How will Replicel or Aderans technique be used?

[Tracy C]

If all three are "yes" then they should have a baldness cure. If any are "no" they may still have a very effective treatment for some people but not a universal cure.

A more effective treatment would be O.K. with me - if that's all this turns out to be... It's the waiting that is so hard... I mean, I've grown a lot of hair back with non-surgical treatments - and adding transplants to that made it possible for me to go out in public without wearing a wig - but I would really like more density.

[Pate]

Basically there are three things standing between Replicel and a cure, as opposed to a treatment.

1. Whether the results are permanent. Replicel hope they will be because the original cells were DHT resistant (in men at least, maybe not in women because women may not have a permanent donor zone), so the multiplied cells should in theory be as well.

2. Whether the results are compoundable. Again, there is hope because not all follicles may be in a state to regenerate at the same time, but we will have to wait and see. Nobody has yet performed multiple procedures on the same area yet - Histogen is in the process of doing so. This is IMO the deciding factor in whether it'll be a filler or not. If the results are compoundable it should be able to be used as many times as necessary to restore full density.

3. Whether new follicles can be generated or only damaged follicles rejuvenated.

If all three are "yes" then they should have a baldness cure. If any are "no" they may still have a very effective treatment for some people but not a universal cure. If they are all "no" then I guess it's back to the drawing board for them, and another ten years at least of balding for us!

[TxRockClimber]

I wonder if the FDA required that the Univ. of Pittsburgh and Wake Forest to take the process used to generate new bladders, esophagus, etc. via the same approach i.e., take stem cells from the patients body, culture (multiply), insert them into a matrix and re-insert the new organ. Need to research this to see if they had to go through the same approval process or if they were given a waiver (experimental).

[Follicle Death Row]

Only thing that could shorten the timeline (outside of advancements/delays during the safey and efficacy trials) is whether or not the FDA is successfully sued with regards to autogolous therapies. As the RepliCel CEO mentioned during the interview - a company in Colorado has taken the FDA to court to argue that the autologous therapies should not have to undergo the same trials as medicinal/pharma products as the cells have not been changed or altered. Similar in terms as to what is required for Fertility Clinics - they have not had to undergo any trials to prove that harvesting eggs (from a female) and reintroducing them (after fertilization) was not hazardous to the patients health.

I was talking to a college friend of mine the other day about autologous stem cells and the FDA and he was saying that their intervention makes sense because he said there's a real concern with contamination of autologous stem cells when multiplied, cultured and stored ex vivo/in vitro.

I was more along your line of thought but I guess we'll have to wait and see.

[Bronson]

2015 at the earliest for us all...And that's if everything goes according to plan which it never does to be honest.

Still, I think they're on the right track.

2015 in the west, it may be released elsewhere in 2014 but yeah we all have to wait out 2012-13 at least.

[TxRockClimber]

Only thing that could shorten the timeline (outside of advancements/delays during the safey and efficacy trials) is whether or not the FDA is successfully sued with regards to autogolous therapies. As the RepliCel CEO mentioned during the interview - a company in Colorado has taken the FDA to court to argue that the autologous therapies should not have to undergo the same trials as medicinal/pharma products as the cells have not been changed or altered. Similar in terms as to what is required for Fertility Clinics - they have not had to undergo any trials to prove that harvesting eggs (from a female) and reintroducing them (after fertilization) was not hazardous to the patients health.

[Follicle Death Row]

I poked around Replicel's website and it all looks wonderful - but this is still years away from being available to help women (or anyone else) with hair loss. * Sigh *

2015 at the earliest for us all...And that's if everything goes according to plan which it never does to be honest.

Still, I think they're on the right track.

[Follicle Death Row]

2 things:

1. The effects are not expected to be transient. The follicles and hair that are grown are anticipated to last forever since they should be DHT resistant.
   
2. There could be an exception to that with women who may not have a stable permanent donor zone. Hence that could be reinjection every x number of years. 3? 5? 10? Who knows.

Not sure how the hairline will be tackled but I' assuming a FUE session may be appropriate for the first 2 or 3cm (seems sensible to me). I guess it may also be possible to thicken out moth eaten donors for those few FUE patients who have pushed it too far.

[Tracy C]

Yes, it would be great and hopefully we will have better "visibility" sometime in Feb. - Mar. 2012.

I poked around Replicel's website and it all looks wonderful - but this is still years away from being available to help women (or anyone else) with hair loss. * Sigh *

[CVAZBAR]

In bald head, the stem cells remain but the progenitor cells have diminished. Replicel believes the DSC Cells carry most of the progenitor cells. If this is true, I'm assuming you wouldn't need a DHT blocker. The hairs would be DHT resistant as if the process of MPB was never triggered. That would be stupid sick!

[krewel]

It's all explained in their videos on their homepage... And for detailled information, please check Spencers Interview with Replicel.
Replicel is planned to be a real CURE. And yes. "sick" follicles will migrate to DHT resistant follicles.

[TxRockClimber]

Yes, it would be great and hopefully we will have better "visibility" sometime in Feb. - Mar. 2012. From everything that I have read (FDA website, Replicel website, etc.) - results would not be dependent on whether or not patient is male or female. The Phase I trial has a total of 19 participants of which 10 are male and 9 are female...It took them a bit longer to line up the necessary participants but I believe it was due to the fact that they wanted to find individuals who met the criteria (Norwood and Ludwig balding: III/IV vertex), good physical health and were not (nor had in the past) used any medication to treat their condition.

[Tracy C]

I was under the impression (from Replicel's website) that since they are generating the derma cup sheath from a biopsy taken in the DHT resistant area - one could assume the results would be resistant to DHT?

If that is true that would be wonderful. If that also works for women suffering with hair loss, that would be even more wonderful.

[TxRockClimber]

I was under the impression (from Replicel's website) that since they are generating the derma cup sheath from a biopsy taken in the DHT resistant area - one could assume the results would be resistant to DHT? Of course that might only cover the new telogen hairs and not the existing hairs which are just being "reinforced" by the Replicel injections. Of course - they are generating on the order of millions of derma cup sheaths from the biopsy so I guess that one could (over time) cover the entire scalp and replace all of the non-resistant DHT follicles. Only limitation is the efficacy associated with each injection and the diminishing return? Being a scientist - I would love to have a look at the animal studies and some of the preliminary results from the first participants who were injected during Ph I.

[Tracy C]

If Replicel is successful (even moderately) than I would probably "short" the stocks associated with Parent Companies of Propecia and Minoxidil as their role will be severly diminished.

I don't think so. Hereditary hair loss is progressive. Both medications will still be needed. Men will still need to block DHT and women will still be stuck with Minoxidil and stupid high doses of Spironolactone.