» » I think whoever said that its a phase II + III trial was right. There is
» no
» » way they would keep adding more sites if it was just a phase II trial.
» If
» » they wanted to try out different formulations they could have easily
» done
» » it at their initial trial centers. I think they are going for a high
» number
» » of patients…which means probably phase III as well.
» »
» » Can anyone call them and confirm if they are still treating small
» patches
» » or larger areas now?
»
» A poster called shooter from xconomy called them. He does post on here
» every now and again so I don’t think he’ll mind if I put his post about his
» conversation with them up.
»
»
» I called the number on the Aderans site for the clinical trial
» nearest to me.
»
» I talked to a lady from the research facility who was extremely nice. She
» said they hadn’t started recruitment just yet, but that the study itself
» should start in May. Overall it lasts for about a year. She said that the
» majority of the procedure is done during the first few visits and then its
» mostly just monitoring afterwards.
»
» I was encouraged because she said the entire team at the research facility
» was excited to start it because it was a “cool study.” She went on to
» describe the procedure (of which we are already familiar) and was in awe of
» the overall concept. I was REALLY encouraged (although I tried hard to play
» dumb) because she said that once trials get to “them” (meaning the research
» company), the procedre has already been tried on people before and they are
» usually pretty sure it works. I believe her exact words were something like
» “Oh yeah, they are pretty sure.”
»
» That being said, she is just an employee and is not given any information
» with which to make that decision. She just knows that they are a late-term
» facility so by the time trials get to them they are usually safe and at
» least minimally effective.
That sounds just like the conversation I had on the phone with Lesley from the Farjo Clinic regarding ICX-TRC - She was full of it very convincing,I fell for that big time - Hope this time its different.
Exactly that is the point, I already mentioned several times:
» Overall it lasts for about a year. She said that the
» majority of the procedure is done during the first few visits and then its
» mostly just monitoring afterwards.
What in fact means: A certain HM procedure/method (in vitro or in vivo) WORKS OR WORKS NOT (hair is growing or not) as expected. So there is NO NEED for a “5 - 7 years” crap …
“these companies offer services mostly for late stage clinical trials …”
Aderans lauched phase II trails 1 year ago - right? So it’s already time for the final steps …
In addition, these (additional) research companies prepare everything what is necessary for a market release during this phase - because actually that’s their job.
» » » » I think whoever said that its a phase II + III trial was right.
» There
» » is
» » » no
» » » » way they would keep adding more sites if it was just a phase II
» » trial.
» » » If
» » » » they wanted to try out different formulations they could have
» easily
» » » done
» » » » it at their initial trial centers. I think they are going for a
» high
» » » number
» » » » of patients…which means probably phase III as well.
» » » »
» » » » Can anyone call them and confirm if they are still treating small
» » » patches
» » » » or larger areas now?
» » »
» » » It was Iron_Man who said this was a combined PhaseII+III.
» » »
» » » I think this is just a Phase II trial. Small patches in the scalp (as
» » » reported by our insider), but they are testing different variations
» » (this
» » » would explain the high numbers of trialists).
» » » I assume, when they have an optimum technique, they will proceed to
» » phase
» » » III on larger areas of the scalp.
» » »
» » » Phase II could have more trialists than Phase III because they have
» to
» » » test many different variations.
» »
» »
» » i don’t remember exactly from where i read it but somewhere were
» written
» » that fda phase 2 has about 200-300 trialists and Phase 3 has over 1000.
» i
» » don’t know are these 100% correct numbers.
»
» I recall reading something along them lines!
»
» ROLL ON HM!
» I was encouraged because she said the entire team at the research facility
» was excited to start it because it was a “cool study.” She went on to
» describe the procedure (of which we are already familiar) and was in awe of
» the overall concept. I was REALLY encouraged (although I tried hard to play
» dumb) because she said that once trials get to “them” (meaning the research
» company), the procedre has already been tried on people before and they are
» usually pretty sure it works. I believe her exact words were something like
» “Oh yeah, they are pretty sure.”
well, maybe this company is used to make late stage trials, and that is why this lady says “they are pretty sure that it works”. But I think this time is different. This is a Phase II trial, unless we have further information pointing to the contrary. And Phase I trial had “viable” results in just 30% of the trialists. The forum member who entered the trials reported that he grew just a few hairs. So I think the match score is still unknown.
» Exactly that is the point, I already mentioned several times:
»
» » Overall it lasts for about a year. She said that the
»
» » majority of the procedure is done during the first few
» visits and then its
» » mostly just monitoring afterwards.
»
» What in fact means: A certain HM procedure/method (in vitro or
» in vivo) WORKS OR WORKS NOT (hair is growing or not) as expected. So
» there is NO NEED for a “5 - 7 years” crap …
»
» And as @HaGon already mentioned correctly:
»
» “these companies offer services mostly for late stage clinical
» trials …”
»
» Aderans lauched phase II trails 1 year ago - right? So it’s already time
» for the final steps …
»
its gonna hurt so damn much if this fails:-|
» In addition, these (additional) research companies prepare everything
» what is necessary for a market release during this phase - because actually
» that’s their job.
I agree with Spanish Dude. The match score is ABSOLUTELY unknown at this point. It is unreasonable to expect that Aderans has a working solution simply because they are conducting Phase 2 trials.
People speculating about this being Phase 3 are misinformed… unfortunately. I was one of the first people to dig up information about adaptive trials, Bayesian data analysis and seamless clinical propagation. All of these concepts are theoretical approaches to research studies, but we have no way of knowing whether or not they are being implemented by Aderans.
In fact, because Aderans has made it abundantly clear that this is still Phase 2, we cannot really conclude much of anything. If things were going perfectly, Phase 3 would have started by now. It hasn’t. Clearly there are either complications with the procedure or a number of modifications/variations that have yet to be tried. We aren’t out of the woods just yet.
Having said that, we shouldn’t try to compare Aderans with ICX. The scope of this trial is vastly superior to that of Intercytex. Furthermore, the Farjo clinic had a vested interest in the success of the procedure. The attendants at Radiant Research have no reason to be optimistic or pessimistic; they just think the idea is cool.
One last thing: The fact that 30% of respondents saw “viable” results during Phase 1 isn’t as revelatory as many people assume. Often times Phase 1 is conducted under a 3+3 dose escalation format. This means that it is possible that 100% of the people who received the optimal dose saw a practical improvement in hair growth. Statistics of this nature are just too subjective to draw any wholistic conclusions.
» In fact, because Aderans has made it abundantly clear that …
Do you believe in every BS you read in any crappy press release??
Aderans has made lots of things “abundantly clear” in the past …
… and if I would be Anderans, I would play the same game. Because without this game, people wouldn’t have a lot to play, like this endless “speculating game” (topic).
» I agree with Spanish Dude. The match score is ABSOLUTELY unknown at this
» point. It is unreasonable to expect that Aderans has a working solution
» simply because they are conducting Phase 2 trials.
»
» People speculating about this being Phase 3 are misinformed…
» unfortunately. I was one of the first people to dig up information about
» adaptive trials, Bayesian data analysis and seamless clinical propagation.
» All of these concepts are theoretical approaches to research studies, but
» we have no way of knowing whether or not they are being implemented by
» Aderans.
»
» In fact, because Aderans has made it abundantly clear that this is still
» Phase 2, we cannot really conclude much of anything. If things were going
» perfectly, Phase 3 would have started by now. It hasn’t. Clearly there are
» either complications with the procedure or a number of
» modifications/variations that have yet to be tried. We aren’t out of the
» woods just yet.
»
» Having said that, we shouldn’t try to compare Aderans with ICX. The scope
» of this trial is vastly superior to that of Intercytex. Furthermore, the
» Farjo clinic had a vested interest in the success of the procedure. The
» attendants at Radiant Research have no reason to be optimistic or
» pessimistic; they just think the idea is cool.
»
» One last thing: The fact that 30% of respondents saw “viable” results
» during Phase 1 isn’t as revelatory as many people assume. Often times Phase
» 1 is conducted under a 3+3 dose escalation format. This means that it is
» possible that 100% of the people who received the optimal dose saw a
» practical improvement in hair growth. Statistics of this nature are just
» too subjective to draw any wholistic conclusions.
I hope you didn’t mind me using your post from xconomy, you do come up with some interesting posts over there shooter. You should post more here.
» Just to clarify, do we think aderan is going to start phase 3 trials in May
» or not?
No its probably phase-II. If they were doing phase-III the trials would’ve been longer than a year…but they are doing trial for one-year as per Shooter.
» What in fact means: A certain HM procedure/method (in vitro or
» in vivo) WORKS OR WORKS NOT (hair is growing or not) as expected. So
» there is NO NEED for a “5 - 7 years” crap …
be careful please!
in vitro is a controlled environment! we can not be sure that a procedure which works in vitro, will be working in the in vivo environment.
wiki:
…Many experiments in cellular biology are conducted outside of organisms or cells; because the test conditions may not correspond to the conditions inside of the organism, this may lead to results that do not correspond to the situation that arises in a living organism. Consequently, such experimental results are often annotated with in vitro, in contradistinction with in vivo.
» » What in fact means: A certain HM procedure/method (in vitro or
» » in vivo) WORKS OR WORKS NOT (hair is growing or not) as expected.
» So
» » there is NO NEED for a “5 - 7 years” crap …
»
»
» be careful please!
»
» in vitro is a controlled environment! we can not be sure that a procedure
» which works in vitro, will be working in the in vivo environment.
»
» wiki:
» …Many experiments in cellular biology are conducted outside of organisms
» or cells; because the test conditions may not correspond to the conditions
» inside of the organism, this may lead to results that do not correspond
» to the situation that arises in a living organism. Consequently, such
» experimental results are often annotated with in vitro, in
» contradistinction with in vivo.
Aderans Research: Aderans Research Expands Clinical Studies May 04, 2010 13:30 CEST
Aderans Research Institute Inc. (ARI) said today it has expanded its clinical trials on hair regeneration by an additional seven cities in the United States. Las Vegas, NV; Los Angeles, CA; and New Hyde Park, NY, have been added through clinical site company Impact Clinical Trials. Tucson, AZ; St. Louis, MO; Birmingham, AL; and St. Petersburg, FL, have been added through clinical site company Radiant Research.
Collectively, the Radiant and Impact sites will add around 80 new subjects to the study. Combined with at least twenty new additions at a site hosted by TKL Research, the second phase of ARI’s clinical study will surpass 200 subjects in total, a remarkable number of participants for a Phase 2 trial.
“The expansion of our study reflects not only the significance of the investment made by Aderans Co. Ltd of Japan, but also our confidence that we’re getting closer to a commercial viable solution to the problems of hair loss,” said Vern Liebmann, Vice President, Operations.
Added ARI Executive Vice President Ken Washenik M.D., Ph.D., “We’ve received some encouraging results from our initial Phase 2 studies and we’re eager to expand the trial, add new protocols, and refine our knowledge of the hair multiplication and regeneration process.”
Kurt Stenn M.D., Vice President of Research and Chief Scientific Officer, commented, “It is gratifying to see our research being steadily confirmed in our clinical work.”
Phase 2 launched in November of 2008. Phase 1 of ARI’s clinical study began in September of 2006 and concluded in February of 2008.
A study designed to evaluate the safety and efficacy of injections of ex vivo expanded cultured occipital autologous dermal and epidermal cells (cells cultured from your own skin cells) in patients with scalp hair loss.
Quick Facts:
Age 18-65 years, both male and female patients
Study Duration: Up to 66 weeks (only one treatment day)
Treatment: Ji Gami and Ji Gami DO injections
Sponsor: Aderans Research Institute, Inc.
» » It seams that aderans has increase (as expected) the number of trials
» » offices.
» »
» » http://www.aderansresearch.com/ari_clinicupdates.html
» ----------------------------------------
» http://www.virginiaclinicalresearch.com/ (Current Clinical Trails)
»
» Virginia Clinical Research Inc.
»
» Scalp Hair Loss (Baldness)
»
» A study designed to evaluate the safety and efficacy of injections of ex
» vivo expanded cultured occipital autologous dermal and epidermal cells
» (cells cultured from your own skin cells) in patients with scalp hair loss.
»
»
» Quick Facts:
» Age 18-65 years, both male and female patients
» Study Duration: Up to 66 weeks (only one treatment day)
»
» Treatment: Ji Gami and Ji Gami
» DO injections
» Sponsor: Aderans Research Institute, Inc.
»
» Contact: Becky Heroux
» (757) 747- 2211
» bheroux@vcrinc.org
» ----------------------------------------
»
» “Ji Gami DO” ? :lookaround:
Is it suppossed to mean an english word or a japanese word?
» Maybe Donor :-/
»
» Could be a thing. But other ideas are welcome
»
» » » It seams that aderans has increase (as expected) the number of trials
» » » offices.
» » »
» » » http://www.aderansresearch.com/ari_clinicupdates.html
» » ----------------------------------------
» » http://www.virginiaclinicalresearch.com/ (Current Clinical Trails)
» »
» » Virginia Clinical Research Inc.
» »
» » Scalp Hair Loss (Baldness)
» »
» » A study designed to evaluate the safety and efficacy of injections of
» ex
» » vivo expanded cultured occipital autologous dermal and epidermal cells
» » (cells cultured from your own skin cells) in patients with scalp hair
» loss.
» »
» »
» » Quick Facts:
» » Age 18-65 years, both male and female patients
» » Study Duration: Up to 66 weeks (only one treatment day)
» »
» » Treatment: Ji Gami and Ji Gami
» » DO injections
» » Sponsor: Aderans Research Institute, Inc.
» »
» » Contact: Becky Heroux
» » (757) 747- 2211
» » bheroux@vcrinc.org
» » ----------------------------------------
» »
» » “Ji Gami DO” ? :lookaround:
» Is it suppossed to mean an english word or a japanese word?
»
» » Maybe Donor :-/
» »
» » Could be a thing. But other ideas are welcome
» »
» » » » It seams that aderans has increase (as expected) the number of
» trials
» » » » offices.
» » » »
» » » » http://www.aderansresearch.com/ari_clinicupdates.html
» » » ----------------------------------------
» » » http://www.virginiaclinicalresearch.com/ (Current Clinical Trails)
» » »
» » » Virginia Clinical Research Inc.
» » »
» » » Scalp Hair Loss (Baldness)
» » »
» » » A study designed to evaluate the safety and efficacy of injections of
» » ex
» » » vivo expanded cultured occipital autologous dermal and epidermal
» cells
» » » (cells cultured from your own skin cells) in patients with scalp hair
» » loss.
» » »
» » »
» » » Quick Facts:
» » » Age 18-65 years, both male and female patients
» » » Study Duration: Up to 66 weeks (only one treatment day)
» » »
» » » Treatment: Ji Gami and Ji
» Gami
» » » DO injections
» » » Sponsor: Aderans Research Institute, Inc.
» » »
» » » Contact: Becky Heroux
» » » (757) 747- 2211
» » » bheroux@vcrinc.org
» » » ----------------------------------------
» » »
» » » “Ji Gami DO” ? :lookaround:
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