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[IP] BCG Human Clinical Trial Program



Does anyone have any more info/opinion on this?

*BCG Human Clinical Trials Program*


The Faustman Lab is conducting clinical trials in long-term type 1 
diabetes through the *BCG Human Clinical Trial Program*. This program is 
testing Bacillus Calmette-Guirin (BCG), an inexpensive generic drug that 
temporarily elevates levels of TNF (a signaling protein involved in the 
body's immune responses), to see if it will benefit patients living with 
type 1 diabetes by eliminating the disease-causing T cells that attack 
and destroy the insulin-secreting cells of the pancreas.

Under the direction of Dr. Faustman and David Nathan, MD, director of 
the MGH Diabetes Center, a double-blind, placebo-controlled Phase I 
human clinical trial was conducted and demonstrated that BCG vaccination 
is not only safe in individuals with advanced type 1 diabetes, but may 
also be effective in reversing long-term disease. In the study, BCG was 
administered to adults who had been living with type 1 diabetes for an 
average of 15 years. Treatment helped eliminate the defective T cells 
that mistakenly attack and destroy the insulin-producing cells of the 
pancreas, also temporarily restoring the ability of the pancreas to 
produce small amounts of insulin. The results of the Phase I study were 
published 
<http://www.faustmanlab.org/docs/academic/JournalPone0041756.pdf> in 2012.


*Major Findings from the Phase I Trial
*The major findings from the Phase I study were:

    . The BCG vaccine with multi-dosing was safe in advanced type 1
    diabetes.

    . Although the drug was given in relatively small doses, we saw
    targeted death of the "bad" T cells that attack the
    insulin-secreting islets, an early sign that BCG has the potential
    to stop the autoimmune attack and successfully reverse disease.

    . In people living with diabetes for an average of 15 years, there
    was a transient increase in/restoration of pancreatic insulin
    secretion after BCG vaccination.


Phase II Study
A Phase II study is currently underway. The goal of the Phase II trial 
will be to identify the dose and schedule of BCG vaccination that will 
put advanced type 1 diabetes into remission and prevent long-term 
diabetic complications. For long-term restoration of insulin secretion, 
we expect that more frequent or higher BCG dosing will be needed 
compared to that used in the Phase I study. To learn more about 
participating in this research, please 
email @ redacted <mailto:email @ redacted>.

For a quick summary about the clinical trial program, please download 
our Fact Sheet. 
<http://www.faustmanlab.org/docs/clinicalt/BCG%20TRIALS%20FACT%20SHEET.pdf>

Patient information forms can be found here 
<http://www.faustmanlab.org/clinicaltrial/clinicalt_patform.html>.

Please consider supporting <https://give.massgeneral.org/faustman/> this 
important research program.
.
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