEO is willing to answer reader questions. Please only post intelligent ones (technical ones if you have the understanding) and I will forward to him.
Thanx Admin. Would his technique works even on people who have been bald for decades? Would it work even if the pili muscle hasn’t been working for years (regardless whether you are completely bald or not)?
Thanx!
You don’t need that muscle at all for hair growth, Dr. Paus has a presentation on that topic.
yet some people on here seems to think it is necessary???
i’d like to hear the answer rather from a professionnal that from a reader, other studies say otherwise…
MoA for dermal papilla cell (DPC) treatment is primarily paracrine effet, which will transit telogen hair to anagen hair or increase thickness of hair follicle. DPC is very effctive in Pig
DPCs alone may bot induced new hair follicle in vivo.
MoA for dermal papilla cell (DPC) treatment is primarily paracrine effet, which will transit telogen hair to anagen hair or increase thickness of hair follicle. DPC is very effctive in Pig
DPCs alone may bot induced new hair follicle in vivo.
I don’t think that DPC is as effective as hair implantation in severe hair loss patients.
Instead it may be effective mild alopecia patients because DPC alone could not make new hair.
Clinical trial will be 3~4 stage of Norwood scale (or Hamilton-Norwood scale)
what in mild alopecia patient who have been stable for 20 years ??? no loss but no regrowth ?
what make the difference between a sever alopcia case or a mild one in term of the ability to grow new hair ?
Phenomenal work, admin. Let’s seize the opportunity. Shot from the hip some quick questions:
* Are there still 4/5 product candidates?
1) autologous DP-cells (EPI-001)
2) autologous DP-cells with gene enhancement DKK (EPI-007)
3) antibody (EPI-005)
4) RIPK-inhibitor (EPI-002)
5) allogenic “off the shelf”
* What is the timeline to market for each of these candidates? What’s the expected efficacy of each of these candidates?
* How do your 4 cell-type approaches apply to your pipline?
1. Adipose-derived stem cells (ADSC or ASC).
2. Dermal papilla cells (DPC).
3. Dermal papilla epithelial cup cells, better kown as dermal sheath cup cells (DPSC or DSC).
4. IPSCs for allogenic solution
* How do the Korean laws simplify the trial process and which candidates of Epibiotech are affected by those laws?
* When are trials starting for each product? How long do you expect the trial duration to be? Effects must be seen immediately, do you have to observe for longer? How many participants are planned for the first trials?
* Will Epibiotech be the company to market all these products or are they marketed by other companies? Maybe transplant surgeons?
* Are all therapies scalable? What’s Humedix role? The demand will be huge!
* Are you thinking of offering the services to foreign customers in Korea? Or offer it in other countries too?
* How many employees does Epibiotech have?
* Are you thinking of therapies for grey hair?
* Any idea about the prices for the therapies? You claim that it will be below traditional hair transplants?
* Updates on your cooperation with C&AI, Linkedin Bio, Pharos and Biofab? Still running?
* Is funding an issue?
* Are you aware of the competition on the market? HopeMed, Fukuda, Stemson, Hairclone, Olix, Kintor, etc.
* Epibiotech’s overview on the website is confusing, would be great to make it more understandable.
Thanks! I hope he will answer at least half :-)
Hey Ben, it is the actual CEO Mr. Sung, but he told me there were too many questions. He will answer some more soon. There might also be a cultural or translation issue whence he moved on to the single question comments.
I’ll answer two question
* Are you thinking of therapies for grey hair?
–> No, only focused on hair regeneration
* Any idea about the prices for the therapies?
–> 1000~2000USD for DPC allo, but DPC auto may be expensive
Honestly if it costs 2k just for one session I can just farm a bit more and go for a transplant… rather than wasting 2k every 3 – 6 months…
Hi again, I would appreciate it if you could ask him if they recruit foreigners into the Phase 1 trial too and when they estimate a release.
sorry, may be impossible
These are great questions above.
I would simply want to know which product is he most confident in. What success does he expect from that product.
DPC therapy and antibody
I also got a question if it still fits in:
How long would the effect of the treatment be expected to last?
Is the plan for it to be a one-time and done treatment or will it have to repeat every few years or so?
(I’m sorry if my question has been answered in the linked papers/past already but I couldn’t find it anywhere)
DPC is effectiv more than 3 months after single dose in Pig.
Therfore, may effectiv efor 6~12 months in human.
DPC therapy every year?? How is this sustainable if there is no banking of follicle (follicle banking is expensive)
We have GMP fercilities, and cultured DPCs can be storaged for future.
In addition, we will try allogenic transplantation
Hi admin, i have a question.
Will the DP cell therapy turn dht sensitive HF to non DHT sensitive?
We injected human DPCs to male pig, and effective for more than 3 months.
However, I did not think that DP cell therapy turn dht sensitive HF to non DHT sensitive
Okay , thank you for answering my questions. Let’s c what happens in the clinical trial. It wreid that DPC cells from the donor region don’t retain their property when they are injected to a balding area.
I agree. What’s the point otherwise?
He said the reverse. He does not think that DHT sensitive HF turn non-DHT sensitive. i.e., frontal hair do not become like donor hair.
Ohhhh!! Thanks for posting Admin. Huge difference obviously:)
I am confused, is this already actual Mr. Sung answering the questions?
His comments all have a Korean IP address so I approved, but am now a bit skeptical. Just checked my site’s e-mail account and no message from Dr. Sung telling me that he is commenting. Have notified him.
My questions are does Epibiotech already working on bioprinted human hair follicles in 3D/4D in vitro culture or therapies using iPSCs and what obstacles they have so far?
Also, are they familiar that other companies already tried therapies using dermal papilla cells, but their results were very limited. Why they believe their technology will work better than others?
We are planning to 3D print DPC and ORS cells to make hair.
I think we have a method to increase hair inductivity of DPCs, and it is different form other company.
@Bryan I was giving you props for asking the best questions, but admin censored my positive message!
My main question is whether clinical trials can be done faster in South Korea (as is the case in Japan).
https://www.hairlosscure2020.com/japans-new-laws-to-fast-track-stem-cell-therapies-benefitting-shiseido/
Will begin P1 clinical trial next year
Question. If “Big Pharma” really is preventing a cure from hitting the market, what’s the point in getting excited for any new treatments?
DPC injection will last over 6~12 months, and have little adverse effects
Dr. Sung, does Epibiotech already working on bioprinting human hair follicles and what obstacles do you have so far?
Do you think that DPC injections has very limited success, because other companies went through same way, but with very limited success? Why do you think that with Epibiotech will be different story?
Thanks.
Preprint of new Fukuda and Kageyama paper Relevant to the subject matter of this post.
https://www.researchsquare.com/article/rs-2263496/v1
Dr. Sung, thanks for the the answers.
I know that there is no ’one size fits all’, but do you think that bioprinting/bioengineering human hair follicles in in-vitro/de-novo culture is ultimate solutions for most people on, because in theory should be bring unlimited supply of hair follicles for transplantation?
So, does that mean that you are already in advanced phase of creating technology of 3D print of DPC and ORS, and do you think that this technology will bring solution for hair loss?
And last question. Dr. Tsuji 2 years ago successed in creating bioengineered hair (https://www.nature.com/articles/s41598-020-80624-3), and Dr. Junji Fukuda in last report successed in creating fully mature hair follicles in cultures with almost 100% efficacy from mouse stem cells for the first time (https://www.science.org/doi/10.1126/sciadv.add4603), and also Chinese team showed successful regeneration of hair follicles and other skin appendages at 4 weeks after in situ bioprinting (https://www.sciencedirect.com/science/article/abs/pii/S2772950822004046?via%3Dihub), so does that mean that Epibiotech technology will have totally different approach compare to other companies/labs?
Dr. Sung, I have couple of questions.
I know that there is no ’one size fits all’, but do you think that bioprinting/bioengineering human hair follicles in in-vitro/de-novo culture is ultimate solutions for most people on, because in theory should be bring unlimited supply of hair follicles for transplantation?
So, does that mean that you are already in advanced phase of creating technology of 3D print of DPC and ORS, and do you think that this technology will bring solution for hair loss?
And last question. Dr. Tsuji 2 years ago successed in creating bioengineered hair (https://www.nature.com/articles/s41598-020-80624-3), and Dr. Junji Fukuda in last report successed in creating fully mature hair follicles in cultures with almost 100% efficacy from mouse stem cells for the first time (https://www.science.org/doi/10.1126/sciadv.add4603), and also Chinese team showed successful regeneration of hair follicles and other skin appendages at 4 weeks after in situ bioprinting (https://www.sciencedirect.com/science/article/abs/pii/S2772950822004046?via%3Dihub), so does that mean that Epibiotech technology will have totally different approach compare to other companies/labs?
Dr. Sung, this is my last question.
Mark Skylar – Scott’s lab shared their last paper that they successfully created technology and process for large-scale production of wholly cellular bioinks via the optimization of Human Induced Pluripotent Stem Cell aggregate culture in automated bioreactors:
https://onlinelibrary.wiley.com/doi/10.1002/adhm.202201138
What is your real prediction. When bioengineering human hair follicles can be reality in future? How far is Epibiotech from creating bioengineered hair follicle and put it in clinical practise?
@Bryan I love you bro . you articulated my questions in a way better way than I can ever do! . hopefully the Good Dr answers them !
Dermal papilla therapies with injections are pointless. They have very short and limited effect. I don’t know why companies still push it.
I don’t know single person that will go 2 times per year to get injections for 2K per session. For that amount of money he can get decent hair transplantation and move on with life.
Another failure treatment.
No-one seems satisfied with just 1 hair transplant. Usually most people get 2. And I suspect that many get 3 over the course of 20 years. So total lifetime cost could be $50,000 plus if you go to a reputable surgeon in any developed country. Even some of the top surgeons in poorer countries are now charging similar rates.
If this treatment guarantees maintaintenance of existing hair and even modest regrowth, I would go for 2x a year if available in the US.
You would be surprised at how many people get PRP treatment 2 or more times a year. What makes you conclude “not a single person” etc…?
No sh*t Admin, Bryan speak for yourself. Hair transplants aside, if I could drop oral and topical remedies for something equal or better with a couple three treatments a year, sign me up!
This. Also, you’d be surprised how thin your sides get over time. There simply isn’t enough to pull from after a few surgeries and age (and I’m sorry to say, while the transplanted hair “may” not fall out, the rest of it will. Hence multiple surgeries). People don’t realize how thin the sides get with one surgery. Noticeably thinner. And then there’s less to pull from.
HTs aren’t the answer. Maybe if you’re young but as time goes on you lose more hair, your sides them thinner and it just sucks. Most of the people saying just get an HT know very little about them. Go talk to people that had them. First ten years are great then the rest of your hair falls off it (because minox is not gonna stop it).
Now, if you could clone your hair and get 5k transplants, multiple, that might work.
As one gets older, and the balder they get, hair transplants won’t be the answer. I know several people with thinning sides where docs have told them they can’t do much, if anything. If you’re nearly fully bald 3k won’t do sh*t for your head. In fact i know a guy that had 3k done – very little coverage on his shiny head. And yes it was an excellent doc. You’d need a heck of a lot more than that and with thin sides it simply won’t work.
My point is – HTs aren’t the answer for a large majority (and not just due to the cost).
@Bryan exactly!
For cloning they have to extract X amount of donor hair and then multiply Y amount of DPCs. If we have to do this treatment every 3/6 months we need more donor hair in the future. DP cell therapy got the hype because it was theorised to be fairly permanent (~2 years),now going by the replicel results and Dr Sung’s comment it is clear that the effectiveness is for short term. So for that price its a PRP that really works or a exosome treatment that really works. It’s wreid that the effectiveness is for short term because after multiple DP cell injection the native DPCs should take up the property of donor hair (at least in theory) . Having said all this, its a a pure speculation now and i hope they pass the ph1 and show us great results.
Unfortunately I have to agree with the notorious trolls in this forum.
I am not convinced of a 2/3/4-times a year treatment for 2000 each. But how about once and then avoid future loss with one of the newer androgen-oriented treatment?
I lost the overview on all candidates of Epibiotech, but the DKK-DP-treatment is apparently the more permanent solution than EPI-001. The organoid-tech would be a full solution like Fukuda or Stemson, but that’s probably far away. And then the very promising antibody…
Anyhow, given recent revolutionary developments (HopeMed, Amplifica, Kintor) there might be much less demand for transplants and cell-based treatments. Timewise they’re all on the same level more or less.
Hey Ben, i am not a troll. Joke aside, what is dkk-Dp treatment? Never heard about this. Could you please elaborate/ELI5?
Kintor releases more news today:
Kintor Pharma Reaches Favorable Endpoint in Phase II Alopecia Drug Study for Women
Here’s the link:
https://finance.yahoo.com/news/kintor-pharma-announced-primary-endpoint-113000913.html
New interview from Epibiotech:
http://m.yakup.com/news/index.html?mode=view&cat=12&nid=278412
Thanks. Theo also emailed me this yesterday so I updated the main Epibiotech post (republished on home page).
Hello, so does this mean that the treatment this company is going to provide us with isn’t permanent? I mean, will we still need maintenance sessions? Also Isn’t hair multiplication/ hair cloning supposed to be a permanent solution (one-time treatment) for baldness?
Admin please reply.
Thank You!
From Spain in August 2023:
Hair follicle neogenesis with wild adult human follicle dermal papilla cells (hFDPc) using fibrin microgels. An important step in the pursuit of human hair follicle regeneration therapies.
https://onlinelibrary.wiley.com/doi/10.1111/cpr.13528