Category Archives: Dermal Sheath Cup Cells

Shiseido Phase 3 Trial Results

I have covered Japanese cosmetics behemoth Shiseido for almost ten years across over a dozen posts. My last post about them became too confusing, as I was regularly appending it with brief new updates. I was awaiting the correct time to restart. This company also makes the popular Shiseido Adenovital Shampoo.

Shiseido’s work on a hair loss cure based on the injection of cultured autologous dermal sheath cup cells (DSCs) is promising and safe. While the company has no problems with fundraising, thay have had some issues with their partnership with Replicel (Canada). I will not repeat that story here, but readers can check out my past posts on those two companies for more details.

Shiseido Dermal Sheath Cup Cell Hair Growth.
Shiseido’s hair growth treatment with the injection of autologous dermal sheath cup cells. Includes work from Replicel.

Shiseido Phase III Study Results Published

Earlier this month, Shiseido released the results of its “Phase III equivalent” study. The actual work was published in “The Journal Of Dermatology” Volume 50, Issue 10, in December 2023. In that same second link above, it also says “First published: 26 September 2023”, which might mean date of original Japanese submission.

No-one seems to have noticed it on Reddit as far as I can tell. I only learnt about it due to someone e-mailing me and asking me to check the end of the first PubMed link above where it says: “Grants and funding: Shiseido Group.”

It is not surprising that this development went through without notice. For one, the title of the paper does not even mention Shiseido’s name:

“Efficacy of autologous dermal sheath cup cell transplantation in male and female pattern hair loss”.

Even causing more confusion is the fact that they call this a “Phase III equivalent clinical study.” And only 36 volunteers participated in this trial. Not even remotely close to what you expect in a proper large-sized Phase 3 trial. The Shiseido website’s Hair Regenerative Medicine page has no new updates either.

In any event, this is clearly Shiseido’s trial for its DSC injections. After culturing dermal sheath cup cells (the source of dermal papilla cells) from the scalp skin of the hair loss patient, they are implanted (injected) into the same patient’s balding scalp skin to rejuvenate damaged hair follicles and promote healthy hair growth.

Among the paper’s many co-authors are the renowned Shiseido-affiliated Dr. Ryoji Tsuboi and Dr. Manabu Ohyama. All of the co-authors are also associated with at least one of the folllowing four entities in Japan:

  1. Department of Dermatology, Tokyo Medical University, Tokyo.
  2. Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo.
  3. Department of Dermatology, Toho University Ohashi Medical Center, Tokyo,.
  4. Regenerative Medicine Research & Business. Development Department, Yokohama.


Keeping in mind the small size of the study, the results while positive, are a bit underwhelming. Thirty-six male and female participants with pattern hair loss (PHL) were injected with dermal sheath cup cells. These DSCs were harvested from non-affected occipital hair follicles twice in quarterly intervals.

On global photographic assessment, 30% of the participants showed improvement.

The phototricogram data analysis showed increases in the:

  • Cumulative hair diameter of 107.6 ± 152.6 μm/cm2. This was a +1.4% increase versus baseline.
  • Hair cross-sectional area of 3069.1 ± 10960.7 μm2 /cm2. This was a +3.4% increase versus baseline.
  • Mean hair diameter of 0.9 ± 0.9 μm. This was a +2.2% increase versus baseline.

The female and high terminal hair ratio groups achieved better outcomes. It is not clear if any new hair growth occurred from the above breakouts. But stronger and denser existing hair after 12  months is a positive. And could imply better future protection against dihydrotestosterone (DHT) spurred follicle miniaturization.

Another confusing statement:

Of the total participants, 62.9% noted some degree of improvement.

It seems like this 62.9% figure is based on patient feedback rather than any kind of measurement. And per the math, this would imply that 22 of 35 patients gave a positive response, while 1 dropped out before the 1-year mark.

I have not tried to find any long version of this report, as overall it leaves much to be desired. I hope a far lengthier Phase 3 clinical trial is still going on.

And I also hope that Shiseido will be able to remain fully transparent, in spite of any pending legal issues with Replicel.

Effective Cell Therapy for Hair Regeneration

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:

  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).

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.

Cell Therapy Hair Growth
Cell therapy for hair growth. Adipose, dermal papilla and dermal sheath cup cells. Source: Biomedicine & Pharmacotherapy, January 2023.

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).