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Stem Cell Educator Therapy in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Chinese government
Jinan Tianhe Stem Cell Biotechnologies Co Ltd
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT01415726
First received: August 10, 2011
Last updated: February 16, 2012
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Device: Stem Cell Educator
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Inflammation control [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers.


Secondary Outcome Measures:
  • Metabolic control [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Before treatment, test for HbA1C levels as baseline; After treatment, test HbA1C levels on the 3rd month


Enrollment: 25
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cord blood stem cell
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.
 Device: Stem Cell Educator
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.
Experimental: Stem Cell Educator
used for the isolation and purification of cord blood stem cells.
 Device: Stem Cell Educator
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

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415726

Locations
China, Shandong
General Hospital of Jinan Military Command
Jinan, Shandong, China, 250031
Sponsors and Collaborators
University of Illinois
Chinese government
Jinan Tianhe Stem Cell Biotechnologies Co Ltd
Investigators
Principal Investigator: Yong Zhao, MD, PhD Universtiy of Illinois at Chicago
  More Information

Publications:

Responsible Party: Yong Zhao, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01415726     History of Changes
Other Study ID Numbers: 2011-010
Study First Received: August 10, 2011
Last Updated: February 16, 2012
Health Authority: China: Ministry of Health
China: Food and Drug Administration

Keywords provided by University of Illinois:
Cord blood stem cells
inflammation
type 2 diabetes
 stem cell educator
autoimmunity
immune modulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013