Hi Karin,

I think you may be missing some points about this research.

First, we would probably have results from phase 2 by now if Dr. Faustman got the needed funding back in 2002 when she originally submitted grant requests to progress her protocol to humans. As from my last posting, her lab did not start getting the adequate funding until 2006.

Second, the pre-clinical work included collecting 1000’s of test tube blood samples from humans with type I diabetes to establish the first human blood “assay” (or test) for autoimmunity. The data was published last fall showing the selective killing off of the targeted autoreactive T-cells in these human blood samples while sparing healthy cells. This is the first indication that the treatment may work in the human clinical trial. There is no other human clinical trial that has this means of measuring the T-cell death or is attempting the actual selective “removal of disease”.

Third, we have not heard any results from the phase I human trial because it is not completed and it is a double blinded study where the scientists and the patients do not know who received BCG or a placebo. We do know that nobody will have their diabetes reversed or cured because only 2 doses of BCG are administered to each patient. We know that this is not nearly enough to kill off the autoreactive T-cells for disease removal. The importance of phase I is not only safety (although we know that BCG has an impeccable safety record in humans) but more importantly, the results of the reliability and sensitivity of the human blood assay automation system for measuring the T-cell death. This will be invaluable for the best chance of success with a proper planned protocol of increased BCG dosing in phase 2.

Lastly, since Dr. Faustman’s discovery of islet regeneration once the underlying autoimmune disease is successfully eliminated, other scientists have discovered supporting research. Surviving islet cells have been found in the cadaver pancreases of people who have lived with diabetes for over 40 years. Research has shown that islet regeneration may come from these existing islets. Stem cells have been found to exist in pancreases. This may be another possible source of islet regeneration. Dr. Faustman has stated that regeneration is not the problem as research is showing the possibility of having several sources for islet regeneration. The key to a true cure may very well be Dr. Faustman’s treatment to successfully remove the underlying disease with a safe available substance.

From: stacy_lavery <stacy_lavery@...>
Subject: [nathanfaustmantrials] Re: cure for type1 diabetes???
To: nathanfaustmantrials@yahoogroups.com
Date: Thursday, June 4, 2009, 4:56 PM

Hi Karin,

Actually, there were some experiments using over 1,000 of human blood samples that served as a proof of concept for this research.  The protocol works to kill bad t-cells in human blood, not just in mice.  This was more evidence that this treatment needed to be tested in humans. 

Here's the article that you can find linked from www.faustmanlab. org:

http://www.faustman lab.org/docs/ mediacoverage/ HarvardScience_ 8-21-08.pdf

Have you looked at her website lately?  It looks great and has lots of promising information.  I have to run right now, but the article is worth a read.  Sue might be able to chime in more on this subject as well.

Stacy Lavery

Moderator, Nathan/Faustman Trials Yahoo Group

 

--- In nathanfaustmantrial s@yahoogroups. com, "Karin Espelage" <kespelage@.. .> wrote:
>
> Sue,
>
> thanks for the information. I think what's mostly frustrating is that despite all the work that was done there is still no indication if it actually works in humans or not. That still seems to be up in the air years later. Or did I miss anything? If I understand it correctly then the only concrete result so far is that the solution works in mice and that the drug is safe.
>
> I very much hope Dr. Faustman will be proven right about this in the end. However: from what I heard so far I can't tell what the chances of success are. It was ok with me at the beginning to donate to something that might or might not work (I understand that that's the nature of medical research). By now though I had expected to hear some more concrete results (maybe results of a small scale test on a few daring volunteers).
>
> Nevertheless: thanks for all your work,
> Karin
>
>
> ----- Original Message -----
> From: Sue root
> To: nathanfaustmantrial s@yahoogroups. com
> Sent: Tuesday, June 02, 2009 2:46 PM
> Subject: Re: [nathanfaustmantria ls] Re: cure for type1 diabetes???
>
>
>
>
>
> Hi Karin
> I understand your feelings about the time-line for the Faustman project. However, in reality, the original time-line and goals of the project never changed. Dr. Faustman began seeking funding for the preclinical work and phase I human trial in 2002. The original estimated $11 million for a total of 3 years (18 months of preclinical work and 18 months for phase I) never changed. The rejections and skeptism by the science community and world renowned JDRF organization directly interfered with getting adequate funding to start the project. Even when the Iacocca Foundation launched its "Join Lee Now' campaign in August of 2004, it took almost 2 years to raise the money. Dr. Faustman's lab did not start to get the adequate funding until July of 2006. Eighteen months later, as predicted, the phase I human trial started in January of 2008 and is expected to be finished sometime this July. As you and everyone can see, once the financial support finally got to the lab in July 2006, 3 years later - as originally estimated - the work has been achieved.
> I hear your statements all the time and people are wrong when they blame the research as the problem for the delays. We will have the same problem when trying to start phase II of the human trial by the end of the year or early 2010 if we don't get the funding needed.
> After following this research since 2002 and raising over $1 million for it with an amazing group of women, every scientific goal has been surpassed thus far and the ONLY thing interfering with its progression is money.
> As far as the research in Germany, my opinion is to read the published data and contact the scientists directly to get the correct information.
>
> Sue
>
> --- On Tue, 6/2/09, Karin Espelage kespelage@.. . wrote:
>
>
> From: Karin Espelage kespelage@.. .
> Subject: Re: [nathanfaustmantria ls] Re: cure for type1 diabetes???
> To: nathanfaustmantrial s@yahoogroups. com
> Date: Tuesday, June 2, 2009, 1:15 PM
>
>
>
> "..and she told me that these countries do this all of the time - promise American's a cure, only to take their money."
>
> Boy, you sure make my native country sound like a shady banana republic! :-) Germany and the EU have very strict regulations for everything related to healthcare. I don't know anything about this clinic but I have a hard time believing that a German hospital just makes total bogus claims on a public website to cheat Americans out of their money...
>
> I've been subscribed to this group for a while. I used to donate to the Faustman research regularly. I got frustrated though after the frequent shifts in the promised timeline (and my German relatives whom I asked to donate too now think they've just given their money away to some shady American organization. ..). I understand that human trials are now finally underway. Is there any information about how it's going so far?
>
> Thanks,
> Karin
>
>
>
>
>
> ----- Original Message -----
> From: Ellen
> To: nathanfaustmantrial s@yahoogroups. com
> Sent: Monday, June 01, 2009 7:35 PM
> Subject: [nathanfaustmantria ls] Re: cure for type1 diabetes???
>
>
> I don't know about that particular website, but I do know that when my son was first diagnosed with Type 1 diabetes, 14 years ago, there was an article in our local paper for a fund raiser for a six year old who was going to go to Germany to be cured of Type 1 diabetes. I called the mother, and they were going to use islet cells. This was before the islet cell success in Canada. She went there, and was not cured. In fact, her blood sugar control never got better. They claimed that it was because she was too high and under too much stress during the journey to Germany. I spoke to my son's endo about it, and she told me that these countries do this all of the time - promise American's a cure, only to take their money.
>
> --- In nathanfaustmantrial s@yahoogroups. com, "jawad_majed" <jawad_majed@ ...> wrote:
> >
> > I have come across this clinic in germany ( www.xcell-center. com )They claim that they can cure diabetes 1 and 2 through adult stem cell treatment which sounds simple and cost effective. Any thoughts on this?
> >
>