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BCG vaccine trial results announced for reversing type 1 diabetes

Kathleen Blanchard's picture
BCG vaccine for type 1 diabetes

Researchers from Massachusetts General Hospital (MGH) Immunobiology Laboratory announce findings from a phase I clinical trial that shows the generic drug BCG (bacillus Calmette-Guerin) transiently reversed type 1 diabetes in humans.

According to Denise Faustman, MD, PhD, director of MGH, "We found that even low doses of BCG could transiently reverse type 1 diabetes in human patients."

Phase II BCG trial planned for diabetes type 1 vaccine

The success of the phase I trial means the BCG vaccine, currently approved by the U.S. FDA for vaccination against tuberculosis and for the treatment of bladder cancer, is now in planning for Phase II trials.

Researchers say BCG vaccine was able to reverse type 1 diabetes by boosting tumor necrosis factor (TNF), which eliminates abnormal white blood cells responsible for type1 diabetes. The effect was seen in mice and in humans.

Treatment with the vaccine allows the pancreas to produce insulin to keep blood sugar levels in check.

Faustman explains, “One of the key components of this study was our development of a way to measure the death of the autoreactive T cells that destroy the ability of the pancreas to produce insulin. Not only did we observe and measure the death of these self-targeting immune cells, but we also saw evidence of restoration of insulin production even in patients who've had type 1 diabetes for more than a decade."

For the study, six patients with type 1 diabetes, diagnosed for an average of 15 years, received either two injections of placebo or BCG, four weeks apart.

Blood levels of autoreactive T cells, regulatory T cells that control immunity, autoantibodies that measure activity in the pancreas and levels of C-peptide that reflects insulin secretion were measured in the study participants.

Researchers compared the results to six nondiabetics and also compared the findings to samples from 75 participants with diabetes and 15 who were not diagnosed with the disease.

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Importantly, there was a temporary boost in insulin secretion, shown by increased levels of C-peptide among patients treated with BCG.

Most of the participants given the drug experienced increase in numbers of regulatory T-cells and death of autoreactive T-cells.

The scientists also noted one participant developed Epstein-Barr virus, which is known to promote expression of TNF.

"These data support our hypothesis that BCG may benefit human type 1 diabetes by boosting TNF levels," says Faustman.

The data from the EBV-infected patient show that induction of TNF expression from diverse sources may have been a missing component in two recent, unsuccessful Phase III trials that tested antibodies against the immune molecule CD3 in type 1 diabetes patients. Those trials were specifically designed to avoid reactivating any latent EBV infection, but blocking EBV activation could also block TNF expression."

Lee Iacocca is personally committed to finding a cure for type 1 diabetes.

He says, “We are hopeful that this continued research will lead to an effective and inexpensive therapy for people with the disease. I made a commitment to my late wife that I would work to find a cure for type 1 diabetes – and I, along with my daughters, continue to keep that promise."

Phase I trials for BCG vaccine show success. The drug, which has been around for 90 years and is inexpensive, may offer new treatment for those with type 1 diabetes. In clinical trials, BCG temporarily reversed the disease in mice and in humans. For more information, or to lend support, visit http://www.faustmanlab.org.

The Faustman lab has raised $17.2 million for the Phase II human clinical trial for reversing type 1 diabetes. The goal is to raise $25.2 million. If your are interested in participating in the you can e-mail [email protected]


Updated: April 18, 2014



I have no doubt about the dedication of many good people in the medical field and in no way shape or form was I trying to demeen their work and efforts. It is just frustrating to see how money and politics play such a negative role in the grand scheme of things. I apologize if you or anyone else were offended by my comments. I have seen so many htings over the years that seem so positive but then they are bought/sold and shelved in the name of greed. I still try to remain positive and I do pray for all humans suffering from chronic illnesses.
I understand Don - and I hate that it is so - you're not wrong and that does happen. I just wanted to give you a positive comment. :) No offense was taken on my part for sure. It made me sad. Sometimes the internet is full of articles and comments that say anything that is good is a scam or a sham. It isn't. I just wanted to remind you to always have hope and be positive. Don - I can "see" your good heart right through this virtual world. God Bless.
Sign me up! Type 1 for 18 years, nearly died from DKA, can't wait, so excited!
Thanks KB!! Yes, there is plenty of good in the world and I always try to stay positive. It's just really tough at times. I heard a story years ago I think at John Hopkins in which they took cells from a relative and put them in a Diabetics liver and it cured him!! Never another peep about it in the 7-10 years since. Its really frustrating!! I'd be glad to hear any updates you have ([email protected])!! Thanks =)
Interesting. I will see what I can 'uncover' for you about that in particular. :) You are welcome Don!
I am 30 years old I have been a type 1 Diabetic since I was 10. I would love a cure for this!!! It makes me smile that each day we are getting closer to cure!!!!
My 9 year old daughter is type 1 I read this article and was so excited about this I was telling a girl at work about it and she just said WOW i ask her what she was wowing that's when she told me that she was type 1 when she was younger and her grandfather had TB and that they gave her these shots to prevent her from getting the TB and after that het diabetes went away but at the time nobody realized that it was the shots that made it go away
Oh my gosh Kimberly. Did her diabetes disappear completely. She had no recurrence? What you are sharing is extremely interesting.
Yes it did she has no signs of diabetes now i ask my little girls endocrinologist about it Thursday and she is doing some research on it all cus like u told her whats the worse that could happen if she gave my little girl the shots that she would still have diabetes but a least she would be protected against TB
Kimberly, please keep us posted? Wishing your little one the very very best!
I have had diabetes for 38 yrs. I am 48 yrs old.. On insulin pump. Hoping in my lifetime there will be a cure for this disease. I am an identical twin. She does not. have diabetes ( found it interesting someone said drawing something out of a relative's liver?? ). If I could help with this clinical. Please let me know.
I have type 1 and had it for two years I'm 33 yrs old and am having very hard time , would bd interested in participating in the study. [email protected]
Seriously, where do you sign up to be a participant! I volunteer for this, it looks promising!
Hi Heather: Visit the website link in the story for more information and continual updates. Spread the word. Network with others to help with funding for this if possible. Every donation counts toward moving forward.
I am a type 1 diabetic. I've been diagnosed since 2006, I was only 26. I have had many many struggles since. It's been about 1 year since I was finally given a pump. I would absolutely be interested in being a participant or being able to help.
Hello I am soon 45 and I got my dx in 18/4-1976 and I live in sweden. Have neuropati and got pain every day. Likes this and hope for a cure so quickly as possible to get out of this pain. I want to be the first one like some many others to get out of this illness. I hope for a cure in a few years. Contact me if you want a friend and a geinypig :-)
I have had diabetes since I was 13 it's been 39 years. I would love to be a part of you research. I've been taking good care of myself, but this would be a wonderful improvement!
This is by far the closest thing to winning the lottery I could imagine. I am a 24 year old police officer and have had type 1 diabetes for 15 years and have also suffered a lot of complications and hospital stay and not to mention debt! I would give everything and anything to be apart of this even in trial stages. We diabetics need this to save our lives. I would quit my job tomorrow if I was asked to be apart of this trial and the chance to be cured once and for all. Thank you for your hard work and please continue doing so!!
I was diagnosed at 22. I'm now almost 40 I've been on an insulin pump for 12 years and am very grateful for it being a single mom to 3 kids is tough and the pump makes things much easier. This news is so exciting and i hope that trials continue. If you need and new patients for the trials I'd be more then happy to join the study. Good luck and god bless what you're doing
My daughter was 6 when we were told she has Type 1 Diabetes. She is only 10 now but anything that would stop this disease from consuming her entire life would be wonderful. Would love for her to be included if there is a trial for this.
Diagnosed with type 1 11 years ago I would also volunteer for the study...reading this brought tears to my eyes!
I've had type one diabetes for almost 3 years now. I've always taken very good care of myself and got type-1 diabetes very randomly. Not in my family at all. I would love to test this out because it would change life as I currently know it.
Im 39 and have been type 1 diabetic since I was 14. I have reoccurring dreams where im a normal healthy person again. Then I wake up in the middle of the night and realise im having a low blood sugar in my sleep. Reality sets in and I reach for my diabetes supply bag to poke my finger then gobble down some glucose tabs. I am offering up my body to participate in the human trials. While I try my best at keeping my bloodsugars level...theres only so much you can control. I say a prayer every night that God protect my kidneys, feet, sight, heart, and lets me live to see a cure. I know its out there. If I could I would donate...but I cant pay for my pump supplies as it is so reusing reservoirs n not changing my old sites as frequently as im suppose to ....well ive rambled on. Thank you for your determination in finding us a cure and thank you Lee Iacocca for pushing and funding a cure.
This would be a god send to me, My whole family is gone because of this Diabetes. I'm the only one left with it, had it since the age of 12. I'm 56 now. But the insulin pump works good with me. But I would love not having to wear it everyday without a break. I feel blessed when I take a shower without the pump for afew mins. I do hope for a cure someday, and it being a good cure for all who suffer with diabetes everyday. Like me and a lot more worldwide. I pray for the little ones who have to live out there life like I did. And the children should come first. .
Wow I can't believe that there will be a possibility that diabetes is finally going to be cured! This brought me to tears when I read it. I got diagnosed when I was 2 and I am 21 now. It's just amazing to me how much technology has developed and finally, since I was told there was almost a cure since I was 5, it is mind blowing to me that it is possibly almost here! It would be so great to finally live a normal life, where the only things I need to worry about is bills, relationships, and planning out my future. That I won't have to worry about my health with this disease anymore! That is my dream. And if anyone ever needs any volunteers in situations like these, I would be more than happy to volunteer!
I would love to be apart of this study! I was diagnosed @ age 24 on Good Friday March 28, 1997. I would love to be able to say I am diabetes free!
I've been a Type 1 diabetic since I was 2. I am 56 now. I have many complications due to the disease and it's taking it's toll. I do not want to lose my legs, I"ve already gone through retinopathy and neuropathy, gastroparesis, and much more. What are the possibilities of the vaccine working on a person like me?
I hope and pray that this is true. I have had Type 1 for 30 years and would love the chance to try this drug.
I have been waiting so long for a cure! Every visit as a small child the doctor would look at me and say, "In ten years there will be a cure!" "Hang in there, it's coming!" Forty years later I'm still hopeful and waiting. I work and stay active hoping that will keep me as good as I can stay! I was diagnosed with type 1 as a "brittle" diabetic in 1972. I work in a hospital and see the damage it can do. Along with losing a cousin at age 45. Diabetes is a daily job and struggle. Without my Mom and Dad and Son and above all God I wouldn't be here today. I enjoy life when I feel good. I want to enjoy life, feel good, and bring this new found joy to others! Keep working at it my friends and God Bless!
My husband is 28 years old and he has been diabetic since the age of 4. It would be a true miracle if we finally had a cure. A chance for him to live a "normal" life ans watch our daughter grow up. For him to walk her down the isle one day...this is our prayer. He is the most kindred spirit I have ever met, yet this brutal disease cripples him daily. God willing, this is the answer. Fingers crossed and lots of faith!