View Full Version : (not hair) First therapy that undergo the new Japan law (phase 1 to commercialization

10-05-2015, 12:31 PM
hey guys, not hair related but infact it could be

"Mesoblast and Japanese company JCR Pharmaceuticals announced approval of Temcell (allogeneic mesenchymal stromal cell-based product) in pediatric acute GVHD in Japan. This is the first product to be approved under the Japanese “regenerative medicine law” that allows cell therapy treatment to go from a phase 1 directly to commercialization.


TEMCELLŽ HS Inj., the first allogeneic regenerative medicine product in Japan for intravenous infusion, is isolated and expanded mesenchymal stem cells (MSCs) derived from bone marrow aspirate of healthy adult donors. It is an innovative therapy in view
of utilizing the MSCs’ properties to treat the disease."

First I like the fact that it is confirming that the temp approval occured at the end of phase1 /beginning of phase 2.

Second the allogeneic MSCs derived from bone marrow they are using in this approved treatment, could maybe also lead to a hair therapy :

Treatment of MSCs with Wnt1a-conditioned medium activates DP cells and promotes hair follicle regrowth

Our study reveals that BM-MSC-generated Wnt1a promotes the DP's ability to induce hair cycling and regeneration.

29 jun 2015

Wnt-CM was prepared from the supernatant of Wnt1a-expressing bone marrow mesenchymal stem cells (BM-MSCs) that maintain the hair-inducing gene expression of DP cells.

The results demonstrate that Wnt-CM can maintain the hair induction ability of DP cells in expansion cultures, and this approach can be used for large-scale preparation of CCS cells in vitro to treat hair loss

So the problem with aderans kind of treatment, is that during cultivation and expansion of DP cells, they lose their hair induction capacity
Here above they show that this can be solved when cultivated with bone marrow derived MSCs

But I read in another study that the amount of MSCs-BM they can take from one individual is not sufficient to make a therapy. That's why that first treatment that has been approved under temp app is interesting, cause they use allogeneic MSCs. So this mean no more amount of MSCs problem

DP induction is solved, if 'Allogeneic MSCs' is solving the MSCs amount problem, then a therapy like they suggest in the 2 studies could come out of that
a treatment that would consist of cultivation of DP cells with allogeneic MSCs-BM is an aderans 2.0 kind of treatment, that don't have the iPSCs current issues

let's see how the TEMCELL product goes in japan, and maybe i'll try also to contact those chinese researchers or their institute in those 2 studies, cause maybe they are already testing their method in human or planning trials

10-05-2015, 03:41 PM
Lacazette, thanks again for your finding. So new Japan laws enable the companies to commercialise the treatment after phase 1? I thought, that it is possible only after phase 2 (that's why Shiseido has to conduct their phase 2)? It would be great if you could try to contact them and ask about using this method for treating hairloss.

10-05-2015, 03:58 PM
One very good thing about the new law in effect means shiseido could do deals with any companies with relevant patents and technology to really bring about a magic cure within the decade or 2.

10-05-2015, 04:24 PM
Hey, lacazette, where have you been?? Thanks for your findings, keep posting! :)

10-06-2015, 04:16 AM
Hey Luiza, yes I kindy disappear :D I was quite busy and made a little break about all hairloss related things, I'll post again now what i see ;)

hey Arieux, I think in legal terms, sisheido could have that safety temp app, but simply they don't go for it cause replicel protocol is not efficient and ready, that's why they talk about transfer technologies and its ameliorations between the two I think. The protocol of sisheido won't be just the replicel thing with DSCs imo, but more a phase 2 with a 2.0 protocol. ( that would be considered as a phase 1 if the protocol is really different)
Dr Manabu Ohyama is the licensing partner of replicel and is the leader of shiseido hair research center, and worked for more than 3 years on growing hair with iPSCs, so shiseido is preparing a real cure no doubt about that
Also Sisheido don't need money like little biotechs, so wouldn't take the risk to commercialize a simple replicel protocol with just 'probable efficiency', and if there was efficiency, poor efficiency, it would make bad publicity for them to see clients paid for an ineffective thing
Unlike little biotechs, I think Shiseido will go for temp approval only when they'll have a protocol that garanteed efficiency after a phase, and I don't think the simple replicel treatment with DSCs is sufficient for what they want. Replicel only is definitly not a cure, just a good addon in a bigger strategy I think

And i'm quite sure of that cause Dr Manabu Ohyama os Shiseido is a big deal, when you look again the japan tv show (with subtitles) , https://www.youtube.com/watch?v=-p0Hvrx093I

the first 7 min is on tsuji and his bioenginerred follicles, and the rest is Dr Ohyama who use iPSCs to grow hair (at that time he was like jahoda with half of the job done and only missing the other part, what Terskish's have found since, so things have moved on then for him

i'm not sure but didn't dr Ohyama will be at the world congress for Shiseido? I think i saw it somewhere

10-06-2015, 05:24 AM
This is amazing work tbf Lacazette. You seem to be able to connect the dots between all the researches and what we seem to miss.

10-06-2015, 05:34 AM
Lacazette, thank you for your explication. And yes, dr Ohyama will be present at this congress, he is co-director of stem cells section.

And lol you are lucky that you could just ,,make a break about hairloss related things''. I have un impression that I don't think about it only when I sleep...

10-06-2015, 09:39 AM
lol in fact I was like that too until this summer, when I saw enough amount of progress and saw that things are moving well in what is missing, so for the waiting time, I try to accept my baldy destiny and try to not think about it everyday and moved on as I can. As a diffuse high norwood, I can't hide anything, so I buzz it to 0, and it helps to not see hair everywhere or look in the mirror think about how bad the haircut looks. I let grow some beard, and well it's not that bad, I'm lucky that the shaven look don't make me look like elephantman , but inside of me I hate that viking look lol and I definitly don't live my life at 100% and the same that if I had hair, as you can see my break didn't last long^^ but well at least I can have little breaks in my mind now unlike before hehe though I would be in big depression if there wasn't more than 10 competitors for the cure, the japan regenerative medecine law, and the recent major progress on iPSCs safety, 3D bioprinting, etc. Now im sure that my problem will be solved, it's helping to relax, but the other problem is when, and i have to managed to live the most 'normally' I can during this shitty waiting game :d