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Can a Tuberculosis Vaccine Reverse Type 1? Phase 1 Trial Now Underway Seeks Answer
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.)
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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
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?
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?
will be avidly watching this trail, hope it turns out well and not more pie in the sky
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...
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....
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...
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 :-)
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
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
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?
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?
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?
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 ]
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"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."
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Let's hope Keel is on a more productive track and can use the info from this trial to its advantage.
Wes
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