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This Phase I clinical trial is being done to evaluate the safety and feasibility of a treatment for type 1 diabetes in which dendritic cells (a type of white blood cell) are removed from study participants, modified in the laboratory and re-injected into the participants. In mice it has been shown that this type of diabetes-suppressive cell vaccine successfully inhibits the interaction and destructive effect of “T cells” (lymphocytes) on the insulin-producing cells of the pancreas. If this study proves that the treatment is safe, more studies will be done to see if treated dendritic cells will protect insulin-producing cells.
Subject to certain exclusion criteria, the study is open to men and women, ages 18 to 35, who have been diagnosed as having type 1 diabetes for at least 5 years and who are in good health with no diabetes complications.
Males: ages 18 to 35
Females: ages 18 to 35
Participants will have dendritic cells (a type of white cell) removed from the blood in a 2- to 4-hour hospital procedure. For about half of the study participants, dendritic cells will be modified with substances that may enable them to inhibit the destruction of insulin-producing cells in the subjects. The dendritic cells of the remaining participants will not be treated. For the following 6 weeks, the dendritic cells of study participants will be injected back into them subcutaneously, with no need for anesthesia. All subjects will be monitored for side effects over a 12-month period.
Duration: 1 year
University of Pittsburgh
Study Description at National Institutes of Health
Article in Science Daily
Nick Giannoukakis, PhD
Theresa Whiteside, PhD
Silva Arslanian, MD
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Brian Copeman, BA CRTT
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