Personal Experience with New T1D Study

December 14, 2009

I am just now back from a trip to Boston MA to participate in the Dr Faustman’s Bacillus Calmette-Guérin (BCG) study. The first way into her study was to donate blood for research. I donated 6 vials of my blood and brought along my partner in crime, JR, because he is not related to me and because he does not have any type of autoimmune disease. They also took 4 vials of his blood- as a control study.

Dr Faustman’s research is break-through because it is studying ways to cure Type 1 in people who are CURRENTLY LIVING WITH THE DISEASE- not for those who are newly diagnosed. When I spoke with Dr Faustman on the telephone on Wednesday, December 9th, she was clear (and very happy) that she wanted to help those that are already living with the disease. She understood that there are many people living with Type 1 and that back at diagnosis, maybe there weren’t many options available for cures back then. Maybe we weren’t informed about the cure research organizations back at diagnosis. The window for treatment is so small- about 6 months after diagnosis.

So, Dr Faustman is using her knowledge and her studies with a drug already in use for over 80 years, called BCG. BCG is used currently for tuberculosis immunizations in other countries. It is a generic drug that temporarily elevates TNF levels in the body, and will reduce or eliminate autoimmune T cells in patients with type 1 diabetes. Without the T cells that are destroying (smothering / inhibiting) the pancreas, the pancreas is believed to begin producing insulin once again.

Dr Faustman believes that the pancreas in Type 1 Diabetics is not dead, but suppressed. She believes that once the T cells are reduced, the pancreas will begin to produce its own natural insulins once again, and the body will return to normal fuctioning.

An injection of BCG will last only an allotted amount of time in the body. The length of time the person will remain diabetes free depends on the amount of BCG administered, as well as the response to the drug. This time frame could be from 6 months to 6 years. Since the killer T cells are an autoimmune disease, they will return. When they return, another administration of BCG will need to take affect to return to a diabetes free state.

Blood donation appointments need to be made to participate in this study. The appointments are in high demand and are currently scheduling out to August 2010. (I had to wait 5 months to be seen this past December 10th) If you are not from the Boston area, there are many sites to be seen and many things to do in the area- should you decide to make it a two or three day hotel room stay. I recommend the Hilton on Boylston St. It is within walking distance of the mall as well as many many boutique stores and supermarkets. The museums are beautiful and the convention center is basically downstairs. Dr Faustman’s lab is within 10 mins driving distance from the Hilton and parking is free if tickets are booked online on

Phase I trials are closed. It is the part of the study that is proving that the drug is safe. Some patients are receiving small doses of BCG and some are receiving placebos and they are comparing to see if there are any changes caused to BCG other than lowered insulin dosages.

Phase II studies are still open and are based upon your compatibility results from your blood donation.

Please take the time to look at her website: and consider donating your blood or monetary funds. Her entire research project is public supported and needs all the assistance you can offer.

Spread the word.

Now that we are more than 12.000 TuMembers I really wondered if anyone is participating in the BCG trials - and here you are. I am glad that you are investing some of your spare time for this project. The research that is done here is fundamental to understand the mechanisms of T1 developloment. However the outcome a medication that is able to amplify or moderate the rogue T-cells will lead to knew insights and is a path to follow. If the medication is dosed right the rogue T-cells should even disappear like it has happened in mice. This would be a tremendous breakthrough. Then time will tell if insulin producing cells in humans can recover from years of suppression by the immune system. I am pressing my thumbs…

Tx, nicely written update on Dr. Faustman’s great effort.

Yes! When I talked to her on the phone, I was in tears when she said that the pancreas would begin NATURALLY producing insulin once again. omg, to have a NORMAL body again. I have forgotten what it felt like!

This is very emotional indeed and I hope you can manage to lower your expectations a little bit. It is really a good shot at the core but we have to be patient…

everybody keeps saying that. :slight_smile:
I know ya’ll don’t want to see me get hurt, but I don’t think it’s a bad thing to hope and dream. To soar and then plummet when the parachute breaks, if need be. It’s ok to be excited. haha.

Thanks Danny. I just read hers and posted a response. :slight_smile:

I’m recently diagnosed but there are no cures now as you seem to imply. I’m in a research study where I have a 2/3rds chance to get stem cells, but it will only give a temporary effect like what you described concerning the study you are in. At very best I can hope for about 4 years of being insulin free, and I’d have to be very lucky for that.

Hi Robert-

Yes, currently there are no cures for Type 1 diabetes.

Most research projects deal with the newly diagnosed because at that time the pancreas is still in its “honeymoon” phase where it’s still producing tiny spurts of natural insulin.

However, people like me, who were diagnosed years and years ago (before there were clinical trials) don’t fall into this group anymore. That’s why Dr Faustman’s study is so breakthrough. Because she’s including those of us who missed the “newly diagnosed” phase and missed out on a chance at a “normal” life.

I wish you so much luck and a strong immune system to keep those infections at bay and keep your resistance down. There are a few of you on this forum. I was talking to a girl who was “cured” about a year ago. She entered into a research study for newly diagnosed too, and she has been off insulin for a year and going strong.

Very excited for you, Marps!. Also excited for the rest of us. Dr. Faustman’s work is thrilling since it involves an existing drug.

I signed up for clinical trials shortly after diagnosis, but never got called. All were great distances away, but I was hopeful.

You can donate to her if you’re not too far away! Her trials are still open and pending. I’m going back to donate more blood in August. Even if I don’t get called to the Phase II trials (where I actually would get to test the drugs out myself), then atleast I’m helping them with my blood donations. I’m a first generation Type 1 so I’m hoping that my DNA shows the genetic mutation that caused this mess. :slight_smile:

Quick question if anyone can answer it: Does this drug specifically attack only the T-cells which are suppressing the pancreas’ ability to produce insulin or does it have an effect on the overall number of T-cells? It sounds wonderful but the downside of a possibly weakened immune system would well, suck.

Because a low T-cell count would be like having HIV.

from her site:
In 2001 and in 2003, the results of the Faustman lab’s experiments in end-stage diabetic mice were published. The results showed that a brief, 40-day treatment selectively eliminated the disease-causing white blood cells in end-stage diabetic mice. This treatment killed only the cells that were causing the autoimmune destruction, and not the healthy cells. These experiments also uncovered the ability of the pancreatic islets to regenerate without the introduction of any live cells once the cells that were causing the autoimmune destruction were eliminated and the autoimmune disease was stopped. The Science paper also identified a new source of adult stem cells- adult stem cells in the spleen- that could form new islets in the formerly diabetic animals. In the human trials, no spleen cells will be used.

from her site:
Current diabetes treatments attempt to replace the insulin that is either not produced or not produced in sufficient quantities by the body; they do not reverse or eliminate disease. Dr. Faustman’s work represents a reversal of diabetes, rather than just a treatment for the symptoms and complications of this disease. Dr. Faustman’s research suggests it may be possible to stop the destruction of insulin-producing cells as the first step in the reversal of diabetes. Not only does this research have significant implications for the future of diabetes treatment, but it also has the potential to impact the treatment of other autoimmune diseases, including rheumatoid arthritis, multiple sclerosis, Crohn’s disease and lupus. Worldwide research efforts have discovered evidence of genetic and white blood cell errors in these human autoimmune diseases similar to those seen in type 1 diabetes.
And like HIV, T1D is actually an AutoImmune Deficiency(AIDS).

Thanks, that perfectly answered my question. :slight_smile:

Ellen – yes, it specifically targets the T cells that cause diabetes. Faustman’s work is really interesting and the method she’s used from the beginning has followed a very logical progression. She identified the T cells that attack the beta cells. In fact, she directly measures them during her human clinical research. What’s interesting in all the T cells that she’s identified that cause autoimmune disease is that they are abnormal – each differently for each disease. The T cells that attack the beta cells have a defect in a biochemical pathway. TNF – what the body produces in response to BCG – kills those T cells, but doesn’t affect healthy T cells. So, it’s a selective way of removing them and has no impact on the function of the immune system. And best of all, it’s a way of removing the cause of type 1.

I recently launched a new group of parents of children with type 1 and we are choosing the research projects that we feel have the most promise for a treatment and eventual cure for type 1 – we also ask people to donate directly to the research institution, so that the money all goes for the research. That way, we have control over where our money goes. We have a video on the front page that gives a bit of background of Faustman’s work in terms we hope will help people understand the basic principals. We also have a page that explains her research and there are lots of really good links listed at the bottom. The FAQ gives some info about the funding environment and why the public is funding her work. So, take a look. I’m not an expert, but I’ll try to answer any specific questions I can about her research.

We parents are on a mission to contribute as much money as we can towards Phase II funding. The focus for our group is kids, though we of course realize that kids with type 1 grow into adults with type 1 and that people can develop type 1 at any age. I’m thinking about making a section that profiles adults with type 1, that is similar our “Meet the Children” section. Does this interest anyone?

Marps (and all the others who participated): On behalf of all of us, THANK YOU!!!

I hope that good news will come out of the research that you participated in!

I would be interested in profiles for adult who were dx’ed as adults. I am one of the late ones. I was dx’ed aug./08, type 1 at age 52.

Faustman’s trials are safe because it would only target particular rogue T-cells in the bloodstream, not effecting the pt’s immune system in general. However, my endo, who is also a researcher, warned me that the rogue T-cells Faustman is targeting are not going to cure most Type 1s, even if her research is successful. She said not all Type 1s have the particular rogue T-cells Faustman is targeting. In other words, 30 to 40 percent of Type 1s have the particular rogue T-cells that BCG targets. The other 60 to 70 percent have OTHER TYPES of rogue T-cells that BCG will have absolutely no effect on. Curing even 30 to 40 percent of patients is HUGE, absolutely, but Faustman’s cure is not a cure for every Type 1. Not to mention that even if you eliminate the evil Tcells from the bloodstream, the spleen and thymus could release more of the same. Not worried about that as much, because I imagine you could just get a “booster” every year. BCG is an available and inexpensive drug.