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Stem Cell Educator Therapy in Type 1 Diabetes

This study is currently recruiting participants.
Verified October 2012 by Tianhe Stem Cell Biotechnologies Inc.
Sponsor:
Collaborator:
Chinese government fundings
Information provided by (Responsible Party):
Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01350219
First received: May 3, 2011
Last updated: October 19, 2012
Last verified: October 2012
History of Changes

May 3, 2011
October 19, 2012
September 2010
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01350219 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Stem Cell Educator Therapy in Type 1 Diabetes
Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
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 8 ~ 9 hrs.
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.
Intervention: Device: Stem Cell Educator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
14 Years to 60 Years
Yes
Contact: Yong Zhao, MD, PhD 630 723 1968 yzhaowhl@yahoo.com
China,   Spain
 
NCT01350219
2010-037
Yes
Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
Tianhe Stem Cell Biotechnologies Inc.
Chinese government fundings
Study Chair: Yong Zhao, MD, PhD Tianhe Stem Cell Biotechnologies Inc.
Tianhe Stem Cell Biotechnologies Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP