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| Name | Class |
|---|---|
| Chinese government | UNKNOWN |
| Jinan Tianhe Stem Cell Biotechnologies Co Ltd | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cord blood stem cell | Experimental | 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. |
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| Stem Cell Educator | Experimental | used for the isolation and purification of cord blood stem cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Educator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation control | Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers. | 30 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic control | Before treatment, test for HbA1C levels as baseline; After treatment, test HbA1C levels on the 3rd month | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Zhao, MD, PhD | Universtiy of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Jinan Military Command | Jinan | Shandong | 250031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20728583 | Background | 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. | |
| 20403575 | Background | Zhao 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 19156219 | Background | Zhao 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. |
| 23837842 | Derived | Zhao 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. |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |