RepliCel - Spencer Kobren's Follow Up Interview With CEO David Hall

[Pate]

I'm guessing the wnt proteins are being multiplied as a side effect of the dermal cup cells being multiplied, correct? This is probabably the only thing I haven't fully grasped yet about Replicel's treatment.

It's more that the DC cells are going to pump out growth factors which will include the wnt proteins and all the others we hear about. My understanding of the major difference between Histogen and Replicel is that Replicel will inject the cells and let them express the genes and growth factors in vivo, whereas Histogen will culture the cells in the lab where gene expression and production of growth factors happens in vitro, then they inject the growth factors directly.

But as far as Replicel is concerned, basically there is going to be a hyper-expression of genes and growth factors in vivo such as hasn't been seen in the scalp since you were a developing embryo. Who knows what that might do? It SHOULD be okay but there might be unknown processes going on that nobody yet knows about. Better safe than sorry.

The other big unknown is the purity of the stem cells. We know that the cells have to go through several generations to make enough cells to be useful, and we know that in previous work the stem cells at the end of the process were not the same as the original stem cells - in particular they lost their inductive ability to generate hair, which is one major reason the original 10-year estimate blew out.

So what happens if there are mutations along the line? What if a mutation happens early on and carries down through billions of daughter cells? What if those cells now hyper-express a protein that causes cancer?

I'm not saying that's likely or even possible because I don't know, I'm not an expert (I am a scientist but not a bioscientist). All I'm saying is we are talking about a process that is associated with both embryo development and cancer. And even if there's no known pathway by which cancer could result (as the Replicel guys have said), that doesn't mean one doesn't exist, because this is brand new science - we need to go through the trials and Replicel obviously agree.

Even if some of us are desperate enough to take the risk we need to remember that any serious breach of safety standards could get Replicel into big trouble and send them out of business as well as get the whole industry under extra regulation - and then nobody gets treatment.

[Follicle Death Row]

If Aderans wasn't getting good results I don't think they would have gotten that recent big 150 million investment, as investing that much money requires careful study of the data to see if everything is on the up and up, and a close-up view of the results.

For sure. Aderans are at the point of no return I think. They have sunk too much money not to get something to market (unless it was one balding Sheik to who it's chump change. ). They'll have a treatment but how effective is anyone's guess at this point. Has to be greater than 20% regrowth and no further loss ever you would think.

[Kampung101]

The reason that Aderans's autologous treatment is taking so long is because they weren't getting any results, not because it wasn't safe.

I think the thing with Aderans was that they had difficulty in the early part of their trials with trying to get good results (the issue wasn't that they were getting no results). But it seems that Aderans has now managed to get good results going further into the trial process, probably due to, as RD pounted out with Replicel finding out in research that different Dermal Papilia cells give different results, that they were able to figure out which DP cells get the best results.

If Aderans wasn't getting good results I don't think they would have gotten that recent big 150 million investment, as investing that much money requires careful study of the data to see if everything is on the up and up, and a close-up view of the results.

[Kampung101]

For those worried about the safety of this, so far there have been no reports of negative side effects in the followup after phase 1. Obviously no word of certainty can be pronounced until the official data is released in march of next year, but at least its a good sign of the probability of this being safe.

And yes, immediately giving the highest dosage possible in the 1st phase was probably a good move as to get a strong indicator of safety, instead of giving a mild dosage and then risk having safety issues come up later in trials as the dosage is increased. If everything is fine with the offical data, Replicel can then put its focus throughout the rest of the trial period on how the dosage should be administered to get to the highest possible level of efficacy.

[Kampung101]

Replicel are following good clinical practice. Even though the treatment is autologous we KNOW that some Wnt proteins are associated with cancer and we don't know for sure what will happen. Absence of evidence does not equal evidence of absence.

I'm guessing the wnt proteins are being multiplied as a side effect of the dermal cup cells being multiplied, correct? This is probabably the only thing I haven't fully grasped yet about Replicel's treatment.

[Jundam]

As a business owner and a avid reader of New Scientist and Scientific America of over 15 years - I agree completely.

This is precisely why Jundam's comments are dumb. Sorry for ranting last night Jundam. But what you suggest sadly isnt inline with the realities of this stuff...

p.s. I know 100 x more about how this stuff works then you do - so there!

Yes! Reading science magazines makes you smart! With 15 years of reading articles dumbed down to the extent that a fifth-grader can understand them you must be a genius!

I'm getting ****ing tired of pseudo-intellectuals like you.

If you cannot comprehend the possibility of human experimentation outside of regulation then you are incredibly ignorant. Unethical human experimentation has been around for a few thousand years and it isn't ever going to stop. Go on Google, and realize that what you find are only the unethical human experimentation that they didn't manage to hide well enough.

For a small group of scientists it would be incredibly easy and beneficial to work outside of regulation to prove the efficacy of their treatment before beginning clinical trials, if the desire to do so existed.

[Pate]

There was no evidence thalidomide was dangerous either, and look what happened to that. Sometimes an unknown mechanism can cause harm.

And thalidomide is partly why we go through such long trial period developing new treatments these days. Even today, these things happen: look up TGN1412 on Wiki and see what happened to the six people who were in that trial. It was 100% safe in animals at a dose 500 times stronger, yet all six humans now face cancer and a lifetime of immune disorders.

Replicel are following good clinical practice. Even though the treatment is autologous we KNOW that some Wnt proteins are associated with cancer and we don't know for sure what will happen. Absence of evidence does not equal evidence of absence.

So I don't begrudge them the time for the trials. What I would hate to see is Replicel being held up by bureaucracy and red tape at the FDA.

[CVAZBAR]

I dont see anything wrong with what Jundam said. As a matter of fact, this has been brought up before in TBT Show. Replicel has real scientist behind this and if they claim there is no evidence stating it's dangerous, I'm not sure why it's dumb to assume they could have tried it before. I rather believe a scientist than someone who reads about science. I guess it's like Spencer says, some dudes in the forum think they know it all.

[PatientlyWaiting]

Same, could keep most of my NW3 hair until then though which is promising?

Yeah, I guess. As long as the treatment gives more hair.

[headlikeafuckingorange]

I'll be like 27-29 when this stuff is available to me, depending on when it comes out. Damn.

Same, could keep most of my NW3 hair until then though which is promising?

[PatientlyWaiting]

I'll be like 27-29 when this stuff is available to me, depending on when it comes out. Damn.

[Kiwi]

The reason it would be stupid is that despite there being no evidence of safety issues when using your own cells, that doesn't mean there will never be safety issues for that type of procedure. They're not going to risk lawsuits and the end of their careers just because they were too impatient to undergo an official trial with signed waivers saying they won't be sued in case of bad side effects. As eager as they are to find a cure, they're not fanatics who will ingest or rub anything on themselves or other people the way I've read about on some forums.

Even with a signed waiver they could still be sued for bad side effects, I can't imagine they'd try it unofficially and risk destroying the entire company.

But back to the whole release date, I don't know when this stuff is going to come out, it may be 2020 for all I know, but why give people the anxiety of saying it'll be later than what the actual experts are predicting (2015)? No one here knows shit about when this will come out, but if we're going to be waiting either way, why not be positive and give yourself less anxiety by sticking with 2015?

As a business owner and a avid reader of New Scientist and Scientific America of over 15 years - I agree completely.

This is precisely why Jundam's comments are dumb. Sorry for ranting last night Jundam. But what you suggest sadly isnt inline with the realities of this stuff...

p.s. I know 100 x more about how this stuff works then you do - so there!

[Bronson]

Why would it be stupid? As David Hall has pointed out in probably every interview he has given there is absolutely no evidence or logical reason to believe a treatment of this nature can induce cancer, in fact everything in the literature points to it being completely harmless. And here's a fun fact; Scientists are suckers for evidence and logical reasoning.

Also, they're not injecting unsuspecting victims with a chemical concoction or performing experimental surgery on their kitchen table with a scissor and a stapler. If they did test this on humans while they were testing it on animals then they would've used the exact same process that they are using on the patients in the current clinical trials. So, assuming this treatment could potentially be dangerous, injecting one or two people with it before they begun clinical trials would actually put less people at risk than immediately going into clinical trials where 20 people would be exposed to the potential risk of it.

That said, there is no evidence or logical reason to believe there is any risk to it.

The reason it would be stupid is that despite there being no evidence of safety issues when using your own cells, that doesn't mean there will never be safety issues for that type of procedure. They're not going to risk lawsuits and the end of their careers just because they were too impatient to undergo an official trial with signed waivers saying they won't be sued in case of bad side effects. As eager as they are to find a cure, they're not fanatics who will ingest or rub anything on themselves or other people the way I've read about on some forums.

Even with a signed waiver they could still be sued for bad side effects, I can't imagine they'd try it unofficially and risk destroying the entire company.

But back to the whole release date, I don't know when this stuff is going to come out, it may be 2020 for all I know, but why give people the anxiety of saying it'll be later than what the actual experts are predicting (2015)? No one here knows shit about when this will come out, but if we're going to be waiting either way, why not be positive and give yourself less anxiety by sticking with 2015?

[Follicle Death Row]

Correct me if I'm wrong, but is that the anti-androgen topical treatment (that works only on DHT thats in the scalp) that is currently undergoing clinical trials?

Correct. It's actually going to come out a year earlier as an acne treatment I believe but you can be sure that there will be people getting it off label and rubbing the acne cream into their scalps. That may well have some positive effect. 17 alpha propionate I think is the chemical. Some people have been trying to make their own concoction.

[BMT]

Oh dear... Why do you bump in this thread, which is about an interview you didn't even listen to. Replicel's target IS NOT 20%. Please, listen to the interview.. I don't want to explain it again...

I didn't say thier target was 20% regrowth. I just said that if they dose up in phase one to see the potential of the science, and they only get around 20% regrowth - then we're a long way off. Sure they can go back and make changes, but its not a 'home run' as they say. I could be wrong about that, but my impressions was that in one of the interviews he said that they are going to give large doses to know if its safe, and they should know pretty much efficacy after phase one.

Im very positive about this too - but unlike histogens phase 1 trials i really hope we see something substantial - along the lines of what what many think is the potential for this. Then if they do, its a race to the finish line