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Stem Cell Educator Therapy in Type 1 Diabetes
This study is currently recruiting participants.
Verified September 2010 by University of Illinois

First Received on May 3, 2011.   Last Updated on May 6, 2011   History of Changes
Sponsor: University of Illinois
Information provided by: University of Illinois
ClinicalTrials.gov Identifier: NCT01350219
  Purpose

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.


Condition Intervention Phase
Type 1 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: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources

Further study details as provided by University of Illinois:

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


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

  • Analysis of islet beta cell function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    1. Test for C-peptide levels on the 6th month;
    2. Full evaluation of islet beta cell function after one year.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (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.
 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 60 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.

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: NCT01350219

Contacts
Contact: Yong Zhao, MD, PhD 312 996 7989 yongzhao@uic.edu

Locations
China, Shandong
General Hospital of Jinan Military Command Recruiting
Jinan, Shandong, China, 250031
Contact: Zhaoshun Jiang, MD     86 13953104251        
Sponsors and Collaborators
University of Illinois
Investigators
Study Chair: Yong Zhao, MD, PhD University of Illinois
  More Information

No publications provided by University of Illinois

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet β cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3.

Responsible Party: Yong Zhao / Assistant Professor, UNIVERSITY OF ILLINOIS AT CHICAGO
ClinicalTrials.gov Identifier: NCT01350219     History of Changes
Other Study ID Numbers: 2010-037
Study First Received: May 3, 2011
Last Updated: May 6, 2011
Health Authority: United States: Institutional Review Board
China: State Food and Drug Administration

Keywords provided by University of Illinois:
Cord blood stem cells
Immune modulation
Stem cell educator
 Autoimmunity
Islet beta cell regeneration
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012



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