Polyclonal Tregs Starts a Phase-I Clinical Trail
This one is a little complex. The body's immune system includes T-regulatory cells, which help control the "killer" T-cells which (in type-1 diabetes) mistakenly attack the beta cells. Some researchers have attempted to reduce the number of "killer" T-cells, while other researchers are trying to raise the number of T-regulatory cells. This research is trying to raise the number of T-regulatory cells. The basic technique is as follows: remove some of a patient's own T-regulatory cells, which is the same processes as giving blood. Then separate and purify those T-reg cells, and grow them for about 2 weeks. You can end up with 1000 times as many as you started with. Finally, put them back into the patient. Since these cells naturally regulate (or control) the body's immune system, having more of them may result in the body stopping it's own autoimmune attack. They've had good results in NOD mice. Finally, some researchers believe that the previously seen good results in some other treatments (such as anti-CD3 and ATG) might be caused by these treatments stimulating T-reg production, rather than, or in addition to, lowering "killer" T-cell production.
This study involves 14 people, who have had type-1 diabetes for more than 3 months, but less than 2 years. It is primarily a safety trial (to make sure the procedure is safe), but has secondary measures to also see if the treatment improves type-1 diabetes (for example: higher C-peptides, lower A1Cs, etc.). It is a single site study, being done at UCSF (San Francisco, California, USA). Dr. Gitelman ("Dr. Steve", if you attend Bearskin Meadows camp) is running it.
Unfortunately, this study will not be quick. It is expected to last until 2016.
Clinical trial record: http://www.clinicaltrials.gov/ct2/show/NCT01210664
UCSF's web page: http://www.diabetes.ucsf.edu/clinical-care-education/clinical-trials/type-1-diabetes/new-onset-type-1-diabetes-age-6-45-years-wit
Canakinumab Starts a Phase-II Clinical Trial
Canakinumab is a monoclonal antibody, which is designed to lower inflammation. It was approved in 2009 (both US FDA and EU EMEA) for a collection of rare autoimmune based inflammatory diseases. Good results have been seen in people with type-2 diabetes, and it has been used in children as young as 3. Therefore, it is known safe, and can start a phase-II trial for type-1 diabetes. The trial is for 66 people who will be followed for 4 years. It is honeymoon only (100 days from diagnosis). The treatment is monthly injections for a year: 2/3 get treatment, 1/3 get placebo. My general comments on inflammation based cures apply here: http://joshualevy.pbworks.com/w/page/24444346/ConceptsAndBackground#Inflammation
This is a large trial, recruiting in many locations in the US, which are listed in the clinical trial record below. For locals: both UCSF and Stanford are participating.
Clinical trial record: http://www.clinicaltrials.gov/ct2/show/NCT00947427
Wikipedia entry: http://en.wikipedia.org/wiki/Canakinumab
Data Published from extended follow up to Diamyd Phase-II Trial
Diamyd as published some extended follow up up data from their phase-II trials, which I have not had time to review, but you can see it here:
Full Paper: http://www.springerlink.com/content/k7051252031r1671/fulltext.html
Clinical Trial: http://www.clinicaltrials.gov/ct2/show/NCT00435981
Not Yet In Human Trials
There were several new types of artificial pancreas which I heard about in 2010, and this is the latest. It is called a "Bionic Pancreas" and is basically a dual-hormone (insulin and glucagon) AP, but designed as a single, custom computer chip. They hope to start human trials "this year ". These guys know about the dual-hormone work being done at Harvard, and the two groups are using some of the same ideas, but pushing different parts of the technology. The Harvard guys are focused more on exact algorithms, and these guys (at Imperial Collage, in the UK) are focused more on a single chip package.
News report: http://spectrum.ieee.org/biomedical/devices/bionic-pancreas
Not Type-1 Diabetes Related
The following article describes the ethical issues of a chemist who works with brain chemicals in rats, and who's work is often used by black marketeers to create street drugs, which sometimes kill people. It is an interesting read and an interesting moral dilemma.
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.