Stem Cell Educator Therapy in Type 2 Diabetes

University of Illinois at Chicago25 enrolled

Overview

Type 2 diabetes is the most common form of diabetes. The prevalence of diabetes has been markedly increased in recent years. More and more children and young adults develop this devastating disease. Despite of multiple factors (e.g., food, environmental, and genetic factors) contributing to the developing of diabetes, increasing evidence demonstrated that chronic inflammation and/or atuoimmunity are common issues and play key roles in the pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of insulin-producing islet beta cells. Thus, anti-inflammation is becoming a novel approach for the treatment of type 2 diabetes. Evidence that multipotent stem cells derived from human cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers promise for a new approach to treat type 2 diabetes. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem Cell Educator therapy in T2D patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 6 \~ 7 hrs.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association 2010. Other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells for the autoimmune-related type 2 diabetes. Exclusion Criteria: * Exclusion criteria were any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Outcomes

Primary Outcomes

Inflammation control

Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers.

Time frame: 30 days post treatment

Secondary Outcomes

Metabolic control

Before treatment, test for HbA1C levels as baseline; After treatment, test HbA1C levels on the 3rd month

Time frame: 3 months