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Can a Tuberculosis Vaccine Reverse Type 1? Phase 1 Trial Now Underway Seeks Answer

Mar 19, 2008

Scientists at Massachusetts General Hospital (MGH) in Boston have initiated a phase 1 clinical trial to reverse type 1 diabetes.  The trial is exploring whether the promising results from the laboratory of Denise Faustman, MD, PhD, can be applied in human diabetes.

Faustman’s studies have shown that mice with a form of diabetes that closely resembles type 1 diabetes in humans can be cured. In the animal studies, a commonly used vaccine that provides protection against tuberculosis, called Bacillus Calmette-Guerin (BCG), was used effectively to deplete the abnormal immune cells that attack and destroy the insulin-producing cells of the pancreas.

The first step in the human study, which is currently enrolling volunteers, is to determine whether the same strategy using BCG vaccination can be used to modify the abnormal autoimmune cells that are present in type 1 “juvenile-onset” diabetes, sometimes called “juvenile-onset” diabetes. “We are pleased to be starting human clinical trials,” says Faustman. “Human trials take time, but we are making the step from curing diabetes in mice to determining whether it will work in men and women with diabetes.”

If blood sugar levels are well controlled in type 1, the numerous long-term complications can largely be avoided. However, the so-called intensive therapy that is required to maintain near-normal sugar levels requires life-long demands on the patient, including frequent blood sugar monitoring and at least three daily injections of insulin or use of an insulin pump, along with restrictive diets. Insulin doses must be adjusted based on blood sugar levels, dietary factors and anticipated exercise. A cure for diabetes has been highly sought after and has attracted much research interest.

The clinical trial is using the BCG vaccine for several reasons. BCG has been used safely for nearly 80 years as a tuberculosis vaccine. It is now being used in the human trial because it causes a low-grade inflammatory reaction, which in the mouse model of autoimmune diabetes lead to the destruction of the abnormal autoimmune cells.

David M. Nathan, MD, director of the MGH Diabetes Center, who is leading the human study at MGH, provides context: “This is the very first step in what is likely to be a long process in achieving a cure. We first need to determine whether the abnormal autoimmune cells that underlie type 1 diabetes can be knocked out with BCG vaccination, as occurred in the mouse studies.”

The phase I trial is being supported largely through direct and fundraising support from the Iacocca Foundation, and through support from other donors and the Massachusetts General Hospital.  The Iacocca Foundation was founded by Lee Iacocca and his family in 1984 to fund innovative approaches to a potential cure for diabetes. Trial information is available to the public at www.faustmanlab.org.

(Editor's Note: Diabetes Health has had a long relationship with Dr. Faustman, as well as the Iacocca Foudation, and has written extensively on both over the years. To read more about them, go to the following links: 3010, 3170, 3456, 4035, 4126, 4400, 4415, 4766 and 4834. To see a video interview of Dr. Faustman, click here.)


Categories: Blood Sugar, Diabetes, Diabetes, Insulin, Insulin Pumps, Islet & Pancreas Transplant, Professional Issues, Reversing Complications, Type 1 Issues



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Comments

Posted by Anonymous on 20 March 2008

Wow we have been following Dr Faustmans work for years and she has finally got this going. No thanks to ADA or JDRF who would not fund her original research. BIG thanks to the Iacocca foundation for sticking it out. Thank you, thank you, thank you

Posted by Anonymous on 20 March 2008

Could it be why for example in France where kids still get the BCG vaccine the type 1 ratio is 1 for 1000 and in ths States where we stopped BCG vaccine 1 for 300?

Posted by kaymow511 on 20 March 2008

will be avidly watching this trail, hope it turns out well and not more pie in the sky

Posted by Anonymous on 26 March 2008

I do think this article should point out that "good control" does not prevent all diabetes complication cases, nor is it even possible to achieve good control in many Type 1 diabetics. We need to stop blaming the Type 1 diabetic for not having a pancreas..

I try hard to keep my BG levels under control, but it's a shame that I am expected to be prone to lability, poor quality of life, and hypoglycemic seizures to do it...

I hope Faustman's lead was correct...

Posted by Anonymous on 28 March 2008

I had the good fortune to be in Palm Springs several years ago and attended the announcement of this study. Dr. Faustman, Lee Iaccoca, and Scott King were all there. It was an exciting time. First time I had ever dared to believe there could be a cure out there. Was great to speak with Scott afterwards, he let me down easy, said ya 10 years out, but maybe this time....

Posted by Anonymous on 28 March 2008

Didn't work for me. I had the BCG jab shortly after diagnosis of type I (simply because I hadn't had the BCG yet). Unfortunately it didn't go away...

Posted by Anonymous on 28 March 2008

To anonymous of 26 March - have you heard about DAFNE? Intensive regime leading to better control with more flexibility. A major advantage of DAFNE compared to other intensive regimes is a big reduction in significant hypos. After struggling for many years DAFNE brought my sugars under control with much improved quality of life. No more having to choose between being high or going hypo in my sleep :-)

Posted by Anonymous on 14 April 2008

In Finland my son got BCG on the second day after birth, and here in Finland we have highest rates in the world considering type 1 diabetes, even we get BCG

Posted by Anonymous on 24 April 2008

This is exciting news. However this study will take several Test Phases to determine what level of BCG can or will reverse Type 1 Diabetes which will take several years.

Another problem is say Dr.Faustman found the correct dosage and is now able to reverse Type 1. We will NEVER have this information. Why?? Because pharmaceutical industries who make billions of dollars a year over Diabetes Treatments will make damn sure this "cure" will never be acheieved. Wake up people Stem cell research and islet cell incapuslation is still "on-going" and yet still NO developments for a permanent cure??

Don't you all find it odd that Type 1's are still using insulin injections since 1921??

Thus far My A1C's are in very good control
however as a Type 1 I am still very bitter and disapointed. However be assured today's Computer Laptop is thinner then a notebook and that micro chip very advanced and is the size of a pea. Need I say more?

Posted by unknown on 24 April 2008

This is exciting news. However this study will take several Test Phases to determine what level of BCG can or will reverse Type 1 Diabetes which will take several years.

Another problem is say Dr.Faustman found the correct dosage and is now able to reverse Type 1. We will NEVER have this information. Why?? Because pharmaceutical industries who make billions of dollars a year over Diabetes Treatments will make damn sure this "cure" will never be acheieved. Wake up people everything has a price.

Stem cell research and islet cell incapuslation is still "on-going" and yet still NO developments for a permanent cure?? Come on!!!

Don't you all find it odd that Type 1's are still using insulin injections since 1921??

Thus far My A1C's are in very good control
however as a Type 1 I am still very bitter and disapointed. Be assured today's Computer Laptop is thinner and smaller then a notebook and that micro chip very advanced is now the size of a pea smaller than a paper clip. Need I say more?

Posted by Anonymous on 24 April 2008

It's important to put the prospects for a BCG "cure" into the proper context of the existing research. From my investigations, CD3 monoclonal antibody treatments seem to be our best bet at present. From another blog at another time, one of the commenters wrote the following [I've edited out extraneous info and pasted it from: http://www.discourse.net/archives/2006/12/type_1_diabetes_cure.html ]
---
"On Faustmans research I am very doubtful that this will have any effect on the disease. BCG has been tried several times both here in the U.S. at the Barbara Davis Institute
[ http://care.diabetesjournals.org/cgi/reprint/22/10/1703.pdf ]
and in Israel with no effect.
Faustman is also a founding partner in Keel Pharmaceuticals. http://www.keelpharmaceuticals.com/
Keel is hard at work at curing autoimmune diseases."
---
Let's hope Keel is on a more productive track and can use the info from this trial to its advantage.

Wes

Posted by Anonymous on 24 March 2009

I home he is able to at least alter the BCG to prevent type 1, my mother has type one and it seems to skip a generation, i do not want to endanger my unborn chlidren, If my mom could also be cured i think that would be the best day of my life

Posted by Anonymous on 15 June 2009

yes im 18 years old had diabetes
for 6 years, its hard for me to
keep my BG at "normal" they are always
high or low what can i do? well i gained
lots of weight and i just hope this works
cause im tired of meeting the doc all the time
and pricking my fingers and taking shots
sighh* hope theres a cure soon


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