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Something that Puzzles Me


#1

The original plan for Phase I study of TRC was to have from 10 to 15 participants but there were only 7.
Now, Phase II has only 6 volunteers when originally, a cohort of 20 for EACH part of Phase II was expected.
Knowing a little about statistics, I vaguely remember that the lowest possible sample population before one can gain a rough but somewhat reliable statistical significance is n=30.
Even if there’s a 100% response rate from these 6 and even the next 6 to 10 – that’s still too few to say with any certainty. So what gives? Why so few?


#2

» The original plan for Phase I study of TRC was to have from 10 to 15
» participants but there were only 7.
» Now, Phase II has only 6 volunteers when originally, a cohort of 20 for
» EACH part of Phase II was expected.
» Knowing a little about statistics, I vaguely remember that the lowest
» possible sample population before one can gain a rough but somewhat
» reliable statistical significance is n=30.
» Even if there’s a 100% response rate from these 6 and even the next 6 to
» 10 – that’s still too few to say with any certainty. So what gives? Why so
» few?

Maybe since they are treating the seperate cohorts at different times, they may take a mean average from the entire group when the last cohort is done.


#3

I know…how hard would it be to get maybe 100 volunteers/ trial and inject them…we know there is no shortage since Baldie42 and Baccy have tried to get in the trials and were not called…its funny, sometimes when I talk to people about stuff (in general…it could be about paving a road or scheduling a meeting) I hear “You dont understand…its more complicated than that”…but they can never tell me why its more complicated, just that it is…but I already know why…ONLY because people make everything complicated…


#4

» I know…how hard would it be to get maybe 100 volunteers/ trial and
» inject them…we know there is no shortage since Baldie42 and Baccy have
» tried to get in the trials and were not called…its funny, sometimes
» when I talk to people about stuff (in general…it could be about paving
» a road or scheduling a meeting) I hear “You dont understand…its more
» complicated than that”…but they can never tell me why its more
» complicated, just that it is…but I already know why…ONLY because
» people make everything complicated…

Yeah, well thems the shakes I’m afraid. Even though most people here know more than anyone else on HM (that it exists for one thing) we still have a laymans perspective. The nuts and bolts of cloning cells, delivery, etc are way more complicated than we give em credit for.


#5

do you expect them to call 40000 people do the trial

10 15 0r 100 they are all like us they all have scalp they all have follicles and in those follicle they have cells ready to be cloned there is no need to call the whole world


#6

» The original plan for Phase I study of TRC was to have from 10 to 15
» participants but there were only 7.
» Now, Phase II has only 6 volunteers when originally, a cohort of 20 for
» EACH part of Phase II was expected.
» Knowing a little about statistics, I vaguely remember that the lowest
» possible sample population before one can gain a rough but somewhat
» reliable statistical significance is n=30.
» Even if there’s a 100% response rate from these 6 and even the next 6 to
» 10 – that’s still too few to say with any certainty. So what gives? Why so
» few?

Casanova,

Does the minimal statistical sample you reference apply to the way people will respond to scientific experiments, or to the way they’d respond to something else, such as what their opinion may be concerning a specific subject? (Eg., who would you elect as President?) Obviously, there would be no need to test 30 people to determine the effect of ingesting a gram of cyanide.

I guess my point is similar to what SSSSSS is saying: if it can be scientifically established that no one will suffer deleterious effects by undergoing HM based on the sampling of 6 different people, why waste the effort and resources of testing it beyond those 6 (at least for safety purposes)? By the same token, if only 20 subjects are needed to establish an efficacy rate and procedure to an acceptable percentage of the population, why go beyond that minimal number? The additional results would be redundant and an added expense.


#7

»
» Yeah, well thems the shakes I’m afraid. Even though most people here know
» more than anyone else on HM (that it exists for one thing) we still have a
» laymans perspective. The nuts and bolts of cloning cells, delivery, etc
» are way more complicated than we give em credit for.

They are not starting from scratch here…they have been working on this since at least 2001…I am not takling about developing the technology…I am talking abour performing the trials


#8

» do you expect them to call 40000 people do the trial
»
» 10 15 0r 100 they are all like us they all have scalp they all have
» follicles and in those follicle they have cells ready to be cloned there
» is no need to call the whole world

No…I would prefer 40,000, or maybe the whole world would be better…when did I ever say 40,000 ??? You think it is unrealistc to have a decent number of people in the trail ??? Hey…better yet…lets just use one person…that would be easier…he will have a scalp…and follicles…and in those follicles will be cells ready to be cloned (oh yeah…thanks for explaining the scalp, hair follicle, cell, cloning thing to me…your explanation was very enlightening and useful)…you freakin Moron


#9

»
»
» Casanova,
»
» Does the minimal statistical sample you reference apply to the way people
» will respond to scientific experiments, or to the way they’d respond to
» something else, such as what their opinion may be concerning a specific
» subject? (Eg., who would you elect as President?) Obviously, there would
» be no need to test 30 people to determine the effect of ingesting a gram of
» cyanide.
»
» I guess my point is similar to what SSSSSS is saying: if it can be
» scientifically established that no one will suffer deleterious effects by
» undergoing HM based on the sampling of 6 different people, why waste the
» effort and resources of testing it beyond those 6 (at least for safety
» purposes)? By the same token, if only 20 subjects are needed to establish
» an efficacy rate and procedure to an acceptable percentage of the
» population, why go beyond that minimal number? The additional results
» would be redundant and an added expense.

Have you read any of the hair transplant forum ??? Look at the different results different people have gotten from body hair transplants…some good responders, others not…same with propecia and minox. …How could they possibly make a conclusive statement based on 6 trailists … the human body isnt like a machine…many people may respond differently…it would help to have a stastical average from a decent number


#10

I shouldn’t have called you a moron…I apologize for that


#11

The limited number of trialists is a concern but what I’m really wondering is why they say they intend on using X number of trialists and consistently use less.


#12

Intercytex is doing “rolling trials”, testing different protocols for ICX-TRC to determine maximum efficacy. They don’t need huge numbers of people at this stage since it’s still somewhat exploratory in terms of maximum efficacy.


#13

» »
» »
» » Casanova,
» »
» » Does the minimal statistical sample you reference apply to the way
» people
» » will respond to scientific experiments, or to the way they’d respond to
» » something else, such as what their opinion may be concerning a specific
» » subject? (Eg., who would you elect as President?) Obviously, there
» would
» » be no need to test 30 people to determine the effect of ingesting a gram
» of
» » cyanide.
» »
» » I guess my point is similar to what SSSSSS is saying: if it can be
» » scientifically established that no one will suffer deleterious effects
» by
» » undergoing HM based on the sampling of 6 different people, why waste
» the
» » effort and resources of testing it beyond those 6 (at least for safety
» » purposes)? By the same token, if only 20 subjects are needed to
» establish
» » an efficacy rate and procedure to an acceptable percentage of the
» » population, why go beyond that minimal number? The additional results
» » would be redundant and an added expense.
»
»
» Have you read any of the hair transplant forum ??? Look at the different
» results different people have gotten from body hair transplants…some
» good responders, others not…same with propecia and minox. …How could
» they possibly make a conclusive statement based on 6 trailists … the
» human body isnt like a machine…many people may respond
» differently…it would help to have a stastical average from a decent
» number

I don’t really check the HT forum out very often. The point that I was trying to make above (or, more accurately, the question I was posing) was why test more than the minimum required if the minimum required for acceptable proof can be scientifically established (as opposed to statistically established).

For example, apparently, only 7 were needed to pass Phase I (safefty). Which leads me to believe that’s enough of a sampling to legally satisfy the MHRA requirement for this phase of the testing, so considering the extra expense, effort, time, etc., why test more? I don’t know the legal minimum acceptable for Phase II or III, but again, if it can be scientifically established that the sampling is “X”, why do X + 1?


#14

» » »
» » »
» » » Casanova,
» » »
» » » Does the minimal statistical sample you reference apply to the way
» » people
» » » will respond to scientific experiments, or to the way they’d respond
» to
» » » something else, such as what their opinion may be concerning a
» specific
» » » subject? (Eg., who would you elect as President?) Obviously, there
» » would
» » » be no need to test 30 people to determine the effect of ingesting a
» gram
» » of
» » » cyanide.
» » »
» » » I guess my point is similar to what SSSSSS is saying: if it can be
» » » scientifically established that no one will suffer deleterious
» effects
» » by
» » » undergoing HM based on the sampling of 6 different people, why waste
» » the
» » » effort and resources of testing it beyond those 6 (at least for
» safety
» » » purposes)? By the same token, if only 20 subjects are needed to
» » establish
» » » an efficacy rate and procedure to an acceptable percentage of the
» » » population, why go beyond that minimal number? The additional
» results
» » » would be redundant and an added expense.
» »
» »
» » Have you read any of the hair transplant forum ??? Look at the
» different
» » results different people have gotten from body hair transplants…some
» » good responders, others not…same with propecia and minox. …How
» could
» » they possibly make a conclusive statement based on 6 trailists … the
» » human body isnt like a machine…many people may respond
» » differently…it would help to have a stastical average from a decent
» » number
»
» I don’t really check the HT forum out very often. The point that I was
» trying to make above (or, more accurately, the question I was posing) was
» why test more than the minimum required if the minimum required for
» acceptable proof can be scientifically established (as opposed to
» statistically established).
»
» For example, apparently, only 7 were needed to pass Phase I (safefty).
» Which leads me to believe that’s enough of a sampling to legally satisfy
» the MHRA requirement for this phase of the testing, so considering the
» extra expense, effort, time, etc., why test more? I don’t know the legal
» minimum acceptable for Phase II or III, but again, if it can be
» scientifically established that the sampling is “X”, why do X + 1?

But there is a difference between MHRA acceptance and statistically acceptable. I mean, I’d feel way more confident to spend 20K$ on something that has been tested on 500 people than 10 people. That’s just me…


#15

Think of individual new hairs grown as different test subjects.

The philosebaceous unit has an arrector pilli muscle that all hairs in a follicular unit share (it literally grows around, connecting with all the hairs) and a sebaceous gland for each and every hair. Stem cells come from the arrector pilli and outer root sheath cells and migrate towards the dermal papilla, the individual hairs in the follicular unit have asychrnous phases and go into catagen and telogen and exogen at differnt times.

Being able to bring just one of these forth from injections of dermal papilla/inductive cellular mixes represents a “success”. If injections all over the head bring forth a reasonable head of hair on just a couple of balding men and thus making thousands and thousands of these units…it would be pretty indicative of this process being able to work on most all men. As one goes over the various sqare centimeters of the scalp, to be able to get hair growing on all of it, is really extrodinary. ICX has a chance to allay all of these fears with some pictures of this trial which I hope they will release.

When you think about it, a rolling trial of perhaps three or four sets of five or six guys should be able to predict success in just about anyone.


#16

» » » »
» » » »
» » » » Casanova,
» » » »
» » » » Does the minimal statistical sample you reference apply to the way
» » » people
» » » » will respond to scientific experiments, or to the way they’d
» respond
» » to
» » » » something else, such as what their opinion may be concerning a
» » specific
» » » » subject? (Eg., who would you elect as President?) Obviously,
» there
» » » would
» » » » be no need to test 30 people to determine the effect of ingesting a
» » gram
» » » of
» » » » cyanide.
» » » »
» » » » I guess my point is similar to what SSSSSS is saying: if it can be
» » » » scientifically established that no one will suffer deleterious
» » effects
» » » by
» » » » undergoing HM based on the sampling of 6 different people, why
» waste
» » » the
» » » » effort and resources of testing it beyond those 6 (at least for
» » safety
» » » » purposes)? By the same token, if only 20 subjects are needed to
» » » establish
» » » » an efficacy rate and procedure to an acceptable percentage of the
» » » » population, why go beyond that minimal number? The additional
» » results
» » » » would be redundant and an added expense.
» » »
» » »
» » » Have you read any of the hair transplant forum ??? Look at the
» » different
» » » results different people have gotten from body hair
» transplants…some
» » » good responders, others not…same with propecia and minox. …How
» » could
» » » they possibly make a conclusive statement based on 6 trailists …
» the
» » » human body isnt like a machine…many people may respond
» » » differently…it would help to have a stastical average from a
» decent
» » » number
» »
» » I don’t really check the HT forum out very often. The point that I was
» » trying to make above (or, more accurately, the question I was posing)
» was
» » why test more than the minimum required if the minimum required for
» » acceptable proof can be scientifically established (as opposed to
» » statistically established).
» »
» » For example, apparently, only 7 were needed to pass Phase I (safefty).
» » Which leads me to believe that’s enough of a sampling to legally
» satisfy
» » the MHRA requirement for this phase of the testing, so considering the
» » extra expense, effort, time, etc., why test more? I don’t know the
» legal
» » minimum acceptable for Phase II or III, but again, if it can be
» » scientifically established that the sampling is “X”, why do X + 1?
»
» But there is a difference between MHRA acceptance and statistically
» acceptable. I mean, I’d feel way more confident to spend 20K$ on something
» that has been tested on 500 people than 10 people. That’s just me…

I understand your point, but even 500 (which many be a statistically acceptable number) may not be enough to pass Phase III. One would think the MHRA could figure out the minimum number acceptable to approve a product–it’s what they’re in the business of doing.

I don’t know enough about cellular properties, but if their behavior is highly consistent and predictable enough accross a given spectrum, I could see where after a certain number experiments, it would just be overkill. Once the experiment has yielded a scientific proof, how many more times does that proof need to be established?


#17

» Think of individual new hairs grown as different test subjects.
»
»
» The philosebaceous unit has an arrector pilli muscle that all hairs in a
» follicular unit share (it literally grows around, connecting with all the
» hairs) and a sebaceous gland for each and every hair. Stem cells come from
» the arrector pilli and outer root sheath cells and migrate towards the
» dermal papilla, the individual hairs in the follicular unit have
» asychrnous phases and go into catagen and telogen and exogen at differnt
» times.
»
»
» Being able to bring just one of these forth from injections of dermal
» papilla/inductive cellular mixes represents a “success”. If injections all
» over the head bring forth a reasonable head of hair on just a couple of
» balding men and thus making thousands and thousands of these
» units…it would be pretty indicative of this
» process being able to work on most all men. As one goes over the various
» sqare centimeters of the scalp, to be able to get hair growing on all of
» it, is really extrodinary. ICX has a chance to allay all of these fears
» with some pictures of this trial which I hope they will release.
»
»
» When you think about it, a rolling trial of perhaps three or four sets of
» five or six guys should be able to predict success in just about anyone.

Thanks, Benji. This is what I was saying (minus all the smart stuff).


#18

All these inconsistencies do raise allot questions but I am sure that ICX could explain their actions & remove all doubts if they wanted to. They don’t seem all to concerned with the publics speculation, they haven’t been concerned about the critics from day one.
Guys, this is an incredibly stupid question & feel free to mock me but here goes…Do you think it’s possible that ICX have regrown full heads of hair behind closed doors some time ago & are now just publicly going through these phases so they can get approval?
I know it would be unethical for them to have done something like this but……ICX has had allot of answers for complex questions yet are tight lipped about some less intricate ones. I keep thinking about thegreek’s comment of how hm will come out like a bolt of lightening.


#19

» All these inconsistencies do raise allot questions but I am sure that ICX
» could explain their actions & remove all doubts if they wanted to. They
» don’t seem all to concerned with the publics speculation, they haven’t
» been concerned about the critics from day one.
» Guys, this is an incredibly stupid question & feel free to mock me but
» here goes…Do you think it’s possible that ICX have regrown full heads of
» hair behind closed doors some time ago & are now just publicly going
» through these phases so they can get approval?
» I know it would be unethical for them to have done something like this
» but……ICX has had allot of answers for complex questions yet are tight
» lipped about some less intricate ones. I keep thinking about thegreek’s
» comment of how hm will come out like a bolt of lightening.

that’s not a stupid question. i always wondered if there was something extra they knew which made them give estimate release dates.


#20

amon,

This is what maddens me – I don’t think Intercytex has grown full heads of hair, but I think they have a product that works NOW, meaning it will give you a significant increase in hairs better than propecia and minox and the rest. So in effect I think they could grow a full head of hair RIGHT NOW.

So what’s taking so long…?

This is where capitalism comes in – Intercytex has got to make a profit and so they have to “wow” investors, Bosley, and others with really good results on efficacy.

This is what I’d love to see them do: Intercytex just takes as many guys as possible and injects them over and over, damn the profits and marketing.