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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



My son is 20 years and has had diabetes for 10 years and we would give anything to be part of this trial.
How Much You Wanna Bet That either Some Company Like Medtronic Or The government Will Not Allow The Cure To Reach The General Public ... Odds Are This Lab Will Get Paid Off Or Shut Down To Prevent Such A Hug Money Making Disease To Be cured
I have had T1 for 30 years now, and am 49. I've had paramedics to my house 3 times to bring me back from dangerously low blood sugar. I had a mini stroke 2 years ago caused by a blood clot that broke off of a blockage in my coronary artery, and had 7 stents put in for coronary artery disease. I have no feeling in my feet or lower legs, and now it is starting in my fingers. The worst thing though was going into DKA last December and almost dying, and developing AFib because of it. I've had enough, and am so ready to be cured, and would love to be part of this trial!!
I am very interested in this trial I have been fighting diabetes fir 5 years now and would love to try this
I have been a diabetic for 30 years. I am on the insulin pump now. It would be wonderful to have a cure.
I have a 15 yr son with type 1 diabetes, he was diagnosed at age 5, he also has hashimotos disease and just diagnosed with stage 1 kidney disease. Its so exciting to see them making progress with a cure.
im living in england is there anyway i can do this ?
I was diagnosed as type 1 in 1944 at age 11 and have enjoyed 70 years of guesswork in treating this condition, never ignoring the fact that I was responsible for my own care despite lack of understanding, knowledge, and treatment methods of healthcare professionals in the early days. I've done my best (almost) but have had to deal with some inevitable consequences such as neuropathy of lower limbs and now upper body including hands, coronary artery disease with resulting by-pass surgery, sight problems, emotional stress. I think the greatest development was the self blood glucose test strips and glucometer in the 1980's. I call other developments "refinements" such as pumps, rDNA insulin, CGMs. Of course, I use all of these and they help. Even to maintain a HbA1c of 6.9 to 7.3% requires lots of guessing and choosing alternatives such as strenuous bicycling vs blood sugar control. I am a Joslin Research Medalist (type 1 over 50 years) participant and attended their facility at Harvard Medical Center as a research subject as well as attending presentations by their researchers. I have been on the organizing committee of the ADA's Dallas/Fort Worth Tour de Cure annual bicycling fund raising event since the initial 2007 Tour and I am captain of a cycling team which has raised over $100,000 since 2007. I feel that this is an important way to raise funds. I hope I'm right. I get periodic reports from Joslin on their progress and have access to the ADA's Research Foundation database of grant recipients and their progress reports as well as having personal contact with staff of these organizations. I am impressed with the work of Dr. Faustman and, while competition has its values, I hope that there is some exchange of information and cooperation between all researchers in this field. I also have a great interest in immediate development of treatment devices such as a continuous, minimally invasive, real time, accurate whole blood glucose monitor as well as better, faster insulin activation. At age 81, I can't wait too long to benefit from long term biological cure development and most of the 26 million or so diabetics would also benefit from better control now. After all, the DCCT trials indicated that a 7% HbA1c would reduce complications by 70% not 100%. A recent issue of Diabetes Forecast showed that over 80 glucometers and 8 insulin pumps are available that all do essentially the same thing. I'm glad that we are the source of profit for the industry. How do we get R and D like that of the cell phone industry but not just profit driven? Jim West [email protected] 817-454-9532
I am a 32 year type 1 brittle diabetic and have heard of studies to try out bcg to reverse this aweful disease. I would love to find a trial near me in s.w. Florida. I would welcome and fully commit to it.
Sean, visit the link in the article to see more about enrolling
The director of the Massachusetts General Hospital Immunobiology Laboratory, Dr. Denise Faustman at the 75th Scientific Sessions of the American Diabetes Association (ADA) on Sunday announced that the US Food and Drug Administration (FDA) has approved a phase II trial for reversing Type I diabetes using BCG vaccine shots.