Tweet
Hello all, long time lurker here. I did look at Anderan's most recent presentation last year, and the macro photos they provided are nothing short of underwhelming. What solid evidence is there, if any, that anderans can at least immunize follicles?
-
-
DHT immunity is a speculation based on the fact that they are using DP cells which harbour the Androgen receptors!
We actually should have that question answered by July this year when they announce their final Phase 2 results! Some of their trials did go for 18-24 months so they should have a clear picture of whether their treatment has staying power!Comment
-
If Aderans fails we are in big trouble though! Apart from Histogen there is nothing promising in the near future! Tsuji labs will eventually bring Hair multiplication to market but we could be middle aged men by then!Comment
-
It would be ideal if both histogen AND anderans prove to be successful, but just one of them would be a game changer. Does anyone know about this "scarless FUE" the was posted on this forum a month or two ago. Looks very promising. Advanced scarless FUE procedures supplemented by either Anderans or Histogen could make us all look like our 22 year old selves.
BUT, in any event, should not the picture/outlook for Anderans and Histogen be extremely clear by fall this year??Comment
-
Aderans I mean
Damn predictive text!Comment
-
Aderans is still my only hope! But what UK_Boy is talking about regarding response rate is also true.
I think Aderans will move to Phase 3 if:
- A Genetic test to determine whether you're a responder is found! (the next question would be: "would this test require you giving up 1cm2 of your donor area or would a simple mouth swab suffice?"
- No serious adverse events reported (i.e. cyst formation, ingrown hairs, or even possibly cancer!)
- DHT resistance for a sustained period of time! Hopefully somewhere around the 10 year mark (if you would require top ups every year that would make this therapy useless as you will eventually deplete all of your donor area by giving up 1cm2 each time)
Almost all of these questions will be answered this year and we'll be more than likely able to guess whether Aderans will be moving to Phase 3 or not!
It's going to be a BIG YEAR for hairloss that's for sure. It's going to be make or break for: Aderans, Histogen & Replicel.
If Aderans can satisfy these 3 criterias then you can be sure it will be on the market sometimes after Q4 2015.
P.S. Regarding fast-tracking Aderans approval: I have been doing a lot of reading guys and there's gonna be no way FDA would let that happen! There's some potential risks with Aderans which might further delay its FDA approval process; Here's what I found so far:
"There is a hypothesis that several cancers may arise from stem cells that exist in different tissues. These cancer stem cells are called "side population" (SP) cells and have been identified in: leukemia, breast cancer and several human cancer cell lines (central nervous system, gastrointestinal tumors, retinoblastoma). There is still a "chicken and egg" problem to be resolved, in that the cancer cells may have dedifferentiated to a stem cell-like population."
So what it means is that they don't know if these side population cells form after introduction of stem cells or if they existed prior to stem cell transplantation!
This means that FDA will require extensive amount of safety data from Aderans to ensure this therapy is not carcinogenic! Don't forget that this is the first time ever this approach has been tried in medicine to form chimeric organs!
I think once Phase 3 is completed, we might be looking at 12-18 of FDA Approval process, with FDA constantly requiring further information and explanation from ARI.Comment
-
Now being the first Human Autologous stem cell treatment means that neither FDA nor ARI are 100% sure about what type of safety studies should they be conducting and for how long!
This lack of knowledge makes FDA even more stringent and cautious in my opinion which might mean they will expect ARI to conduct its Phase 3 trial for longer than 12 months to establish safety!Comment
-
Desmond84, What if Histogen success and Aderans fails? Will it be a problem to us? I think they are having almost similar roles? Just wondering!!!Comment
-
Aderans will be out q1 2015 if everything goes to plan. They already applied for phase III trials, so they must have seen some good results in their phase II tests.Comment
-
If they can cultivate the cells from the 1st 1cm/2 strip, why would they need another 1cm/2 strip? Why not just use the same original batch and inject again? Also, why not go for repeat treatments if yield is low? So lets say we get 30% regrowth from the first round of injections another 15% from a second rate 3 months later? (obviously im guessing and making up numbers).
Why couldnt further injections be done with Aderans?Comment
Comment