Update: March 6, 2020
Reader “John Doe” just discovered this new study from Shiseido. I am assuming that they are using both Replicel’s technology as well as their own-in house technology. Lead author is Dr. Ryoji Tsuboi. The treatment entails autologous cell–based therapy using dermal sheath cup (DSC) cells. Both male pattern hair loss and female pattern hair loss patients were treated. 50 males and 15 females, all between the ages of 33-64.
The positive: Total hair density and cumulative hair diameter at injection site increased at 6-months and at 9-months in all patients. However, later text suggests that hair count increased or remained the same in all patients (i.e., did not decrease in anyone).
The negative (possibly): The “positive effect was temporary until 9 months”. This statement does not make sense, and is likely a translation issue? Are they actually trying to say that hair growth started to decline 9 months after injection? In any case, we should prepare for an eventuality where we need once-a-year DSC injections. Hopefully, Shiseido succeeds in rapidly commercializing this autologous hair growth treatment in regulation friendly Japan.
Update: November 26, 2019
Shiseido Japanese Patent Published
Someone named “Paul” (thanks!) just posted a link to Shiseido’s official Japanese patent, which was released in Japan in May 2019. Paul found this link on an investing forum, and he also posted a bunch of information about stock prices. I deleted the latter, as I do not want to encourage blog readers to buy or sell Shiseido or Replicel stock.
Ultimately, whether “Shiseido decides to do so OR not to do so” will decide everything. The patent indicates optimism about the technology. However, nothing is set in stone for sure. The English translation of the patent is extremely informative if you expand each section and wait for it to load. Or you can open the whole Japanese pdf too and use translation software.
The big question I have is what portion of the technology comes from Replicel (licensing), versus from Shiseido in-house?
The inventors are listed as:
- Tsutomu Soma
- Jiro Kishimoto
- Sayaka Koide
- Hitoshi Okochi
- Masahiro Kiso
Update: November 26, 2019
Replicel Year-End 2019 Update
RepliCel released its 2019 year-end update today. It includes discussion about its partnership with Shiseido. Regarding Replicel’s cellular therapy (RCH-01) for androgenetic alopecia, the key points are that:
- Shiseido’s clinical study in Japan is now complete.
- Shiseido will soon announce on whether it will commercially launch the product in Japan or conduct further clinical testing.
- Replicel is holding off on Shiseido’s final decision before pursuing any further Phase 2 trials. The former’s Phase 1 trials in Europe were successful.
- The Replicel and Shiseido dispute is still unresolved.
It seems like Shiseido could still launch the product in Japan soon. No doubt aided by the country’s new faster regulations for marketing when it comes to cellular therapy.
Replicel’s proprietary injection device, RCI-02, is on schedule to get approval and be used in much of the developed world in 2020.
March 23, 2019
I used to cover Replicel (Canada) and its Japanese cosmetics behemoth partner Shiseido at least a few times per year until last year. At some point, I got skeptical about the RCH-01 autologous cell therapy hair loss product being released any time in the near future.
Besides typical delays, Replicel and Shiseido had some unclear conflicts regarding their partnership.
However, Replicel published two important updates this month, the second of which is of most interest to us:
- Update 1 (March 5, 2019).
- Update 2 (March 19, 2019).
Per the first link above, the disagreement regarding the agreement between Shiseido and Replicel remains unresolved. However, it is not subject to any litigation or arbitration at this time.
The key money quote is from the second link:
“While the Company’s RCH-01 product for hair loss due to androgenic alopecia may be launched in Japan much earlier if Shiseido decides to do so, current planning anticipates the potential for all four products to be on the market in Japan by 2022.”
The implication seems to be that:
- Shiseido could release the product well before 2022. See my past post on the company’s new research facility in Kobe, Japan.
- Even if Shiseido does not release the product earlier, it will quite possibly get released in 2022 in Japan by Replicel.
See my past post on Japan’s new laws fast-tracking stem cell therapies and clinical trials.
Another key quote:
“Unlike anywhere else in the world, one well-designed cell therapy trial in Japan, approved by their regulatory authorities, has the potential to lead to product market launch.”
Replicel is clearly focusing on a “First-in-Japan” strategy due the country’s favorable regulatory environment. Shiseido has rights to the Asian market when it comes to RCH-01. However, it seems like Replicel can still release the product in Japan in 2022 if Shiseido does not do so?
Hard to make this conclusion for certain without knowing much more about the two companies’ legal contract. In any case, this is a great development.
— A discussion of Replicel’s technology in two videos.
— Shseido and Adenosine for hair loss.
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