Diabetes Vaccine Study

Protocol Description

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.

Eligibility Criteria

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

Requirements

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.
Visits: 23
Duration: 1 year

Status: Open for Enrollment

Source(s) of Support

University of Pittsburgh

Additional Information

Study Description at National Institutes of Health
Article in Science Daily

Primary Investigator

Nick Giannoukakis, PhD
Theresa Whiteside, PhD
Silva Arslanian, MD

Contact Information

To get started, please contact:
Brian Copeman, BA CRTT
412-692-9156