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Clinical Trials/NCT01415726
NCT01415726
Completed
Phase 1

Stem Cell Educator Therapy in Type 2 Diabetes

University of Illinois at Chicago1 site in 1 country25 target enrollmentJuly 2011
ConditionsType 2 Diabetes

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Illinois at Chicago
Enrollment
25
Locations
1
Primary Endpoint
Inflammation control
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
February 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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
  • 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

Time Frame: 30 days post treatment

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

Secondary Outcomes

  • Metabolic control(3 months)

Study Sites (1)

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