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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 had Type 1 Diabetes for 48 years now and to hear this news is so exciting. It brings tears to my eyes actually to think there is a possibility I may not have to self medicate anymore. If, by chance you need another Participant know I am volunteering. I would love the chance to help. Thank you!
I have had Type1 since I was 2, I am 46 now. My daughter got it at 3, she is now 26. I would love to be a participant!
I too would love to be a participant!,
Hi there, we've been waiting patiently for the results of the Phase I trial to be published for over a year now...Is there a pubmed reference # for this or a link to an abstract so I can order it? This article seems like it might just be recycled old news. Hoping it's not and the data is actually published for real.
You search for trials at clinicaltrials.gov. You can also visit the website link we've provided, to the Faustman lab for more information. This is the second of two articles - the first is here: http://www.emaxhealth.com/1020/bcg-vaccine-could-reverse-type-1-diabetes-passes-phase-i-trial. I think you could easily search PubMed for the abstract though.. This IS the result of the phase I trial that was announced when the article was written - per the date shown.
my best wishes for finding the cure as diabetese is a big hurdle for the mind, body and economics of the patient and family....
I have Type 1 Diabetes for 17 yrs and would love to take part in this study. This disease is a Killer and as I grow older I know what it has done I am 47 and what to live a long life
I contacted the study group they were proud to say that they have gotten 19 million dollars in donations, but there is no brief article on the study, basic idea, No position paper, just a discussion on their money collection. CUREDM, made a product from the research from 2002, with Pancreat, a polypeptide that cured Type 1 and Type 2 diabetes. Over 500 Humans, and it reversed diabetes, type 1 and type 2. No serious side effects. FDA refused to approve it. So, I guess, Dr Faustman's team talking about money is the way to go, the FDA is clearly focused on Money and not solution. There are two other groups working on using BCG for diabetes. Also the big research study in the early 1900s with BCG, demonstrating that BCG prevents cancer. See the research of Virginia Livingston Wheeler, MD Dr Wheeler, had a lot of enemies. the problems of being smart, outspoken woman, general surgeon in the 1960s. Read the papers in the New York Academy of Science, these are the real things. No mention of Jason Fung, MD, Intensive Dietary Management, where his group has been curing Diabetes type 2 in 14 days.
32 years ago I was diagnosed with type 1. My parents brought me 4 hours away to The Joslin clinic in Boston where I was educated and treated for 20 years by one of the best endocrinologist in the world, Dr. Stuart Brink. I thank and count my blessings everyday for my parents and Dr. Brink for my success as a diabetic. This news is almost unbelievable, and so exciting for all type 1 diabetics. With additional information, I would like the opportunity to possibly live without diabetes and be part of this study. Please consider my offer for my family and all the type 1 diabetics throughout the world. Thank you so much. God bless us all.
I have two grandsons with type 1 diabetes. i have helped my youngest since he was 4 he is 9 now.the other one is 20 he was diagnosed when he was 12.Please continue with your research this would be wonderful! Thank You!
I was diagnosed with diabetes @ age 11, am now 39 & would love to participate in this study if possible. Thanks
My husband and I have type 1 diabetes. This year my husband had 4 toes amputated. I also have nerve damage in my legs from this awful disease. I would love to try this to help both of us, Thank you
I have been diabetic for 21 years and am now 28. I am in the process of getting put on the list for a double transplant in Orlando Florida as we speak. I would love to be included on any progress to wipe out this TERRIBLE disease :)
I am a new Diabetic on two insulin shots a day. Therefore I am excited to read this. Diabeties is bad on both sides of my family. I would like to participate in a study like this. Thank you all for caring enough to Cure
..OMG,I don't belive what I'm reading.I have Type 1 & Neurapathy in my legs that kill me 24/7......God bless all of you who are working so hard !
my son was 14 months old when he was diganosed(type 1 dosent run in the family) and its been 4 months now and i really wish it was me and not him. i am happy about this but i really hope there will be no bad side effects to this. it would be nice for him to be able to grow up with out having to watch how much activity u do or for him to be able to enjoy food with out having to take insline every time.
I am a diabetic type 1 , I'm 47 years old, and I'm diabetic for 32 years.After many years of discoveries announced and cure around the corner I'm a little skeptical but this study seems to be really important and I'm very hopeful particularly for children. Thanks for what you do Carlo
I'm speachless, i would Love to be a voulenteer. I have been a diabetic type 1 since i was 11 I am now 29 lost all vision in my right eye, and most in my left I have also had a kidney transplant 2 years ago. If this is true it is ddefinatly a God send If there is anyway I could get information, It would be awesome. I have scared my wifde numerous times having low blood sugar in my sleep and convulsing my 2 boys have also seen that, if I can et rid of this wasting problem I would Love it. One more thing Thank you to all the dedicated reaserchers.
I have been crying for awhile now after reading this.I have been type 1 diabetic since the age of 5.. I am now 41...It has been a heck of a road...I was blessed with 2 amazing kids,which was very hard with being diabetic to carry them and I did have problems during pregnancy and almost lost my sight and now I am a grandma of 4 beautiful angels...I never thought I would live to see a cure so I am praying to GOd to please let this be true and let it happen for all of us who suffer from this evil disease...Just a day without the hell of it would be great!!!
I have had type 1 diabetes for the past 22 years now, and I am turning 25 in 6 days. When i had read this article I was speechless. I have gone through meany ups and downs with my diabetes; and even had a struggle with it during my pregnancy with my daughter who is now 2. I have even been saving up money for an insulin pump to help regulate my sugar levels but I am no where near my goal just yet. If this is true I pray to god that I will be the first person in line to get the vaccine. Thank you to all who are working on this.
I have an extra insulin pump I am selling for 500.00 if your interested got a lot of supplies to go with it. You can contact me by email. I know how hard it is to get money for the pumps it helps a lot.
Interested in that pump for my husband. Type 1 for nearly 40 years. We do not have much money so this sounds wonderful.
My daughter is 10 - type 1 since age 2 - the thought that there could be a cure for her iin my lifetime would be such a relief. Reading the other posts here confirms the suffering this degenerative disease causes. Thank you to the Iococcas for financiallly supporting this research.
Here's question when will the vaccine be approved for canada
I'm praying so hard that this is for real!! My daughter was 6 yrs old when diagnosed with type 1, she is now 38. It has been so hard all these years. She was on the pump when she got pregnant with my granddaughter. Pump was a life saver, but we still nearly lost her and the baby. My granddaughter was diagnosed Easter 2011 with type 1 at the age of 11. I cry everytime I read about this. What an awesome miracle and blessing from God this would be for all the children and adults who are battling this disease. Mr. Iacocca, I will be asking God for a very special blessing for you and your family. Thank you for all you have done to help find a cure.
I am praying for a cure too. After almost 41 years of being Type 1, I just want to see it cured. It has been a very rough year for me. I pray for all those that have diabetes especially the young ones. I know how hard it is to be young and have this awful disease that causes so many other things. If they wipe out diabetes, heart disease, stroke, kidney failure, amputations, blindess and a lot of other things should go down. Please let this be the thing to wipe it out!
I am SPEECHLESS..... whih rarely ever happens...lol.... I have had Type 1 juevinile Insulin Dependet Diabetes since age 10..... Always very athletic, always ate very healthy,never limited myself from much due to my disease..... always used MODERATION in all I do..... I have had 2 babies, ages 5, and 1... I'm going on 24 years of this disease.... I dont have any vision poblems, no glasses, I have experienced many comas, and sizures in my sleep during pregancy. I have had 2 mal functioning Insulin Pums also....... Through it all..... I give GOD all the GLORY..... Thanking him for giving all the reseachers, Scientist, Drs, the WISDOM and KNOWLEDGE for these recent discoveries..... I'm PRAYING and BELIEVING for a COMPLETE RESTORATION in every single TYPE1 Diabetic out there.....
I have Type 1 since I was 12 and I'm 38 now. Many Ups and Downs with this Horrible disease. My greatest sympathy to the young, I was in Denial for the First 6-7 yrs. I was diagnosed. I've been in 2 coma's and 2 brain surgeries but I have not given up now! I have 2 healthy daughters , 13 and 5 which Inspire my everyday Life! I would most definetley be interested in participating.
A little update: I've taken 30 adult doses of BCG, ten of which intravenously, in June 2012. The first dose was in April. I do not have any major changes to my blood sugars to report, sadly, but I have no antibodies even though I am Type 1 (perhaps idiopathic). So make sure you test positive for either Islet Cell antibodies, Insulin antibodies, or GAD antibodies, before you drool over this result. I may have the rare care of Type 1 that's not auto-immune, but regardless, I have no antibodies but my pancreas still does not function. It was EXTREMELY difficult to get my hands on BCG, and I do not recommend injecting it intravenously to anyone as my forearm got hugely infected and is still not healed yet, six months later. I believe I may have permanent scarring at the injection sites. It is absolutely disgusting what I endured to try and rid myself of this disease, but perhaps it didn't work on me because my Type 1 is not auto-immune but rather genetic or chemical or stress-related (similar to Type2, but more extreme). Anyway, be sure to get yourselves tested for antibodies because BCG will not help you unless you have some present in your system. This will inform you of what type of type 1 you may have. Not all type 1s are the same.