Research

Diabetes Vaccine Study

Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety 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 of Support
University of Pittsburgh

Additional Resources
Study Description at National Institutes of Health
News Release Announcing Groundbreaking Research  
Article in Pittsburgh Post-Gazette
Pittsburgh Tribune-Review Article
Article in Science Daily

Primary Investigator(s)

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

Contact Information

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

Last Update
June 25, 2014
  • Increase/Decrease Text Size
  • Print This Page
Last Update
June 25, 2014
top