Replicel Is On Fire Lately — Data In Feb.

[Armando Jose]

Where are the images, if any?, that the method works.

 

[Throwaway94]

Where are the images, if any?, that the method works.

They are in the article. The results weren't cosmetically significant either way though.

 

[That Guy]

No your opinion was based on unrealistic expectations. "Omg it didn't turn a NW5 in a NW1, Such a fail bro!"

Mine is based on reality.

"We are very pleased that the data from this randomized, placebo-controlled, double-blinded, dose-ranging clinical study of 65 patients (male and female) with pattern hair loss confirms, with statistical significance, the observations from our ph 1 trial in a larger cohort of patients including females, a wide variety of ages and hair loss, and compared with a placebo-control. In summary, the study produced a statistically significant and clinically meaningful increase in hair density and diameter as measured nine months after treatment,” stated RepliCel’s Chief Medical Officer, Dr. Rolf Hoffman.

Btw, shiseido updated their site in february this year, let's look what they say:

In recent years, technology has evolved remarkably, particularly in the development of digital technology and various devices that are greatly changing our lives. We apply these technological trends using our strengths to offer personalization and e-commerce counseling which allow customers to choose the skincare and makeup items that suit them without going to a store.
We also pursue hair regenerative medicine and create new beauty solutions that support skin health and beauty from the inside through food.

https://corp.shiseido.com/en/rd/development/

Now let's read the conclusions of the actual new study:

https://www.sciencedirect.com/science/article/abs/pii/S0190962220302723

Conclusion
The results suggest that cell therapy with autologous DSC cells may be useful as a new therapeutic method for treating MPHL and FPHL.


"Bu..bu it's not coming out bro, they couldn't regrow a NW5 to NW1! Complete failure bro!"

Strawman. Go through this thread. We have also already been over how RepliCel sucking off investors is not "evidence. You're also forgetting this is in Shiseido's hands; what RepliCel says literally matters not.

I have also never said, nor expected, this to restore any norwoods.

I expect it to do what the initial study showed it could do: Maintain existing hair after one treatment.

The Japanese have failed to reproduce prolonged results as good as phase 1.

 

[That Guy]

9 months of maintenance is good imo

Yes...in your opinion.

Objectively, however, 9 months after a biopsy when more-permanent, cheaper, no-biopsy-required options exist is crap. Especially given that they do not have the infrastructure to keep the cells indefinitely and even if they did, the cost of the treatment would then shoot up astronomically.

and despite what you want to believe, no one is going to pay thousands of dollars every nine months out of paranoia of finasteride.

everyone wished it would be 2 years or longer but that was not realistic tbh.

Except it was realistic because phase 1 showed sustained results after FIVE YEARS.

Fuuuck man

So far Shiseido is still in the game and nothing shows they won't commercialize it unlike you were saying

Logic, market history, etc. tells us they won't.

this will be the future of hairloss treatment.

Lol

 

[topicalthunder]

The results give maintenance, yes, but it won’t be commercialised. Not enough of a market for maintenance, be honest to yourself.

Without substantial regrowth they won’t even get the investments needed to make this a reality. Shareholders want big money makers, not obscure maintenance treatments that only a very small fraction of people will be able to even afford and use.

 

[topicalthunder]

Didn't know we had so many business analysts here, lol.

There are still too many unknown variables to draw any conclusions. But untill now, your "analysis" is nothing more than conjecture and RCH is still in development by Shiseido

Exactly, at the current time it is not a viable treatment. You said it yourself.

 

[Hairismylife]

I haven't given up all hopes in them. Maybe they will find a way to maximize regrowth in their last trail, who knows? But massive regrowth of several Norwood is only achievable by hair cloning, I think RCH could only give you one to two Norwood at best.

 

[That Guy]

Lol if you really believed this would give 5 years of maintenance

Yeah, I believed they'd be able to at least repeat the results of phase 1. Crazy, right?

Instead, they failed to even do that, which is the research equivalent of a "bruh" moment.

Not enough of a market for maintenance, be honest to yourself.

To be fair, if this was capable of the indefinite maintenance that phase 1 suggested and was offered at the previously-suggested price of ~1000 and paired with hair transplants and such, it would probably do well.

Sadly, that doesn't appear to be in the cards.

Because we don't know all of the information.

We know enough

 

[MrClean1]

They could apply to commercialize right now in Japan. Why don't they do that? Why perform another phase II trial? Because this one failed.

This doesn't work or doesn't work well. Just move on, i have seen this movie about 20 times and it always ends the same.

 

[Hairismylife]

For the idiots who still think Shiseido will drop RCH after this study...wel you're wrong.

Updated (3/12/20) Shiseido Plans To Pursue RCH-01
Directly from Shiseido’s “New Research” webpage regarding the RCH-01 therapy:

“Safety level and improvement effects were confirmed in a clinical study conducted by Tokyo Medical University from 2016 to 2019 using our autologous cell culture processing technology. A further clinical study aiming at practical application will be conducted in the future.”

https://www.folliclethought.com/shiseido-releases-rch-01-trial-results-2020/

Future…I hope within 2 years.

 

[topicalthunder]

For the idiots who still think Shiseido will drop RCH after this study...wel you're wrong.

Updated (3/12/20) Shiseido Plans To Pursue RCH-01
Directly from Shiseido’s “New Research” webpage regarding the RCH-01 therapy:

“Safety level and improvement effects were confirmed in a clinical study conducted by Tokyo Medical University from 2016 to 2019 using our autologous cell culture processing technology. A further clinical study aiming at practical application will be conducted in the future.”

https://www.folliclethought.com/shiseido-releases-rch-01-trial-results-2020/

Never said they will drop it, just said at the current time it is not good enough to warrant a release. No point expecting a miracle when it comes to hair loss.

Also, to add to this, it seems they are going to be using their new patented RCI-02 dermal injector device, this makes things easier and should hopefully increase efficacy. It supposedly provides an “improved level of control and accuracy” when administering these types of injections.

 

[MeDK]

They could apply to commercialize right now in Japan. Why don't they do that? Why perform another phase II trial? Because this one failed.

If they commercialise it now, then they have to commit to that method to do the treatment. Remember that commercialising in Japan is a "phase 3" so they can't just all of suddenly change treatment, and what about those who paid for the lesser effective treatment?

If they believe there is a bigger potential to be achieved then they will try and go for that. No need to release something that puts their development on the treatment for a hold for 3 years or more because of a premature market release.

Replicel still have unanswered questions about the efficiency and method, then its more wise to do a phase 2 again than doing a market release that makes no sense.

We have to remember they still worked on the single treatment method, and they haven't explored the multiple treatments method yet. Which might be their next goal in trails.

 

[MeDK]

Never said they will drop it, just said at the current time it is not good enough to warrant a release. No point expecting a miracle when it comes to hair loss.

Also, to add to this, it seems they are going to be using their new patented RCI-02 dermal injector device, this makes things easier and should hopefully increase efficacy. It supposedly provides an “improved level of control and accuracy” when administering these types of injections.

Yes the RCI-02 is a part of their outside japan clinical trails, which was stated some years ago. That they wouldn't continue any clinical trials them self before a commercial release of the RCI-02. And now that it is soon underway, we might we some faster development.

 

[Throwaway94]

Never said they will drop it, just said at the current time it is not good enough to warrant a release. No point expecting a miracle when it comes to hair loss.

Also, to add to this, it seems they are going to be using their new patented RCI-02 dermal injector device, this makes things easier and should hopefully increase efficacy. It supposedly provides an “improved level of control and accuracy” when administering these types of injections.

The RCI-02 is not Shiseido's to trial with. Last I heard they were developing something similar on their own.

 

[Spanishboy97]

Even exoxomes probably yield better results than this

 

[doflamingo]

Its 2020, we still dont have shiiiiiiiiet , its straight to the ugly nameless balding cuck secondary character for you it seems. Cope and find ways to enjoy your bald lives

 

[itsjustsimon]

Its 2020, we still dont have shiiiiiiiiet , its straight to the ugly nameless balding cuck secondary character for you it seems. Cope and find ways to enjoy your bald lives

CB _maybe_ before 2023, 5 years later _maybe_ Follica. Sorry bro. Been saying this for quite some time.

RCH has been a disappointment in the first round of clinical studies and we know this for quite some time. Why people expected miracles from this drug is beyond me.

Replicel is a shitty startup and the only miracle to me is that it still lives. Get over it.

 

[max310]

12% bwahaha

camel piss grows more hair than this.

they most likely play with dildos in the lab.

nerdy faggots and their fat mouth. Just keep it shut!.

ahh boring!.

 

[MeDK]

Well here are some future plans from Replicel from their managerment update

Within 12-24 months:

• Announce data from a clinical study of the dermal injector (though this will likely not be required for regulatory approval, it will be valuable for marketing purposes)
• Announce clinical data from a skin rejuvenation clinical study in Japan
• Announce plans for the commercial launch of the skin rejuvenation treatment in Japan
• Obtain Japanese regulatory approval to market launch the dermal injector product line in Japan
• Announce a Japanese partnership for commercial distribution of the dermal injector product line in Japan
• Announce a partnership to fund a next-phase hair regeneration study in a select market

Secondary emphasis was placed on the following initiatives:

• Clarifying Shiseido’s plans for RCH-01 in Japan and Asia;

• Preparing for phase 2 studies of products outside Asia (as funding permits). <-- could also be RCH-01, since the Dermal injector gets EU CE-approval (as far as i know always been replicel own condition to continue phase 2 for RCH-01)

While we are not as far along in some of our programs as we had anticipated we would be at this point in 2020 given the unanticipated impacts of the global pandemic, over the past 12 months we've announced:

• positive clinical data from the Japanese hair-regrowth study which was published in the esteemed JAAD, Journal of the American Academy of Dermatology. To have a paper accepted by such a publication highlights the unique efficacy and potential of RCH-01 as well as Shiseido’s ongoing commitment to the product;

Below is a brief synopsis of the status and next steps of RepliCel’s programs:

RepliCel Dermal Injector (RCI-02) Product Line – The manufacturing of RepliCel’s initial batch of commercial-grade dermal injectors and related consumables was materially impacted by pandemic-related shutdowns and supply-chain disruptions. Production is still recovering and we await delivery of the first units to commence the functional testing needed to produce the data required as part of the CE mark approval application.

New European regulations have impacted the testing and commercialization requirements. We continue to work with regulators to determine precisely how this will affect the timing of our commercial launch timelines but a launch is now expected to slip into early 2021.

Discussions with potential regional distributors and global partners (outside of Greater China which is licensed to YOFOTO) are currently underway.

Hair Regrowth RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 human clinical trial in Europe and a successful dose-finding human clinical study in Japan. Shiseido has announced its intent to conduct further development and clinical testing of the product in Asia examining, in particular, the impact of a series of injections in the area of thinning hair. Once the RCI-02 injectors and consumables are available for clinical studies, RepliCel will begin preparations for phase 2 human clinical trial of this product outside of Asia (Shiseido’s licensed territory) examining both dose and injection frequency for the treatment of hair loss. Early stage discussions with potential partners outside of Asia are currently underway.

Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido its expectation that (a) they deliver to RepliCel the full clinical data set from the recently completed study of RCH-01 in Japan and (b) confirm that their license agreement remains intact without breach. RepliCel reserves the right to take the position that Shiseido’s failure to deliver the clinical data from the recently completed clinical study in Shiseido’s Territory constitutes a material breach of contract which, failing a cure, will warrant RepliCel’s termination of the agreement and revocation of Shiseido’s license resulting in RepliCel’s freedom to license the RCH-01 technology to competitors in Asia.

 

[ZP31]

Well here are some future plans from Replicel from their managerment update

Within 12-24 months:

• Announce data from a clinical study of the dermal injector (though this will likely not be required for regulatory approval, it will be valuable for marketing purposes)
• Announce clinical data from a skin rejuvenation clinical study in Japan
• Announce plans for the commercial launch of the skin rejuvenation treatment in Japan
• Obtain Japanese regulatory approval to market launch the dermal injector product line in Japan
• Announce a Japanese partnership for commercial distribution of the dermal injector product line in Japan
• Announce a partnership to fund a next-phase hair regeneration study in a select market

Secondary emphasis was placed on the following initiatives:

• Clarifying Shiseido’s plans for RCH-01 in Japan and Asia;

• Preparing for phase 2 studies of products outside Asia (as funding permits). <-- could also be RCH-01, since the Dermal injector gets EU CE-approval (as far as i know always been replicel own condition to continue phase 2 for RCH-01)

While we are not as far along in some of our programs as we had anticipated we would be at this point in 2020 given the unanticipated impacts of the global pandemic, over the past 12 months we've announced:

• 
  
  
  • positive clinical data from the Japanese hair-regrowth study which was published in the esteemed JAAD, Journal of the American Academy of Dermatology. To have a paper accepted by such a publication highlights the unique efficacy and potential of RCH-01 as well as Shiseido’s ongoing commitment to the product;

Below is a brief synopsis of the status and next steps of RepliCel’s programs:

RepliCel Dermal Injector (RCI-02) Product Line – The manufacturing of RepliCel’s initial batch of commercial-grade dermal injectors and related consumables was materially impacted by pandemic-related shutdowns and supply-chain disruptions. Production is still recovering and we await delivery of the first units to commence the functional testing needed to produce the data required as part of the CE mark approval application.

New European regulations have impacted the testing and commercialization requirements. We continue to work with regulators to determine precisely how this will affect the timing of our commercial launch timelines but a launch is now expected to slip into early 2021.

Discussions with potential regional distributors and global partners (outside of Greater China which is licensed to YOFOTO) are currently underway.

Hair Regrowth RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 human clinical trial in Europe and a successful dose-finding human clinical study in Japan. Shiseido has announced its intent to conduct further development and clinical testing of the product in Asia examining, in particular, the impact of a series of injections in the area of thinning hair. Once the RCI-02 injectors and consumables are available for clinical studies, RepliCel will begin preparations for phase 2 human clinical trial of this product outside of Asia (Shiseido’s licensed territory) examining both dose and injection frequency for the treatment of hair loss. Early stage discussions with potential partners outside of Asia are currently underway.

Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido its expectation that (a) they deliver to RepliCel the full clinical data set from the recently completed study of RCH-01 in Japan and (b) confirm that their license agreement remains intact without breach. RepliCel reserves the right to take the position that Shiseido’s failure to deliver the clinical data from the recently completed clinical study in Shiseido’s Territory constitutes a material breach of contract which, failing a cure, will warrant RepliCel’s termination of the agreement and revocation of Shiseido’s license resulting in RepliCel’s freedom to license the RCH-01 technology to competitors in Asia.

This company is so fucked lol. Shareholders are bugging out. Complete bust.