Replicel Phase II in 2015!

INT

Senior Member
Reaction score
2,838
Since I will be moving to Germany in a few months I also applied for their clinical trial. Will keep you guys updated. I hope they will accept me since I am Norwood 2 at worst with still thick denisty.

This is their proposed trial design:


  • 160 male subjects
  • Treatment Group(132 subjects)
    • 66 treated with single injection of RCH-01 (3 sites) and placebo (1 site)
    • 66 treated with repeat injections of RCH-01 (3 sites) and placebo (1 site) 3 months after initial injections
  • Control Group(28 subjects)
    • 14 treated with single injection of placebo at all 4 injections sites
    • 14 treated with repeat injections of placebo at all 4 injection sites 3 months after initial injections

  • 396 RCH-01 treated sites
  • 244 placebo sites
 

opti

Established Member
Reaction score
27
Well dr hoffmann has his clinic in Freiburg so maybe its going to be there.

I m just curious about those trials , you are being watched for about 36 months , so you aren't able to take any other things like minoxidil ,ru etc..?
 

INT

Senior Member
Reaction score
2,838
Well dr hoffmann has his clinic in Freiburg so maybe its going to be there.

I m just curious about those trials , you are being watched for about 36 months , so you aren't able to take any other things like minoxidil ,ru etc..?

Jup.... So it will only be a last resort for me if I continue to have sides on finasteride.
 

INT

Senior Member
Reaction score
2,838
Yes that would suck big time...

By the way, if the phase II trials turn out to be a success does that means we would have to fly to Japan to get a treatment? The phase II trials in Europe will take 3,5 years and then there still has to be a phase III trial before it could actually hit the market in Europe... Is it safe to say this stuff will not be available in Europe before at least 2023?
 

INT

Senior Member
Reaction score
2,838
Got a message back from Replical regarding the starting date of th German clinical trials:

"We have been working out some manufacturing issues which has delayed our application to the PEI. We have to have these issues resolved and an application submitted before the end of the year."

If there are any other questions you guys want me to ask let me know!
 

Solomon

Established Member
Reaction score
52
Got a message back from Replical regarding the starting date of th German clinical trials:

"We have been working out some manufacturing issues which has delayed our application to the PEI. We have to have these issues resolved and an application submitted before the end of the year."

If there are any other questions you guys want me to ask let me know!


before the end of the year???? Whaaat? :mad:
 

INT

Senior Member
Reaction score
2,838
before the end of the year???? Whaaat? :mad:

Jup. I think the trials in Japan will start earlier so if these would turn out to be succesful we would have to fly to Japan to get the treatment (which will probably not be before the end 2018.
 

Solomon

Established Member
Reaction score
52
Why Shiseido hasn't already started their trials? Does they also have some issues? :\
 

INT

Senior Member
Reaction score
2,838
Why Shiseido hasn't already started their trials? Does they also have some issues? :\

Don't know, if I remember correctly from hellrouser's interview they will start in a few months and they don't need an additional phase III trial (correct me if I am wrong) so it makes sense that it will be on the market much earlier than here in Europe.
 

Solomon

Established Member
Reaction score
52
Don't know, if I remember correctly from hellrouser's interview they will start in a few months and they don't need an additional phase III trial (correct me if I am wrong) so it makes sense that it will be on the market much earlier than here in Europe.

They were saying couple of WEEKS...
Maybe my hopes are too high with RCH-01... They are loosing a lot of money delaying this product
 

INT

Senior Member
Reaction score
2,838
They were saying couple of WEEKS...
Maybe my hopes are too high with RCH-01... They are loosing a lot of money delaying this product

There will always be delays dude. Annoying yes, a reason to already lose hope no.
 

Greybeer

Established Member
Reaction score
12
Is the Phase 2 trial already being done in Japan? I'm just confused so does Shiseido own Replicel? Or are they just partnering together to cure male pattern baldness. For Japan, China and South Korea Shiseido is pretty damn confident about a 2018 commercial release date!! Besides wanting to be a patient, the other question is which company to invest in!
 

INT

Senior Member
Reaction score
2,838
I will contact Replicel somewhere in the next 2 days again so if there are any questions, post them here and be as specific as possible please.
 

Solomon

Established Member
Reaction score
52
I will contact Replicel somewhere in the next 2 days again so if there are any questions, post them here and be as specific as possible please.


Ask why Shiseido didn't start their own trial.
Ask if they (replicel) has solved their manufacturing issue. If not, when they will solve it.

There are no more questions. We just need to know when they are starting trials. That's it. I'm sure nothing has changed since WHC 2015
 
Top