Stem Cell Educator Therapy in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01350219
• Other study ID #: 2010-037
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: September 2019

Study information

• Verified date: February 2019
• Source: Tianhe Stem Cell Biotechnologies Inc.
• Contact: Yong Zhao, MD, PhD
• Phone: 630 723 1968
• Email: yzhaowhl[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 60 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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 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 8 ~ 9 hrs.

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	General Hospital of Jinan Military Command	Jinan	Shandong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (2)

Lead Sponsor	Collaborator
Tianhe Stem Cell Biotechnologies Inc.	Chinese government fundings

Countries where clinical trial is conducted

China,  Spain, 

References & Publications (4)

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 ß cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3. — View Citation

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, 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

Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoimmune control	Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.	30 days post treatment
Secondary	Metabolic control	Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;	3 months
Secondary	Analysis of islet beta cell function	Test for C-peptide levels on the 6th month; Full evaluation of islet beta cell function after one year.	6 months

External Links

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