Stem Cell Educator Therapy in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415726
• Other study ID #: 2011-010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 10, 2011
• Last updated: February 16, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2011
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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 ß 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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
China	General Hospital of Jinan Military Command	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Chinese government, Jinan Tianhe Stem Cell Biotechnologies Co Ltd

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation control	Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers.	30 days post treatment	No
Secondary	Metabolic control	Before treatment, test for HbA1C levels as baseline; After treatment, test HbA1C levels on the 3rd month	3 months	No