And let's not forget that they are adding some things to their treatment that they didn't do before. At minimum they will be adding repeat treatments and nobody knows how that will turn out. But they may also have made some other treatment changes as well.
Group 1 of 66 patients: 1 single injection, 4 sites, 3 doses, 1 placebo,
Group 2 of 66 patients: 1 single injection on Day 1 and 91, 4 sites, 3 doses, 1 placebo.
Hair counts at 12 months since last injection.
Note the inclusion criteria is male pattern baldness. The initial Phase I/IIa trails were almost 50/50, male/female. Second, RCI-02 is to be completed in 2014; hopefully they use their updated device. Third, they extended the waiting period from 6 months to 12 month from injection.The Phase I/IIa check may be due to the original mouse study which also checked at 6 months.
I have not seen anything regarding Sheseido trails, but I don't know Japanese either. The only statement to note is rather vague and general.
Quote:
We will establish the Shiseido Cell-Processing and Expansion Center in Kobe in May and use this facility as a base for related research and development aimed at future commercialization. It is expected to be some time before this innovation makes a profit. However, we expect it to be very profitable and create value and new markets in the future.
Do we have any Japanese members here? Could maybe someone get in touch with the Cluster-staff or Shiseido? What do hey intend to do? Can they give us some information? I wrote them an email, but I never got a response.
My god... these trial lengths are dreadful. What the f**k is the reason for all this?
10-08-2014 04:07 PM
joachim
come on hellouser. 52 weeks, 1 year only is better than anything i expected. you need that 52 weeks to definitely check for the right dosing and safety as well.
to me, replicel currently looks like a big deal. it looks like they take things very serious.
they developed their own injector device with a built-in peltier freezing mechanism to eliminate the need for anesthesia, if i see that correctly. this device will get approval in H2 2015 and can also be used for a lot of other dermal injections.
i also like that their other products for repairing other parts of the body.
generally, the theory of using DSC cells for repair instead of DP cells looks totally logical to me. i'm not wondering at all why all other researchers (aderans, and even nigam) failed when they simply tried to inject 2D cultured DP cells. unless you are able to exactly deliver the DP cells into the follicle bulb such injections seems totally useless to me as the free circulating into the scalp injected DP cells have no chance to reach the inside follicle bulb to be able to attach to the other cells and thus, repair the dermal papilla as a whole. for the free circulating cells the outer root sheath and dermal cup sheath are like a wall which they can't break through.
that's not the case with DSC cells as they can easily attach to the miniaturized dermal cup sheath from outside, thus repairing the affected follicle. and if it's true what replicel says about the regulation of DP cells controlled by the DSC, then that's the way to go.
it's probably still a question of being a responder to it or not. will each miniaturized follicle be able to accept the injected DSC cells and produce hair again? of that i'm not sure, but the theory definitely makes sense. i'm sure it will rejuvenate a lot of dead follicles.
10-08-2014 04:14 PM
joachim
and i think shisheido definitely knows more than us and they seem to be totally convinced of the concept as well. otherwise they wouldn't build a cell culturing facility at that early time point.
i guess they or on to something big.
and the fact they are located in japan is the best thing for us.
That's not necessarily true. I swear the people on this forum jump onto information without thinking at all. The 52 weeks is not the trial length, it is the length until they provide the first set of data, the first milestone towards showing investors results if you will. I don't think they would change the trial length, these things are carefully planned.
10-08-2014 08:05 PM
macbeth81
Yes, 52 weeks after injection they will check for efficacy. One group will have two injections, so actually 91 days + 52 weeks. The trial may be longer but I wouldn't be too concern. Phase I/IIa was extended, so Phase IIb is being conducted concurrently. I would be surprised if we saw data prior to H2 2016 though. They need start the trials and stop talking about it.
10-09-2014 04:27 AM
sascha
Quote:
Originally Posted by sdsurfin
That's not necessarily true. I swear the people on this forum jump onto information without thinking at all. The 52 weeks is not the trial length, it is the length until they provide the first set of data, the first milestone towards showing investors results if you will. I don't think they would change the trial length, these things are carefully planned.
You are always the one that thinks all he says is the truth. shut the **** up and let me say what I have to say. Its written in the paper, just because you read 1 time on their website "approx. 39 months" before they even started the phase 2 doesn't mean you are right either you pathetic idiot
10-09-2014 06:11 AM
hgs1989
Quote:
Originally Posted by hellouser
Will Shiseido's also last 52 weeks?
My god... these trial lengths are dreadful. What the f**k is the reason for all this?
will if they could have produced cosmetically significant results in a shorter time, they would release results earlier to attract investors. if nothing notable comes out they will hold till the end to release statistically significant data. like the drugs of alopecia areata, they released pics before even starting trials because results were worth mentioning.
