This is the
most exciting news I've had since my diagnosis with diabetes 25 years ago.
Today ClinicalTrial.gov posted a
trial announcement looking for people to participate in the first trial for a possible cure for type 1 diabetes. This is based on the research led by
Dr. Denise Faustman over the last decade.
To quote the site "This is the first step in trying to cure established type 1 diabetes". Tell me that's not a big thrill.
When I spoke with
Dr. Faustman in January, she was hoping that they could trial this approach with relatively small numbers of people. It seems she was successful, they are looking for 25 subjects to participate in this trial. Dr. Faustman mentioned that the early trial would be used to try and establish basic dosing information and determine whether the approach actually works in people.
As usual for this type of trial there will be two groups of participants, some taking
BCG and others taking saline as a placebo. You would receive an inoculation at the start and at 4 weeks into the trial. It's a
double blind trial. Neither your nor the investigators will know who's receiving which substance.
BCG has been used for many years as a vaccination for tuberculosis. It's also used in immunotherapy for cancer and other diseases. It's low cost, approximately $3 for a tuberculosis vaccination. It's also not 'owned' by a specific pharma company, so it should be readily available.
I would sign up for this trial today...but I don't qualify. My age and previous inoculation with BCG exclude me. I do hope that's not always the case.
If you're thinking about it, please take a close look at both the inclusion and exclusion criteria. There are a
lot of these.
We're definitely living in exciting times.
Labels: bcg, cure, diabetes, faustman
Meeting Dr. Faustman
In early January I visited the Mass General Hospital
research lab where Dr. Denise Faustman is leading research into a possible cure for type 1 diabetes. I was there to give a blood sample for use in this research.
If you've ever met someone you've admired for a while, or maybe a rock or movie star, then you'll know how I felt as I spent time with her.
Over the last two years I've taken part in two bike rides to raise funds for this research. But now I had a chance to actually help support the research in a more direct way.
The lab is drawing samples of blood from people with type 1 diabetes, and 'healthy' volunteers. Because they're having trouble getting healthy volunteers, they ask everyone with diabetes to bring a volunteer with them. These folks must not be directly related to you, and not have any auto-immune diseases. I was fortunate that a friend of mine from work kindly offered to come with me. Paul is one of the founders of the
yard sale search site GoYarding.com.
I met Dr. Faustman early in the morning. They do all the sample collection early in the morning so it doesn't interfere with work and school schedules. While we talked, she collected four test tubes of blood from me. She explained that some of this blood was tested using machinery they're developing and some was tested manually by one of the researchers. I believe that manual testing takes about one day to complete.
They're trying to accurately measure the amount of
T cells that I have. Her theory is that these T cells are responsible for destroying my insulin producing
beta cells. These cells also produce
amylin. This is now available as an injectable drug called Symlin that I've written about
several times.
You can see a short video of Dr. Faustman and an animation of how they believe the T cell process works on the
Iacocca Foundation website.
Some of the blood is also sent to another research lab. They have a method for measuring autoantibodies in blood. She explained that autoantibodies are produced when beta cells are destroyed. So if these were found in my blood, that would indicate that my body had recently lost some beta cells. Which would mean that my body is
still making beta cells, 35 years after I first got diabetes.
She hopes to start trials before too long where they will be administering low doses of
BCG to see if this can destroy these T cells. BCG is used in Europe as an inoculation against tuberculosis, and is also used as an
immunotherapy treatment for bladder cancer.
BCG has been around for a long time. As it's already approved for use as a medical treatment, it is
likely that getting approval to use this for other purposes will be quicker and easier than for a new drug. It will probably also be less expensive.
Dr. Faustman's hope was that the FDA would permit trials with low number of subjects. This makes it easier to administer the trials because getting enough people is always a challenge and testing the outcomes is easier with smaller numbers.
She explained that there will likely be several trials with increasing doses, so they can determine if it works, and at what dosage levels. Clearly having automated measurement machinery will make this process a lot faster. They've been working on developing this machinery over the last few years.
I told her that it would be wonderful if they started a blog, even a low-volume one to keep everyone informed about their progress. But she's concerned that will take away from research time and also that the blog may draw a lot of comments that would need to be read and handled.
I imagine the entire lab must feel a little like
Banting and Best after insulin was first discovered. They had hundreds of parents from around the world contacting them to try and get their children treated. And that was in the days before the internet and e-mail.
It was a real pleasure spending some time with Dr. Faustman and getting an update on their progress.
I have another appointment in September to get another blood draw. As Dr. Faustman pointed out, this is an easy way to get the latest news. And by then I hope to have completed another bike ride to support her exciting research. I can't wait!
Labels: bikeride, cure, diabetes, faustman, research
Brief update on Dr. Faustman's research
If you've read this blog for a while you may know that I've done
some fundraising to support the research by
Dr. Denise Faustman into a possible cure for Type 1 diabetes.
I'm subscribed to the
Yahoo! newsgroup about this work and today they posted a pointer to a brief
USA Daily article with a
small amount of news.
This is slow work and Dr. Faustman is conducting it in a careful and rigorous way. Which makes some of us impatient for results. But I'm eternally optimistic about it all.
In early January I'll be at the lab to get some blood drawn that will be used in the research. A good friend from work will also be there as a healthy volunteer! What a guy. While I'm there I hope to meet with Dr. Faustman and ask her some questions about the work. I'll post what I learn online (mid-January).
Updates: I did meeting with
Dr. Faustman in January. In March there was an announcement about the start of
clinical trials for a possible cure for type 1 diabetes, based on her work.
Labels: cure, faustman, research, update
