Didn’t ARI have a deal with ICX that allows them to use ICX’s procedure if they beat them to a successful phase I? Now since ICX has completed phase I in Great Britain and has been stuck in phase II, could it be possible that ARI has decided to abandon their own procedure and go with ICX’s procedure starting from phase II using ICX’s successful phase I? This would explain why the FDA would allow them to skip phase I trials and go into their own version of phase II. Therefore, we would have ARI and ICX simultaneously doing different procedures in phase II; however, the procedure would be similar enough that the FDA would consider them both based on ICX’s successful phase I. I just find it hard to believe that no one heard of ARI doing a phase I study in Great Britain. It sounds to me like they’re finally taking advantage of the agreement they both signed to allow sharing of patented information.
Whether this is true or not I think this is good news because, either way, it appears we have two different procedures being tested in phase II.
» » I hope ARI is for real, these days you can’t trust anyone anymore
»
» ARI is definitely for real. Years ago, I was in contact with their Chief
» Scientific Officer, Kurt Stenn. He is perhaps the most knowledgeable hair
» scientist in the world. It’s also important to note the researchers
» underneath him are not junior level researchers. They are first-class
» scientists who are capable of making bleeding edge breakthroughs on their
» own merits.
»
» ARI is using a unique approach and places emphasis on 3D environments.
» Jahoda showed years ago 3D environments are necessary to maintain the cells
» at the highest level of potency. Furthermore, ARI uses a 2-cell approach
» that will go a LONG way to get around the dreaded inconsistency that has
» resulted in Gho and ICX’ work. In short, you can think of the ARI technique
» as implanting hair seeds that are fully self contained and tuned to grow
» new hair as opposed to Gho/ICX that culture and inject cells in a 2D manner
» and hope they go to the right places. In short the cells need to clump in
» order to provide a consistently proper signaling environment for growing
» hair. The clumping allows the necessary communication to jumpstart the
» process.
»
» As for time frame, it could be done in 3 years if the problems have
» already been worked out and no further refinements/adjustments are
» necessary other than dosing. However, I suspect this is not the case and 5
» years is more realistic than 3. I have no inside information that leads me
» to expect that. I’m judging purely from my observations of the problems Gho
» and ICX ran into during their efforts. (note: ICX has not given up yet so
» don’t take my post as if I’m declaring their research effort a failure. It
» is ongoing as we speak.)
I doubt that ARI will be attempting to restore a full head of hair in phase II. They’ll probably do what ICX has been doing and experiment with a small area - I think it was the size of a quarter.
» i live in n.y
» think i will head for that too.
» the thing is that i started using rogaine recently and its slowing my hair
» loss. don’t know if i should take the rish and stop it.
» what do u think guys about this trial thing, will the for e.g inject u
» with little amount of grasfts say 100 or will this trial aim at big
» numbers?
»
» if the case is so , then it might be inconvenient to go through the trial
» ,
» what do u think ?
» Advise??
We anticipate that patients will have access to hair multiplication technology by the end of the decade, and will enjoy the convenience of same-day office visits, much like the most common cosmetic procedures.
I don’t know how this is true, or how this is marketing…
Yes… I called Aderans here in NYC today.
These are Phase II studies.
They need over 100 volunteers.
I put my name on a list, and they sent me a questionaire.
Hopefully I can get in on these trials and keep everyone here informed about my progress. (If I’m accepted as a participant.)
I hope to get some more hair on my head before the end of 2010.
Maybe this is just perception but it seems like they moved through phase I very quickly (atleast compared to Intercytex). I feel like it was relatively recent (about a year ago) when they started phase I.
I assume that quick is possibly a good sign that things went to plan. Hopefully phase II will be shorter than that of Intercytex. By the way, does anybody know when Intercytex is supposed to completely finish and post final phase II results?
» Yes… I called Aderans here in NYC today.
» These are Phase II studies.
» They need over 100 volunteers.
» I put my name on a list, and they sent me a questionaire.
» Hopefully I can get in on these trials and keep everyone here informed
» about my progress. (If I’m accepted as a participant.)
» I hope to get some more hair on my head before the end of 2010.
Aderans, ACELL, Follica, Histogen. I wish them all luck.
I want to see a real solution for everyone via science, even if they already have very extensive baldness and are not good HT candidates with inadequate donor hair, etc.
Science seems to be marching forward on this front. Godspeed to it.
» Yes… I called Aderans here in NYC today.
» These are Phase II studies.
» They need over 100 volunteers.
» I put my name on a list, and they sent me a questionaire.
» Hopefully I can get in on these trials and keep everyone here informed
» about my progress. (If I’m accepted as a participant.)
» I hope to get some more hair on my head before the end of 2010.
Do you need to pay a fee for the trial and do you need to go to their clinic every month for evaluation?
» It has never happened that new stuff would be approved after phase II. All
» this phase II is just something someone like “TheGame” made up in his sick
» mind and poisoned everyone else around. ICX hoped for this in the uk,
» because there it sometimes is possible. I’ve never heard of similar process
» with FDA.
It depends, for example ICX-RHY was told by MHRA that it was classified as tissue product rather than a drug product and was outside MHRA’s jurisdiction. Hence that product didn’t have to go through any hurdles, however, later a european union legislature was passed which essentially restricts TRC to coming to the market before trials. I doubt anyone on the forum knows about current FDA jurisdiction regarding tissue engineering etc, maybe that is the reason why ARI is keeping FDA heavily in the loop (like the secretary said) so that they could get an easy approval.
Also, keep in mind that different phases are done for a reason i.e. phase-I for safety, phase-II for efficacy and phase-III for full-blown usage. In HM terms, it means that in phase-I they have to just show safety, in phase-II they have to show that it creates new hair (of good quality) and in phase-III they have to do almost full-coverage of the scalp to prove it’s ability. This is also what Intercytex was planning on doing in phase-III, test entire heads of a large number of people.
If ARI is following the same path, or when Intercytex proceeds with their Phase-III, then you could actually get into those trials to get a free head of hair - hopefully!
» Now since ICX has completed phase
» I in Great Britain and has been stuck in phase II, could it be possible
» that ARI has decided to abandon their own procedure and go with ICX’s
» procedure starting from phase II using ICX’s successful phase I? This
» would explain why the FDA would allow them to skip phase I trials and go
» into their own version of phase II.
The only way I can see ARI abandoning their research in favor of ICX is if the ICX procedure was showing extreme promise. Unfortunately, the ICX protocol is proving to have consistency problems. ARI’s research, patents, etc. are specifically designed to get around these consistency issues (thus all the added expense and complexity of the ARI procedure).
Certainly the amount of time that has elapsed since Washenik’s last interview points to something having been accomplished. Their research team is just too good to not be making any progress. I think ARI has completed and is guarding the results of their UK phase I study with heavy use of NDAs.
Compared to ICX’ protocol, ARI’s adds a lot of complexity with the use of multiple cell types, growth factors, differing culturing technology, matrix materials, implantation techniques, etc. The FDA requires proof that all of these materials in ARI specific combinations can be used safely prior to allowing a more detailed dosing and efficacy study to take place. Getting to this point with a fairly consistent protocol has taken much time off ARI’s clock, but, IMHO, they have passed this milestone are ready to move forward with the next step.
Also, I believe the nature of the ICX/Bosley agreement is such that Bosley provides ICX with a set amount of money for achieving specific milestones. I do not believe clauses exist in the contract that allow the companies to share research milestones/secrets in each others’ HM protocols. If this were not the case, the agreement would at least be between ICX and ARI as opposed to ICX and Bosley. As is, Bosley has first rights to negotiate the use of the ICX protocol. Since ICX is looking for a development partner for phase III, Bosley will have to draft a new contract with ICX if it decides to continue to pursue this technology.
They didn’t say anything about a fee.
I should get more details next week.
They only had a skeleton staff on duty when I called yesterday.
They are looking for dozens of volunteers in several cities.
i called on friday
they asked me several questions , but somehow after i hang up, didn’t understand why he said sorry to me
was it that i am not eligible or was he saying it out of politness?
what did they tell u?
100 volunteers!! Thats a real trial!!
Not like the phoney trials ICX has been doing, with ridiculously small “cohorts”, and with ridiculously small budgets.
» Yes… I called Aderans here in NYC today.
» These are Phase II studies.
» They need over 100 volunteers.
» I put my name on a list, and they sent me a questionaire.
» Hopefully I can get in on these trials and keep everyone here informed
» about my progress. (If I’m accepted as a participant.)
» I hope to get some more hair on my head before the end of 2010.
» 100 volunteers!! Thats a real trial!!
» Not like the phoney trials ICX has been doing, with ridiculously small
» “cohorts”, and with ridiculously small budgets.
»
»
» » Yes… I called Aderans here in NYC today.
» » These are Phase II studies.
» » They need over 100 volunteers.
» » I put my name on a list, and they sent me a questionaire.
» » Hopefully I can get in on these trials and keep everyone here informed
» » about my progress. (If I’m accepted as a participant.)
» » I hope to get some more hair on my head before the end of 2010.
Good stuff although i would imagine one of the conditions of the trial would be that you are not allowed to post info on forums? Exciting stuff anyway!
She said that Aderans would have to go through all trials FDA will require. Didn’t specifically say phase-III, just said we have to go through all the trials required by FDA.
Each patient will follow up after injections for about 12-14 months. Add to that the time to recruit patients (1-2 months) and culture cells (2 months), we are easily looking at almost a two year timeline for phase-II. So the phase-II will last till the end of 2010 and I doubt its coming out that year as well. Also, the way she said as many times to get the efficacy right sort of hinted at a rolling trial like Intercytex where they will treat several cohorts.
» i called on friday
» they asked me several questions , but somehow after i hang up, didn’t
» understand why he said sorry to me
» was it that i am not eligible or was he saying it out of politness?
» what did they tell u?
I suspect one of the prerequisites for volunteers will be that you don’t use any other hairloss treatments during the trial or haven’t used any in the past (which may eliminate many of the posters here).
I got in the trial!!!
They will do a general exam first, and then give us all a date.
I’m in NYC… but there are also trials in several other cities… so everyone should try and get in.
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