Stem Cell Educator (SCE) therapy circulates a patient's blood through a blood cell separator, briefly cocultures 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 SCE therapy. They suggest 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 related molecular mechanisms in patients with diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
It briefly cocultures the patient's lymphocytes with CB-SCs in vitro, induces immune tolerance through the action of autoimmune regulator (AIRE, expressed by CB-SCs), returns the educated autologous lymphocytes to the patient's circulation, and restores immune balance and homeostasis.
Department of Endocrinology, Chinese PLA General Hospital
Beijing, China
RECRUITINGChanges of inflammation-related markers in diabetic patients after Stem Cell Educator therapy
After treatment for 30 days, diabetic patients will be tested for inflammation-related markers (e.g.,Th1/Th2 cytokines) by flow cytometry and compare with the baseline levels.
Time frame: 30 days
Change in insulin resistance
Before treatment, test for insulin sensitivity by chip analysis as baseline; After treatment, test sensitivity levels on the 1st month.
Time frame: 30 days
Metabolic control in HbA1C levels
Before treatment, test for HbA1C levels as baseline; After treatment, repeat these testing on the 3rd month. Hemoglobin A1c (HbA1c) will be reported as the changes in percentage.
Time frame: 3 months
Metabolic control in blood glucose levels
Before treatment, test for fasting glucose as baseline; After treatment, repeat these testing on the 3rd month. The blood glucose level will be measured as mMol/L.
Time frame: 3 months
Metabolic control in fasting C-peptide levels
Before treatment, test for C-peptide levels as baseline; After treatment, repeat these testing on the 3rd month. C-peptide will be measure as ng/mL.
Time frame: 3 months
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