Replicel news and answers

[macbeth81]

For what it is worth, Shiseido mentioned RCH-01 in their 2015 Annual Report. Nothing we haven't already heard though. Shiseido has not yet started trials.

Shiseido opened the Shiseido Cell-Processing and Expansion Center (SPEC) in May 2014. Located in the Kobe Biomedical Innovation Cluster in Kobe, Japan, the center will be our core research and development facility for commercializing hair regenerative medicine. Targeting the clinical application of regenerative medicine to treat alopecia and thinning hair, Shiseido concluded a technical collaboration agreement in July 2013 with Canadian bioventure company RepliCel Life Sciences Inc. to acquire an exclusive geographic license to use RepliCel Hair-01 (RCH-01) hair regeneration technology in Asia, including Japan. RCH-01 is an autologous cell transplantation technology, in which specific cells isolated from the hair follicles taken from the scalp of a patient are cultured and injected into the balding scalp area, potentially stimulating residing hair follicles and promoting new growth in the balding scalp area. This technology has no risk of immune rejection because it uses the patient’s own cells. We will conduct research and development in the outstanding environment for applied regenerative medicine research in the Kobe Biomedical Innovation Cluster to commercialize this highly safe technology as soon as possible.

[Renee]

If you look at the video part 2 recently released it shows dr ohyama using ips cells to grow hair structures under mice skin. Although the video is from June 2015, per published reports he conducted that experiment in 2013. So with the recent article of shisheido claiming a cure in 2018, one can conclude in the past 2 years they have advanced that study and in fact cured hair loss. If this is true expect to here something very soon because in order to release it in 2018 they need to do trials ASAP.

[JayM]

Where as IPSCS are amazing and will offer amazing treatments in the future you need to realise that they can cause an immune response - whilst even autologous. This isn't understood too well right now but it's a hurdle. One of the first clinical trials ongoing now has also had problems with oncogenic genes.

We also have to accept that if there is no immune response Japan may chose to use allogeneic cell lines and thus making the treatment a lot cheaper - because of how Un diverse they are genetically. We unfortunately don't have that luxury - as in Western people so could be a lot more expensive.

Again this isn't really anything to do with replicel but things to think about with IPSCs. Again it might not pan out like that but the more you know haha.

[iamanidiot]

our phase 2 trial (approx 39 months) will need to be followed by a much larger phase 3 trial. needless to say, we are many years away from having a produce on the market.

from facebook

[Arieux]

@iamanidot: nothing new in that info. We know that under western regulations phase 3 is necessary. The only hope is sooner commercialisation in Japan.

[lacazette]

Yep we already know that. Maybe the 21st cure bill could slightly accelerate the phase 3 and phase4 approval, but it will take so long in western

Sisheido that maybe enhance replicel technology with their hair research center where there is some of the best hair researchers is the best hope. A big phase 2 and approval could be a reality.

What I Wonder is when they talk about 2018, they talk about temporally approval or complete approval? Cause if it's total approval, that would mean few people could have the therapy before 2018 under the temporally approval system, as it is possible during phase 2.

Who would take the risk to pay for a procedure that has safety data, but not longer cancer data? and maybe not perfect effectiveness at this point?
I think i would ^^ yes hairloss makes me crazy

[TJT]

Lauster is further ahead in the cure for baldness than any other doctor in the world. His team was looking for investors for funding to run an in vitro trials. They got denied.

Like I said, baldness is disrespected.

So you think that investors don't sink their money into a money-making venture due to disrespect? Come on man, I'm sure you're smarter than that!
The way the world works is that investors invest in ventures that will (likely) make them more money. There is no doubt that the cure for baldness would produce an enormous amount of money for the provider of the technology. It stands to reason that there wasn't adequate proof of Lauster's ability to provide the cure. Disrespect has nothing to do with business decisions.

[hellouser]

So you think that investors don't sink their money into a money-making venture due to disrespect? Come on man, I'm sure you're smarter than that!
The way the world works is that investors invest in ventures that will (likely) make them more money. There is no doubt that the cure for baldness would produce an enormous amount of money for the provider of the technology. It stands to reason that there wasn't adequate proof of Lauster's ability to provide the cure. Disrespect has nothing to do with business decisions.

Then explain their ignorance.

[TJT]

Then explain their ignorance.

Have you seen his presentation material where he presents results and proposes concise steps to reach the cure, based on what he knows from previous research? I haven't seen it, so I can't say, but it just stands to reason that it's not convincing. Nobody is stupid enough to pass up a cash cow like the cure for baldness if someone actually has it. If you have seen this material, I'd love to look at it as I'm not clear on what he's achieved.

[hellouser]

Have you seen his presentation material where he presents results and proposes concise steps to reach the cure, based on what he knows from previous research? I haven't seen it, so I can't say, but it just stands to reason that it's not convincing. Nobody is stupid enough to pass up a cash cow like the cure for baldness if someone actually has it. If you have seen this material, I'd love to look at it as I'm not clear on what he's achieved.

With that logic, how did Replicel get the funding while being behind in the race?

[rdawg]

Alot of negative speculation here, we have no idea what's going on with Replicel, they have an interesting theory but to say much beyond that is just complete guess work.

They're beginning phase II at the end of the year/early next year, they're a bit behind other companies but at the very least they are definitely starting soon. yes it took a bit to start up but sometimes companies can trend sideways and need to do a bit more research before moving forward, this was never a basic concept and they've probably made a few changes since phase I.

[Renee]

What a joke Replicel is!!! The sec should investigate this company, it can very well be a pump & dump scheme.

[iamanidiot]

i mean, they will do phase 2 trial that will take 3 years, pretty long phase 2 it means that they really dont know if the product could work or not. i have a lot of respect in replicel and its doctor/research they seems very skilled (I mean a giant like shiseido choose to buy the replicel treatment instead of develop their own, so theorically they know that they could not do a better one) and if that kind of people dont know if the product would work or not it isnt a good thing.
the hair follicle is a very complex organ but we have to care about just two type of cells dermal papilla and dermal sheat cup. the first could not be cloned the second nobody have an idea if they could work or not.
futhermore, in the last survey about if the next treatment for hair loss would be cell/cloning etc. 50% of the doctor said yes (if you would do this survey here 100% of us would say yes).
we have to think hair loss will never be cured?

[brocktherock]

It sounds stupid but look at that show silicon valley, he had something that would make billions and he still had problems with funding due to different reasons. I know its a show but it seems pretty accurate. Shiseido still took a risk on something that was not for sure at the time but on top of everything they paid replicel, they opened their own facility and funded their own trials.

[JayM]

i mean, they will do phase 2 trial that will take 3 years, pretty long phase 2 it means that they really dont know if the product could work or not. i have a lot of respect in replicel and its doctor/research they seems very skilled (I mean a giant like shiseido choose to buy the replicel treatment instead of develop their own, so theorically they know that they could not do a better one) and if that kind of people dont know if the product would work or not it isnt a good thing.
the hair follicle is a very complex organ but we have to care about just two type of cells dermal papilla and dermal sheat cup. the first could not be cloned the second nobody have an idea if they could work or not.
futhermore, in the last survey about if the next treatment for hair loss would be cell/cloning etc. 50% of the doctor said yes (if you would do this survey here 100% of us would say yes).
we have to think hair loss will never be cured?

The trial has to be that long to determine whether it does actually prevent further loss in the hair you already have.