Stem Cell Educator Therapy in Type 2 Diabetes

University of Illinois

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Device: Stem Cell Educator

Study type: Interventional

Funder types: Other

Identifiers

NCT01415726

2011-010

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Cord blood stem cell

Experimental group

Description:

Human cord blood-derived multipotent stem cells (CB-SC) display unique phenotypes, such as the expression of embryonic stem (ES) cell markers, multipotential of differentiations, very low immunogenecity, and immune modulations. Stem Cell Educator will be used for isolation and purification of cord blood stem cells for the treatment.

Treatment:

Device: Stem Cell Educator

Stem Cell Educator

Experimental group

Description:

used for the isolation and purification of cord blood stem cells.

Treatment:

Device: Stem Cell Educator