When are the Replicel trials?

[JayM]

Hey guys

Sorry if this is already answered a lot but was it this year the trials are meant to start? Are the trials in Japan meant to start later?

Cheers!

[Arieux]

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.
,,We have resolved the manufacturing issues RepliCel faced as a result of the culture media we were using being pulled from the market by its supplier. This took considerable time, resources and ingenuity to resolve and we are very pleased with the results. The good news to have come out of this is that we believe we may now have a materially superior product because while we were addressing that issue we were also working on optimizing the product in a number of other ways which are in the final validation stages. As mentioned in other disclosures, we are now preparing our phase 2 clinical trial application to be filed this year''
https://www.facebook.com/RepliCel/posts/835420503183450

[TooMuchHairWontKillYou]

Hey guys

Sorry if this is already answered a lot but was it this year the trials are meant to start? Are the trials in Japan meant to start later?

Cheers!

Shiseidos trial had to start in Q1 this year :\ and Replicels in H1

btw Shiseido plans to commercialize rch-01 in 2018 when their trial timeline is unknown. lets see...

[lacazette]

Guys do you think that when sisheido plan a commercial use in 2018, they talk about the real final approval commercial right?

Maybe the 'limited approval commercial' that they can have after phase 2 could be sooner than 2018 no? don't you think?

[TooMuchHairWontKillYou]

Guys do you think that when sisheido plan a commercial use in 2018, they talk about the real final approval commercial right?

Maybe the 'limited approval commercial' that they can have after phase 2 could be sooner than 2018 no? don't you think?

dont expect rch01 before 2018

[lacazette]

dont expect rch01 before 2018

So you think that when sisheido talks about 2018, they talk about the "limited approval commercial" ? after phase 2? and not the final approval after phase 3? Im not sure, what you think?

Cause if 2018 is the final approval, with the japan's laws, they could have a limited approval for commercialize it after solid phase2 and during all the phase 3 trials.

[TooMuchHairWontKillYou]

So you think that when sisheido talks about 2018, they talk about the "limited approval commercial" ? after phase 2? and not the final approval after phase 3? Im not sure, what you think?

Cause if 2018 is the final approval, with the japan's laws, they could have a limited approval for commercialize it after solid phase2 and during all the phase 3 trials.

As I know Shiseidos phase 2 will be finished by 2018 and with Japan's new laws they will be able to commercialize it.

[Arieux]

On their website there is an information:

alopecia. RepliCel’s proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. Dermal sheath cup cells will be isolated from a small punch biopsy taken from the back of the subject’s scalp. These cells will be replicated and then reintroduced into balding areas on the subjects scalp. After injections are performed subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.

http://replicel.com/product-pipeline...-regeneration/

So it wouldn't be available sooner than 2018.

[lacazette]

You probably right dude, but since sisheido do their own trials, maybe the '39months' timelapse could be different no?

In faster regulatory process in Japan it says that basically when it comes to stem cell based treatments they only need to prove safety, not efficacy.

Well imagine Sisheido talks about a complete and final approval for 2018, that could mean limited approval before that time! (okay I know Im dreaming guys^^ but 39 months is sooo long haha)
I will try to contact them to know what kind of approval they talk for 2018, hope they answer me

[Arieux]

@ lacazette: A user with nick Muhammad posted below the news (http://www.hairlosscure2020.com/japa...do/#comments):

Commercialisation is even possible after showing safety DURING phase 2, that’s what the new regulations in Japan are saying. They wouldn’t have to wait until the trial is finished

Is he right? It gave me a big hope, but I don't know exactly what this law regulation is saying. If this is truth they would be able to realize the plan of commercialisation it in 2018 despite their delay with starting the phase II trial.