Type 1 diabetes immune therapy to undergo human trials
A therapy that aims to modify the immune system to hold back the development of type 1 diabetes is to undergo human trials early in 2015.
The therapy involves a combination of two drugs, each that have been approved by the FDA for the treatment of other conditions. One of these drugs is anti-thymocyte globulin (ATG), a drug that has been used to reduce rejection of organs, such as the kidneys or bone marrow, following transplantation. The drug reduces the number of killer T cells, which are the cells which are responsible for killing the insulin producing cells in the development of type 1 diabetes.
The other drug in the combination treatment is granulocyte colony stimulating factor (GCSF), a drug that increases the number of immune regulatory T cells. GCSF is used along with chemotherapy in cancer patients to increase white blood cell count. The use of GCSF in mice studies has previously been shown to prevent the development of diabetes.
The human trials will involve 28 participants that will take the combination treatment, 28 patients that will receive only the ATG treatment and another 28 participants who will take a placebo. All patients will have newly diagnosed type 1 diabetes and will not be aware of which treatment they are on.
The research builds on previous research into the effects of ATG treatment alone, which showed promise but not enough success to meet the target for effectiveness. By studying ATG treatment alone and with the additional GCSF therapy will give the researchers the chance to assess whether GCSF does indeed increase the effectiveness of the ATG treatment.
The trial will last 12 months and is being supported by the JDRF and the American Diabetes Association. The study is being carried out by the University of Florida.
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