[IP] BCG Human Clinical Trial Program
- To: email @ redacted
- Subject: [IP] BCG Human Clinical Trial Program
- From: email @ redacted
- Date: Thu, 18 Jun 2015 09:26:03 -0600
- Reply-To: email @ redacted
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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
<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
. 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.
Patient information forms can be found here
Please consider supporting <https://give.massgeneral.org/faustman/> this
important research program.
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