Phase I (Safety) Study of Autologous Tolerogenic Dendritic Cells in Type 1 Diabetic Patients

• DOI: 10.2337/dc11-0472
• Publication Date: 2011-06-17T22:54:48Z
• Authors: Nick Giannoukakis; Brett Phillips; David Finegold; Jo Harnaha; Massimo Trucco
• Keywords: CD11c; Ex vivo; Hematology

The safety of dendritic cells to selectively suppress autoimmunity, especially in type 1 diabetes, has never been ascertained. We investigated the autologous cells, stabilized into an immunosuppressive state, established adult diabetic patients.A randomized, double-blind, phase I study was conducted. A total 10, otherwise generally healthy, insulin-requiring patients between 18 and 60 years age, without any other known or suspected health conditions, received unmanipulated engineered ex vivo toward state. Ten million were administered intradermally abdomen once every 2 weeks for a four administrations. primary end point determined proportion with adverse events on basis physician's global assessment, hematology, biochemistry, immune monitoring period 12 months.The safely tolerated. There no discernible patient throughout study. Other than significant increase frequency peripheral B220+ CD11c- B mainly seen recipients during cell administration period, there statistically relevant differences populations biochemical, hematological, biomarkers compared baseline.Treatment native state directed tolerogenic is safe well Dendritic upregulated potentially beneficial B-cell population, at least diabetes autoimmunity.