Stem Cell Educator Therapy in Type 2 Diabetes
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 17, 2012
July 1, 2011
7 months
August 10, 2011
February 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammation control
Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers.
30 days post treatment
Secondary Outcomes (1)
Metabolic control
3 months
Study Arms (2)
Cord blood stem cell
EXPERIMENTALHuman 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.
Stem Cell Educator
EXPERIMENTALused for the isolation and purification of cord blood stem cells.
Interventions
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 Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- Chinese governmentcollaborator
- Jinan Tianhe Stem Cell Biotechnologies Co Ltdcollaborator
Study Sites (1)
General Hospital of Jinan Military Command
Jinan, Shandong, 250031, China
Related Publications (4)
Zhao Y, Mazzone T. Human cord blood stem cells and the journey to a cure for type 1 diabetes. Autoimmun Rev. 2010 Dec;10(2):103-7. doi: 10.1016/j.autrev.2010.08.011. Epub 2010 Aug 20.
PMID: 20728583BACKGROUNDZhao Y, Lin B, Dingeldein M, Guo C, Hwang D, Holterman MJ. New type of human blood stem cell: a double-edged sword for the treatment of type 1 diabetes. Transl Res. 2010 May;155(5):211-6. doi: 10.1016/j.trsl.2010.01.003. Epub 2010 Feb 12.
PMID: 20403575BACKGROUNDZhao Y, Lin B, Darflinger R, Zhang Y, Holterman MJ, Skidgel RA. Human cord blood stem cell-modulated regulatory T lymphocytes reverse the autoimmune-caused type 1 diabetes in nonobese diabetic (NOD) mice. PLoS One. 2009;4(1):e4226. doi: 10.1371/journal.pone.0004226. Epub 2009 Jan 19.
PMID: 19156219BACKGROUNDZhao Y, Jiang Z, Zhao T, Ye M, Hu C, Zhou H, Yin Z, Chen Y, Zhang Y, Wang S, Shen J, Thaker H, Jain S, Li Y, Diao Y, Chen Y, Sun X, Fisk MB, Li H. Targeting insulin resistance in type 2 diabetes via immune modulation of cord blood-derived multipotent stem cells (CB-SCs) in stem cell educator therapy: phase I/II clinical trial. BMC Med. 2013 Jul 9;11:160. doi: 10.1186/1741-7015-11-160.
PMID: 23837842DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Zhao, MD, PhD
Universtiy of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 12, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 17, 2012
Record last verified: 2011-07