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BCG vaccine trial results announced for reversing type 1 diabetes

Kathleen Blanchard's picture
BCG vaccine for type 1 diabetes
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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]

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Updated: April 18, 2014
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Comments

My husband was a Type 1 diabetic for 25 years and passed away from complications of diabetes. I am so happy to hear that there is something out there that will do the job in reversing this horrible disease.
I ran across this article on Facebook and also passed it on to a fellow college friend who is type one. I have been a type one for 31 years and was diagnosed at the ripe old age of 10 years old. The first 5 - 7 years with the disease were the hardest. When I was diagnosed, I weighed 98 pounds and after I was diagnosed, the weigh piled up on me. I've had DKA every year for those first 5 - 7 years because I was a teenager and wanted to be thin again so I wouldn't take my insulin for months at a time. I'd go to the hospital with DKA and gain that weight back plus more! I got to college and straightened up my act and I've been straight ever since. So now, at 41 years old in 3 days, this is very good news to hear. I have my share of complications but no one would know it by just looking at me! I take MANY MANY medications to ward off the complications. They are with me but at least my ENDO is trying to slow them down. I've been on a pump for the last 12 years and it's the best thing ever along with my CGM for the last 4 years and my HA1C has been 6.2 for the last two years! The combination of the two devices "was" the best thing ever until I saw this article. It may be too late for me but save those who have Type One from this day forward! People who are uninformed about Type One's always say, "OH! You have the bad diabetes!" The ignorance kills me!!! Then I tell them that it's an auto-immune disease and that one form of diabetes is no worse than the other, it's how you take care and manage it that counts! IF this drug can wipe out type one diabetes and the ignorance about it, that would be a great relief in itself!
More informationi needs to be given. As much as we are looking for hope in prayer, this is only 7 people tested on and who is the FDA? Many false hopes have been squashed with our drugs that later prove to have severe side effects and end dup with other severe complications. My neighbor was on a diabetic 'research' program and got all of her medications for 'free' and succumbed to cancer that was all over her body. Look at the lawyers now advertising for 'bad drugs.' Little hope is better than no hope, but sometimes the research is not always the whole truth. Where did these 7 people come from also and how long have they been followed by the FDA. I have tried to find out products that should be governed by the FDA and they are a government institution that can be found where? Try and find out where the studies are from the FDA on an MRS2000 unit that can cause 'seizures.' Who studied this unit before it was released in the US? Know the people you trust, not just the abbreviation.
This here, I can not wait to see the light of day. This is a dream for all of us.
I have had Type 1 for 38 years. I would love to be in this clinical trial. Where can I sign up?
I was diagnosed with type 1 diabetes when I was 15 years old and now I am 30 years old. I'm on a insulin pump my A1C ranges 6.7-7.4. My eyes and kidneys are not showing signs of abuse from it yet. My cholesterol is abit high and I have broken two toes. I have had jaw surgery. Everything has healed properly. I want to be a volunteer or be a candidate for this study too.
I have been diabetic since i was thirteen. I'm twenty six now so i have been living with it for over a decade. I would love to participate in this study!
This is great to read an will be even better for those of us who do suffer this horrible disease. I've been type 1 since just after my 21st birthday, i'm 27 now and everyday i, like many others, do the daily checks and its tiring and i just want to maybe go back to how my life was before this. Keep up the good work!
I have been a diabetic for fourty two years this Christmas. I have always prayed that there would be a cure. I am so excited to hear that it is closer to being done. I would like to be a patient for help with this if needed. God Bless you in doing all of this.
I would like to say that I just found out I have type 1 diabetes. I was diagnosed at 21 and I will be 23 this Dec. I already have damage to my body due to the fact that I didn't know I had diabetes until I went into DKA. my sugar was 1400! Crazy. I would love to be a participant for this Vaccine. Thank you!
I have been type I for 12 years, diagnosed @ 30 and my ten year old daughter was diagnosed type I a year and half ago. My hope is for to not have to worry or deal with the long term complications. I hope with all I have this is a breakthrough we've been waiting for! We are in Washington State near Seattle, but if we can help with research please reply with who we should contact! Thank you!
I have had Type 1 for 29 years and am on a pump, I would be so grateful for a chance to help and be cured , thank you !!
I have had diabetes since age of 13 months old. Was on 4 shots a day till I went to insulin pump at age 15. I am now 43. I am anxious to see any days of not having diabetes. I have a question. I was under the understanding that the pancreas did not produce enough insulin. In this article, it seems to read that the pancreas produces, but is attacked by other cells. Can you explain this and what is the cause in diabetes Type 1? Thank you !! Hope this research works for all diabetics and not just those with no other complications or having certain complications. Thank you for your time money and work !!
The last comment I see is dated January 2013. Have there been any since then? I am extremely interested in this study. I am almost 52 & have been T1 diabetic since age 10. I have had or have nearly every complication related to this deadly disease. My brother is also T1; he is 48 & was diagnosed at age 2. I/we are extremely interested in any & all info on this study including possible involvement in the study. This would be a dream come true for us & our family.
I hope this is a great brakethrough I have had type 1 for 29yrs and been in DKA 7 times almost died from it and I've lost one daughter because of my diabetes ill be a tester or supporter any thing to help
I've had type 1 diabetes for 12 years and it has been a terrible lifestyle. I would love to participate!
my daughter is 14. shes was diagnosed 3 years ago. We still havent found an insulin that will balance her blood sugar, she now has highs that put her up in the 600-800s on occasion, which hospitalizes her for days, causing her to miss her school work. please contact me if we may be of assistance
My son 25 and my 4 yr old grandson has type 1 diabetes.o please sign us up.I pray that we finally have a cure for this really bad disease.have my prayers really come true.I'm so excited.Thank you so very much.looking forward to your reply..
I was diagnosed with Type 1 diabetes 36 years ago at age of 3 I'm now 39. I have said that they more and likely would not come up with a cure in my life time. I would love to live with out having to make sure that I took my insulin before eating. If you need people to volunteer I'm.
My brother and I both have type 1 diabetes even though no one else that we know of in our family has it. We were both diagnosed at age 14, me in 2002 and my brother in 2003. All very mysterious, as is much of this disease, which is why when I hear about this kind of progress being made I am so very thankful! I am so excited to read and find out that there is hope out there! :)
I have had Type 1 for 49 years. My son, age 27 was just diagnosed with Type 1 this past June. If not for me, I would like to see a cure for him someday. I'm sure we have a long way to go, but this information gives me hope as I know that people are working on it. thanks to the Iaccoca family
Any chance for a close cure for type 2?
Not sure if this post helps us get into this study,but I been type one 15 years and been told I have no beta cells left in my pancreas wondering if I qualify I have so many complicated medical problems and is would give me the chance to life to see my great granddaughters
So many wonderful comments! This link that is at the end of the story is where you must go for updates: http://www.faustmanlab.org/. Sign up for their mailing list also. Spread the word too. What is needed is funding. They have raised money but need more. Lack of research funding, just so everyone knows, is one of the biggest hurdles for advancing medical knowledge that can lead to new treatments.
My son is 20 and is a type 1, he was diagnosed late in 2009. It's been a struggle, he has been hospitalized many times for diabetic ketoacidosis. This brought tears to my eyes as well, to imagine him not having to deal with all he has had go deal with. He would be a great participant. He has such a good outlook on life and has takin it all in stride. It would mean so much for him and every diabetic that deals with everyday struggles. God Bless those who have these daily struggles and God bless the ones working on this!! I will continue to pray this happens!! Thank you for what your doing!!!
My daughter has had diabetes for eight years. We are very interested in thid vaccine, and would love to participate in clinical trials.
I would love to be rid of diabetes, would love to be a participant. Thanks
i have had diabetes for the past 22 years and would love to get in on the action. please let me know when this info and or study or procedure comes to South Africa.
This amazing breakthrough will be shelved just the same as many other breakthroughs that would allow for cures to chronic illnesses that require continual medications. Remember, our government controls what is authorized and what is not. Lobbyists pay our congressmen to vote the way that they want them to. The larger corporations are the ones whom send these people to Washington to vote against allowing these things to be accepted by the FDA. Classic example, stem cells. If there is a finding that will allow for cures to these diseases, these companies will be out of business. They are basically paying politicians to keep people sick so they can continue to make billions off the sick and dying public. I've been praying for years to and am usually pretty positive, but not after what I've seen in my adulthood from our society. I am 45 and am type 1 for 34 years. I will continue to pray though.
Don, there are honest researchers working hard to find cures. They do what they do because they want to see cures. Many are not affiliated with drug companies.Yes, the FDA must approve treatments and that can be a hurdle. But when any clinical trial meets its end point goal, they cannot squelch that. Please don't believe that. If you could see the dedication of physicians and nurses at the NIH for instance who work with patients with new treatments you would have renewed faith.

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