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The procedure to separate and count the targeted T cells from whole blood samples in humans takes 1 ½ days by hand. Seeing that they plan to ultimately take blood samples every other day from the patients to monitor the effect, and they will plan to have 40 patients in the trial with controls, the automation will make this possible in a timely manner by decreasing the procedure to only about 6 hrs. More importantly, standardizing dosing in mice is much less of an issue compared to humans, even if we're talking 40 people
Even though the NOD mouse is the best known animal model for type I diabetes, when dosing in mice, one doesn't have to deal with variables such as body weight. The groups of mice are born at the same time, are the same size, and develop diabetes roughly the same time. Therefore, being able to standardize the dosing of BCG in a group of humans with such variables, will be a key factor for success.
Even though the NOD mouse is the best known animal model for type I diabetes, when dosing in mice, one doesn't have to deal with variables such as body weight. The groups of mice are born at the same time, are the same size, and develop diabetes roughly the same time. Therefore, being able to standardize the dosing of BCG in a group of humans with such variables, will be a key factor for success.
What we do know is that the NOD mice have
the same 2 defects found in humans with type I diabetes and the treatment that Dr. Faustman used targets and eliminates these defects.
stilltypeone <stilltypeone@...> wrote:
stilltypeone <stilltypeone@...> wrote:
Patsy, I think you are misunderstanding what I am inferring.
The point I am making is why spend so much time and money on a
automation process that, in the end may end up as useless. Kind of
like the "cart before the horse". Why not do the initial trial by
hand, as the mouse trials were done. If sucessful, then move on to
scale this up to a larger group trial.
I would not expect death from BCG injections, as it is used in huge
quantities for bladder cancer.
The begining trial as I understand it will be 40 individuals. I
consider that "small". I realize that is a relative term.
If asking questions is "grumbling" then I am guilty.
--- In nathanfaustmantrials@yahoogroups. , Patsy Van Huyckcom
<patsy@...> wrote:
>
> The answer in short is because if a mouse dies, nobody cares.
Just
> think if the "small human trial" was a failure either due to huge
> complications or due to the lack of results. Do you think that
they
> would just get to try again with another dose? The assay is very
> important so that the trial can be successful, and we can then
move to
> the next stage.
>
> We all want the cure to have been in 2002, but dealing with the
FDA is
> tediously slow. Grumbling isn't going to get the research done
any more
> quickly.
>
> Patsy
>
> >
> > Re: NEJM Correspondence
> >
<http://groups.yahoo.com/ group/nathanfaus tmantrials/ message/245; _ylc=
X3oDMTJxMmg3MXB1BF9TAzk3MzU5NzE1BGd ycElkAzE2NDEyMTQ 1BGdycHNwSWQDMTc wN
TA2MTY2MgRtc2dJZAMyNDUEc2VjA2Rtc2cE c2xrA3Ztc2cEc3Rp bWUDMTE3MDU4NDUy MQ
-->
> >
> >
> >
> > Posted by: "stilltypeone" stilltypeone@...
> > <mailto:stilltypeone@...?Subject= %20Re%3A% 20NEJM%
20Correspondence>
> > stilltypeone <http://profiles.yahoo.com/ >stilltypeone
> >
> >
> > Sat Feb 3, 2007 6:57 pm (PST)
> >
> > Sue, can we agree that these trials will not proceed until
> > the "automated assay" is completed?
> > Did Faustman have this automated assay during the mouse trials?
> > I am guessing the answer is no.
> > So, why the need for automation for a small human trial?
>
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