Stem Cell Educator Therapy in Diabetes

Abstract

Stem cell educator (SCE) therapy circulates a patient’s blood through a blood cell separator, briefly co-cultures the patient’s immune cells with adherent cord blood stem cells (CB-SCs) in vitro, and returns only the “educated” autologous immune cells to the patient’s circulation. Several mechanistic studies with clinical samples and animal models have demonstrated the proof of concept and clinical safety of the SCE therapy. They suggest that the SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages when these are exposed to the autoimmune regulator protein (AIRE) in the CB-SCs. In this project, the optimized SCE therapy for type 1 diabetes (T1D) and T2D will be tested in a prospective, single-arm, open-label, single-center study to assess its clinical efficacy and the related molecular mechanisms in patients with diabetes.

Department of Endocrinology, Chinese PLA General Hospital, Beijing, China

ClinicalTrials.gov Identifier: NCT03390231