RepliCel Reports Progress on Shiseido Technology

[yagazooci]

To me, the delays seem to have been necessary because, though nobody likes waiting, their first trial was with just 16 people. A few of them were disqualified inadvertently. Their serum for replication was inferior to what they have today; as they have switched from bovine to vegetable based serum. That process took a year to get right. Contrary to what some believe or like to think, Replicel was not asleep at the wheel, as it were. That was a "back to the drawing board" time for them, it seems. Fortunately, this new serum only takes some 5-6 weeks to replicate sufficient cell numbers whereas the bovine would take three months. Their first trial was about safety primarily, with a peek at efficacy. They didn't dose then necessarily to make hair grow. They injected huge amounts, exclusively, to ensure there were no adverse effects. Small wonder they didn't see a ton of efficacy. If you look at this next protocol in what amounts to a double (and concurrent )Phase 2, in Germany and Japan,they are using the more effective serum, testing different dosages, multiple dosages, exponentially more test subjects and data points etc.; all this times two. And they will learn from each other by collaborating. This, to me, is the true test of efficacy, not their phase 1. We have to wait and see. Their best work must be yet to come. The last thing anyone wants is to get it wrong… my view.

[brocktherock]

I don't know what to think about replicel. I feel like all my hopes are pinned on it (I don't have an interest in rubbing a topical on my head everyday). What do you guys think? It's really heartbreaking to get these glimpses of possible hop to keep our hair and have nothing ever come around. I wish the researchers could be more open with us. Sometimes replycel talks like it can be a cure, but their results were crap. I'm sure they know better than us what the potential is, and I'm not totally sure why it's even being tested when the phase 1 was bad.

What you were saying before about dosage had me double check myself but 20% in 6 months of the pilot is nothing to shake a stick at. Its pretty much guaranteed that there will be improvement upon that. If it is consistant growth instead of loss then that is huge. Then at the very least HT is a wise LONG term option. You have to admit we have never seen a huge company take charge of something like this, be eager to share details and say flat out this might be a CURE. If I had something that grew 20% or more consistently then I could get an HT and be happy, Im just worried about future loss.

[sdsurfin]

That's understandable, but what I don't understand is this dosage issue. If they used an incredibly high dose in phase I, then why would we expect better results from a lower dose? These are cells they are injecting, so you would think the more the merrier. They keep harping on the multiple shots also, but they are only doing one additional shot at 90 days. Not that this might not make a difference, but still, I feel like people are hoping for a miracle to happen. I mean I would still use it if it simply kept my existing hair, but I doubt anyone is going to put it on the market if that's all it does. Thoughts? I also don't know what the holdup is, still no word of trials starting in either japan or germany. makes you wonder.

[yagazooci]

I would imagine there are issues with depth of injection, distance between injections, logically anyway. I think that if this was easy, it would have been solved years ago. This company somehow stays afloat and true to their goals. I guess they are ensuring they are doing things correctly, in light of the demands of the competent authorites ( FDA types) too. There are probably advantages to running concurrent trials I'd say. I imagine it took some time for just the technology transfer to Shiseido; complicated beyond imagination likely. Early on, these guys spoke about injections which "awakened" existing dormant cells and forming new ones with the dosages as well. Their technology video explains that well. I think this will either work they way they believe it will or not work at all. Status quo for hair resultant hair counts is useless anyway. Thats what propecia etc. does. As for trial start times, they aren't waiting unnecessarily. seeing "shortly" on their Facebook site is encouraging. There's a lot to these things for sure with German and Japanese Competent Authorities to please. They have a ton of things in the queue too so they have to be crazy busy with Tendons, Skin aging, etc. on their plate. I think the hype on Tendons is because its much quicker to market. They will need money for future trials too. Bottom line it will be an interesting year for that company; shoot the moon or fold the tent… They seem pretty confident if that's any indication.

[Follisket]

What I really don't understand is the regrowth percentage everyone keeps talking about. Does 10-30% regrowth, for instance, refer to 10-30% of an individual's bald area, 10-30% of a full head of hair or 10-30% of the maximum extent of MPB in humans?. Because obviously, that makes a hell of a difference.
I'd really appreciate it if anyone could share some light on that.

[sdsurfin]

Another thing I don't understand: Have DSC cells been proven to maintain inductive potential in culture? If they have, then why are other scientists even bothering with dermal papillae? It seems like replicel's entire concept hinges on the inductivity and "aliveness" of the DSC cells. are there any studies that have assessed this?

[yagazooci]

This link is to an independent study which replicel recently stated further validates what they have been saying since Hoffmann and McElwee discovered how the DSCs differ from the DP etc…

http://www.replicel.com/newly-releas...tern-baldness/

[joachim]

Another thing I don't understand: Have DSC cells been proven to maintain inductive potential in culture? If they have, then why are other scientists even bothering with dermal papillae? It seems like replicel's entire concept hinges on the inductivity and "aliveness" of the DSC cells. are there any studies that have assessed this?

i too would like to know that. if they solved to multiply DSC cells with maintaining all required gene characteristics, then it's a real game changer and makes their whole concept much more promising. maybe this is something they improved in the last years which took them so long.
is there a way to ask them about that? via facebook/twitter/email? something like: the whole problem with DP cells for years is that they can't be cultured in vitro without losing gene characteristics/inductivity. are you facing similar problems with DSC cells or is that completely solved? are the multiplied DSC cells completely identical to the original ones, even after several passages?

[sdsurfin]

i too would like to know that. if they solved to multiply DSC cells with maintaining all required gene characteristics, then it's a real game changer and makes their whole concept much more promising. maybe this is something they improved in the last years which took them so long.
is there a way to ask them about that? via facebook/twitter/email? something like: the whole problem with DP cells for years is that they can't be cultured in vitro without losing gene characteristics/inductivity. are you facing similar problems with DSC cells or is that completely solved? are the multiplied DSC cells completely identical to the original ones, even after several passages?

You should try to ask them that via Facebook and email. They tend to answer, altho they are pretty curt and not very informative. they might be able to field this one though. let me know how it goes.

[brocktherock]

That's understandable, but what I don't understand is this dosage issue. If they used an incredibly high dose in phase I, then why would we expect better results from a lower dose? These are cells they are injecting, so you would think the more the merrier. They keep harping on the multiple shots also, but they are only doing one additional shot at 90 days. Not that this might not make a difference, but still, I feel like people are hoping for a miracle to happen. I mean I would still use it if it simply kept my existing hair, but I doubt anyone is going to put it on the market if that's all it does. Thoughts? I also don't know what the holdup is, still no word of trials starting in either japan or germany. makes you wonder.

I thought about that but just because they said very high doesn't mean they cant go any higher. How can you tell whats the most you can use unless you actually carry out a trial on humans? All side effects reported were considered unrelated to the procedure. It very well could be the more the merrier. After all Sheseido picked them up off results of this trial. It looks like Histogen had 70% improvement and they can't get a partner. I think they know something we don't.