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ICX-TRC Patient Information Sheet - General


#1


#2

very interesting Baldie. thanks for posting it.
it is indeed a genuine Phase II “recruitment document”.

The right limit is cut off in the scan, and some letters are missing.
Could you please tell me what does it say in the last 2 lines of the
section entitled:
“What are the possible disadvantages and risks of taking part?”
(approx. 70% the way down).

thanks


#3

» very interesting Baldie. thanks for posting it.
» it is indeed a genuine Phase II “recruitment document”.
»
» The right limit is cut off in the scan, and some letters are missing.
» Could you please tell me what does it say in the last 2 lines of the
» section entitled:
» “What are the possible disadvantages and risks of taking part?”
» (approx. 70% the way down).
»
» thanks


#4

thanks Baldie!

this is the part I was interested in:

In addition, it is possible that ICX-TRC may not be a success and that you may need to return to your current treatment method or an alternative following the study.
<<<

some questions arise here:

  1. Does this mean that you have to discontinue your current treatments (e.g. Propecia) before engaging the trial?
  2. Also, does this mean that if TRC is successful, you won’t need to go back to the previous treatments (e.g. Propecia)?

#5

»As with all surgical procedures (…) TRC, carry a risk of transmitting
»infections, such as HIV and other incurable viralinjections.

huuuu ?


#6

» »As with all surgical procedures (…) TRC, carry a risk of transmitting
» »infections, such as HIV and other incurable viralinjections.
»
» huuuu ?

they want to make sure you are a brave fellow before taking you in :slight_smile:

whats up with all these names, Fatal?


#7

We know that phase 2 started in september 2006. The document clearly states that the study lasts for 48 weeks which equates to 11 months so by my reckoning the study will finish in aug/sept. Intercytex must then decide when to make information about the study available to people like us.

We also know that 6 pateints have already been treated.

Things r looking up :slight_smile:


#8

» We know that phase 2 started in september 2006. The document clearly states
» that the study lasts for 48 weeks which equates to 11 months so by my
» reckoning the study will finish in aug/sept. Intercytex must then decide
» when to make information about the study available to people like us.
»
» We also know that 6 pateints have already been treated.
»
» Things r looking up :slight_smile:

It did not start on time,they also had a technical hold up,due to lab wanting to get it correct,earlier this year.
By my reckoning the first lot of volunteers will come to an end at end of year,at a guess.


#9

» thanks Baldie!
»
» this is the part I was interested in:
» >>>
» In addition, it is possible that ICX-TRC may not be a success and that you
» may need to return to your current treatment method or an alternative
» following the study.
» <<<
»
» some questions arise here:
»
» 1. Does this mean that you have to discontinue your current treatments
» (e.g. Propecia) before engaging the trial?

Yes you definitely would have to give up propecia as there could be conflicting results by taking both medications.

» 2. Also, does this mean that if TRC is successful, you won’t need to go
» back to the previous treatments (e.g. Propecia)?

I think not they only have you stop using propecia to insure that all results you obtain are purely from ICX-TRC. After the trial you will still need to get back onto propecia to keep your remaining hair just like in a transplant.


#10

How do you know 6 have already been treated? Where did you get that from? We will be lucky if they can complete phase 2 by Dec 2007. Does anyone know how long phase 3 will last?


#11

» » thanks Baldie!
» »
» » this is the part I was interested in:
» » >>>
» » In addition, it is possible that ICX-TRC may not be a success and that
» you
» » may need to return to your current treatment method or an alternative
» » following the study.
» » <<<
» »
» » some questions arise here:
» »
» » 1. Does this mean that you have to discontinue your current treatments
» » (e.g. Propecia) before engaging the trial?
»
» Yes you definitely would have to give up propecia as there could be
» conflicting results by taking both medications.
»
»
» » 2. Also, does this mean that if TRC is successful, you won’t need to go
» » back to the previous treatments (e.g. Propecia)?
»
» I think not they only have you stop using propecia to insure that all
» results you obtain are purely from ICX-TRC. After the trial you will still
» need to get back onto propecia to keep your remaining hair just like in a
» transplant.

While it may be true that getting back on propecia will help maintain your hair after ICX-TRC, it better not be required. I would much prefer to spend more money and get ICX-TRC every year (or whatever) for maintenance, than to keep taking propecia for maintenance. I don’t care what it costs. Part of my goal is to not only get my hair back, but to also stop taking propecia.


#12

» » 1. Does this mean that you have to discontinue your current treatments
» » (e.g. Propecia) before engaging the trial?
»
» Yes you definitely would have to give up propecia as there could be
» conflicting results by taking both medications.

Hummmm… not so sure. If you stop Propecia, you will lose hair due to that.
And you will gain hair due to HM. Then, the result will be a composite of two figures: one positive and one negative.
And thus, the results will underestimate the benefit of HM. They should be compensated upwards.
Simple fix:
obtain the negative contribution of Propecia in the non-treated areas surrounding the injection area. And, then, you can compensate the result in the treated area, and thus single out the pure contribution of HM.

Anyway, the correct thing to do would be to stop Propecia/Minoxidil 2 years before HM, and once you are stabilized, then have HM.
Or even better, having a person who has never used any medication.

»
»
» » 2. Also, does this mean that if TRC is successful, you won’t need to go
» » back to the previous treatments (e.g. Propecia)?
»
» I think not they only have you stop using propecia to insure that all
» results you obtain are purely from ICX-TRC. After the trial you will still
» need to get back onto propecia to keep your remaining hair just like in a
» transplant.

but they seem to say that only in the case that TRC doesn’t work, you will have to return to the previous treatment.
Read again:

In addition, it is possible that ICX-TRC may not be a success and that
» you
» » may need to return to your current treatment method or an alternative
» » following the study.
<<<


#13

» How do you know 6 have already been treated? Where did you get that from?
» We will be lucky if they can complete phase 2 by Dec 2007. Does anyone
» know how long phase 3 will last?

Hi Frodo:
In the last ICX report, they said that 9 trialists had been biopsied, and 6 had been injected. Or something like that.

edit:
this is the doc:
http://www.intercytex.com/icx/news/releases/2007/2007-03-23/2007-03-23.pdf

quote:

ICX-TRC
We started a Phase II trial of ICX-TRC, our cell therapy product for hair regeneration in male-pattern
baldness, in September. The process involves taking a biopsy from the subject, separating out the
relevant cells, and growing them in our facility using our proprietary process. All biopsies from the first
cohort of 9 patients have been taken and most of these patients have been treated. Further cohorts will
follow investigating variations in delivery technique. We expect to report preliminary data from this trial
around the middle of the year.
<<<<<


#14

Baldie:
were you told anything about having to stop your current medications before enrolling the TRC trials?


#15

» Baldie:
» were you told anything about having to stop your current medications
» before enrolling the TRC trials?

No,thats because I never got as far as going on pre-screening for it.

I just kept getting told a few more weeks,etc,etc.BIG NOTHING!


#16

» » Baldie:
» » were you told anything about having to stop your current medications
» » before enrolling the TRC trials?
»
» No,thats because I never got as far as going on pre-screening for it.
»
» I just kept getting told a few more weeks,etc,etc.BIG NOTHING!

not even pre-screening?
do you mean that they don’t know anything about you yet?
well, so far they have required few trialists, maybe that is why they don’t need you. This could change in the future. Phase II will require more people, and Phase III even more. Good luck!