Dr. Faustman and the BCG Trial

Have you heard about Dr. Faustman? I have been following her work for about a year now. She is testing whether BCG (Bacillus Calmetta-Guerin) can be used to cure type 1 diabetes.

You know, I don’t normally get too excited when I hear the word “cure.” We’ve been hearing it for decades, and here we are, still testing and bolusing, and treating lows and highs. But this study looks different.

BCG is a generic drug with an impressive safety profile. It is currently used as a tuberculosis vaccine and to treat cancer. Dr. Faustman’s lab believes that, at higher or more frequent doses, the drug can actually target and kill the rogue T cells that destroy our beta cells.

In 2003, Dr. Faustman was the first person to actually cure diabetes in naturally diabetic mice. When the mice received BCG, the defective T cells were killed, while the healthy T cells remained. Perhaps even more amazing, the mice actually began to generate new beta cells and, as a result, the insulin they needed to survive.

The study went on to test and confirm that splenic stem cells could be used to create new beta cells in case the pancreas was not able to do so.

Of course, we know that mice and humans are two, very different … well … animals, and if we got our hopes up every time a scientist cured diabetes in mice we would spend a lot of time disappointed. What makes this study different, though, is that the mice had natural diabetes (not diabetes artificially caused in the lab,) the mice had reached old age with the disease and, perhaps most importantly, the study has been repeated and verified six different times.

Despite this success, Dr. Faustman has met with skepticism and even opposition in the field. Most striking is the JDRF’s refusal to provide monetary support, even though three labs that were funded by the JDRF confirmed Dr. Faustman’s findings. This opposition limited Dr. Faustman’s ability to raise funds to move forward with human trials for quite some time, but then the Iacocca  Family Foundation stepped up and provided a hefty donation so that the Phase I human trials could begin.

The Iacocca Family Foundation was established by Lee Iacocca in honor of his wife who died of complications of type 1 diabetes.

The latest news from the Faustman Lab is that Phase I of the human trials is complete and it was a success. Phase I was a safety trial in which the team demonstrated the safety of the treatment. The trial was a double-blinded placebo, controlled trial and the team found no severe reactions to the vaccine other than the expected inflammation at the injection site. The safety reports are now filed with the FDA and the Massachusetts General Hospital data safety monitoring boards.

Dr. Faustman is now working to raise funds for Phase II, in which the team will identify the best dose and the best timing of administration of BCG. The study can begin as soon as they have the necessary funding.

The team expects the trials to take about another eight years, and three more phases. According to the Faustman Lab website, the team is still enrolling participants and is actively seeking and accepting donations to bridge the funding gap for Phase II. You can learn more or make a donation at http://www.faustmanlab.org/index.html

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4 Comments on “Dr. Faustman and the BCG Trial”

  1. pgy Says:

    This blog is not correct in saying that the original trial in which Dr Faustman cured mice used BCG. The trial in mice used Freunds adjuvant. This also stimulate TNF. Dr Faustman is trying to reproduce the same effect in people using BCG.

    While not the same hopefully it works although BCG has been trialed previously and did not work. Dr Faustman I believe is trying to use different higher doses of BCG to stimulate higher levels of TNF. TNF kills the bad T cells and allows the pancreas to regenerate insulin producing islets.

    Or so the theory goes.

    Hopefully it works.

    • nici Says:

      pgy,

      Thanks for the clarification. Do you have a good reference that we could check out to learn more? I did not see this information in the research I did.

      Thanks again!
      nici

  2. Hdiabetes Says:

    To all Dr faustman supporters , you could help speed up the funding of Dr. Faustman’s most promising research:

    A) to reverse type 1 diabetes
    B) at cheap price (generic BCG)
    c) with the safest approach (long history of safety use)

    How: You can join the lobby group newsletter totally free at http://www.hdiabetes.com
    It’s free to join. We will be stronger in group.

  3. PDJ Says:

    I’m curious to find out what constitutes “different higher doses”. Does anyone have any idea how much she is trying to use?


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