Replicel Trial Update

[krewel]

Hello baldheads,

http://www.replicel.com/replicel-provides-update-on-first-in-man-clinical-trials-and-recent-corporate-activity/

Looks good so far, they're preparing for Phase II!

Best Regards

[Sogeking]

So fall 2012 is when phase II studies begin. Good to know. Can't wait. Bald Eagle 1 reporting out. Over.

[Bronson]

Sure wish they were testing more than 100 people. Does anyone have statistics on the safety record of medical products that were tested on only 100 people? Seems to me you would need to test at least 1,000 to get an accurate sense of how safe this would be. I'm sure the first 100 people who took propecia were totally fine too and it was person 100+ that felt the side effects. And yes I know this treatment is autologous (sp?) but none of us are experts and we're using amateur logic to assume this will be safe.

[TxRockClimber]

Perhaps one can take some comfort in the fact that it is a test using your own cells (autogolous) and so far there have been no reported problems with similar therapies. University of Pittsburgh and Wake Forest have used a similar approach (taking stems cells and cultivating them) to produce new bladders, esophagus, etc. without any issues. Besides multiplying the derma sheath cup - they are not doing anything your cells (besides discarding the papilla).

[Follicle Death Row]

Remember guys that phase 1 is using a dose that is an order of magnitude or two higher than what will go to market. Might have been 100 times or even more of the dose they anticipate we'll need. So imagine taking 100mg of fin a day. If phase 1 turns out to be safe then we're in the clear safety wise.

[TxRockClimber]

According to the interview just posted (http://www.baldtruthtalk.com/showthr...light=replicel) - CEO indicates that they have not seen any adverse issues or problems arise in the trial participants...I guess that a few of the participants who were injected at the beginning have already reported back to the clinic for an assessment of their health.

[BoSox]

Safety will not be an issue about Replicel, I have confidence in that.
I can't wait for the next few months, we'll get our awnser <3

[Thinning@30]

I'm glad that Replicel seems to be moving along with its trials and that its management is very optimistic about the possible results, but I am still disappointed with the estimated time to market being 2015 at the soonest. These things always seem to take longer than expected, so if 2015 is the ETA, then who knows when it will really be released. Of course, even if the 2015 estimate is accurate, this wouldn't necessarily mean the product would be relased on January 1, 2015 and be immediately available to anyone who wants it. If the company is not on top of this, there could be real lags with distribution and with training physicians in the new procedures.

I am also disappointed that in the interview, the CEO seemed to indicate that the product will undergo a full three-phase set of clinical trials, and there was no mention of an early release in non-Western countries following the completion of the Phase I safety or Phase II dosing trials. I think many of us were hoping for something like this, so that those of us willing to travel could benefit from the product sooner. There was also no mention of the controversy surrounding whether the U.S. FDA has the right to regulate autologous cell treatments, and the potential for a quicker time to market should the U.S. courts side against the FDA.

[uninformed]

Collaborative Research Agreement
RepliCel has entered into a three year collaborative research agreement with First Affiliated Hospital of Sun Yat-Sen University in China and its head of Dermatology, Dr. Xingqi Zhang, for the development of cell culture methodology for mesenchymal hair follicles. The research will involve blinded studies on optimizing cell culture.

Interesting, that university is from where i grew up. It is the best university in southern china. Maybe i'll go check it out next time i go back

[Ted]

What do you guys think will happen if you do a HT and a few years later go through a treatment with Replicel. Will you get super dense hair or will the transplanted hair fall out?

[TxRockClimber]

Thats a good question - I have read through their paper which covered the pre-clinical trial (animal study) and it did not give any guidance as to what might happen in the situation you describe (http://www.nature.com/jid/journal/v1.../5602058a.html). At least - I could not discern a definitive statement on what might be expected to happen. I guess that if you follow their theory - one would expect some increased growth to the existing hairs undergoing minaturization from the injected dermal sheath cup cells. But what about the induction/formation of totally new follicles? Betting that might be one of the top ten question/issues to be resolved during the dosing trial which is slated to start in Fall 2012.

[krewel]

What about new hair, will be resistance for DHT?

Again, yes.

[BoSox]

I wonder if I will have any hairs on my head by the time this comes out to even benifit from it :/

[krewel]

Ok but. If someone have just thinning hair, those that you stll have on your head automaticly become resistance for DHT?

Yes, the injected cells migrate to "sick" follicles and "recruit" them to DHT resistant cells, so hair gets thicker again and you stop balding.

I wonder if I will have any hairs on my head by the time this comes out to even benifit from it :/

Why shouldn't you benefit from it? If their method really works, you will be able to restore a full head of hair. They just need that little biopsy from the back of your head. That's it.

[CVAZBAR]

If RepliCel works the way the claim, you should be able to not just restore hair but also add more density right? In other words, inject more cells to where you already have hair. So I was wondering, if people would also use it in the donor area. For example, old people who have very thin donor hair. Would you be able to add more density to the WHOLE HEAD? I figured that would be key since donor hair also thins, mAybe not at the same pace but with time it can and it will. What you guys think? Density everywhere would be nice!