Stem Cell Educator Therapy in Diabetes
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Stem Cell Educator, Immune modulation, Diabetes, Autoimmune, Insulin resistance, Pancreatic islets
Eligibility Criteria
Inclusion Criteria:
- Patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.
Exclusion Criteria:
- Exclusion criteria are any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
Sites / Locations
- Department of Endocrinology, Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Stem Cell Educator
The Stem Cell Educator (SCE) technology involves a closed-loop system that circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent CB-SCs in vitro, and returns only the "educated" immune cells to the patient's circulation. Several mechanistic studies with clinical samples and animal models have been conducted to demonstrate the proof of concept and clinical safety of SCE therapy. They suggest that SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages that are encountered through the action of the autoimmune regulator (AIRE) and other molecular mechanisms. Following induction of immune tolerance in the immune cells, the immune balance and homeostasis may be restored when treated cells are returned in vivo.