Sue, thanks for the info. I am still baffled that they chose to
spend time and money on the automation process, when it may be a
moot point.
If they can count T cells from hundreds of mice, can they not do the
same for such a small sample of humans?


--- In nathanfaustmantrials@yahoogroups.com, Sue root
<susan_root@...> wrote:
>
> 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.
> 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:
> 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.com, Patsy Van Huyck
> <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/nathanfaustmantrials/message/245;_ylc=
>
X3oDMTJxMmg3MXB1BF9TAzk3MzU5NzE1BGdycElkAzE2NDEyMTQ1BGdycHNwSWQDMTcwN
>
TA2MTY2MgRtc2dJZAMyNDUEc2VjA2Rtc2cEc2xrA3Ztc2cEc3RpbWUDMTE3MDU4NDUyMQ
> -->
> > >
> > >
> > >
> > > 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?
> >
>