When are the Replicel trials?

[Arieux]

One of the users (posting here:http://www.hairlosscure2020.com/spironolactone/) managed to contact Replicel and asked them about phase 2 and their presence during last dermatological congress. Here is their reply:

Thank you for your questions. We are still working towards conducting a phase 2 trial in Germany for RCH-01 and hope to have it started before the end of this year. You are correct about Shiseido, and we expect that they will be able to get their trial started ahead of the German start date. At this time, we will not be conducting a phase 2 trial in North America, only in Germany. If our phase 2 data is favorable, we will look to sell the data package to a much larger pharmaceutical company who has more experience bring products to market. They would need to conduct a multi-site phase 3 trial which would need to include North America if they wanted to sell RCH-01 in North America.

The Derm conference was a huge success. Two of our doctors, Dr. Kevin McElwee and Dr. Rolf Hoffmann both presented. I’ve attached a copy of the poster that Dr. McElwee presented, Dr. Hoffmann chaired a session.

I hope this answers your questions. I hope you have a wonderful day.

Kind Regards,

[hellouser]

One of the users (posting here:http://www.hairlosscure2020.com/spironolactone/) managed to contact Replicel and asked them about phase 2 and their presence during last dermatological congress. Here is their reply:

There you have it, USA being a complete wasteland for clinical trials. Don't even bother with America's ridiculous regulations for new age medicine with stem cells. THANKS FDA!

[JayM]

That makes sense. I guess sheishedo have the resources to sell ect in Japan to a big market. But it will be interesting to see who picks it up in North America.

[Trouse5858]

Does anyone know if Replicel would possibly be effective for enhancing facial hair? I have sparse blond hairs on my face and am not really close to being able to have a beard as too much of it is on my neck. If I could get the hair of my teenage years back plus a dope looking beard that would be a coup, to say the least.

[JayM]

I hear minox taken orally grows hair everywhere. Maybe just apply to your beard area?

[It's2014ComeOnAlready]

I think in terms of the limited approval it's more that they can only offer treatment to residents in Japan. I might be pulling that out of my a** but I think I read it somewhere.

That's nonsense. People get sex-changes, plastic surgery, and other highly invasive medical procedures in other countries around the world as foreigners. This is a punch biopsy in the back of the head, and injections into the scalp. Could be done during lunch.

Find the literature and I'll believe you.

[Desmond84]

Phase II should have started late spring of this year, but they had ,,manufacturing issues'' which are the reason for this delay. They wrote on their facebook, that the isssues are solved now and the trials will start this year.

Oh no! The trials got delayed again! This means we wont have the data for Phase 2 till 2019!

[lacazette]

Oh no! The trials got delayed again! This means we wont have the data for Phase 2 till 2019!

Where do you see that please?

And you don't talk about Sisheido own trial right?

[It's2014ComeOnAlready]

Oh no! The trials got delayed again! This means we wont have the data for Phase 2 till 2019!

Wrong. Even after the delays, they've stated they plan on releasing it in Japan in 2018.

[lacazette]

Thnaks to Arieux for posting this new pdf from replicel : http://replicel.com/wp-content/uploa...-June-2015.pdf

The sisheido trial will take 24 months, and the safety point take 52 weeks. So they could have the temporary approval before 2018. But maybe they won't want to commercialize it before the results of best doses, and big marketing plan, etc..
Anyway that sounds good

[JayM]

Man I wish we could see some pictures of that first group. Also did they do a follow up? It would be interesting to see if it prevented any more loss, which is obviously very important.

[Hemo]

Wrong. Even after the delays, they've stated they plan on releasing it in Japan in 2018.

Which means 2019...when have they kept to schedule?

[Arieux]

@JayM
In 2014 they stated clearly that prevention for futher hairloss is their main aim:

I mean you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen. That is the goal, and as I said it’s a matter of dose, and frequency that we’re trying to figure out between ourselves and Shiseido.

http://www.midasletter.com/2014/10/replicel-life-sciences-inc-ceo-david-hall-interview-podcast/

[JayM]

Yeh dude I know but like am I just meant to take their word for it? I just want to see what tests they did or something to show the new androgen resistant hair compared to the previously susceptible hair. Obviously regrowth is a good sign but that doesn't mean resistant.

I haven't missed anything regarding that have I?