Stem Cell Educator Therapy in Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Molecular Mechanisms Underlying Stem Cell Educator Therapy for the Treatment of Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03390231
• Other study ID #: S2017-059-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 27, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Tianhe Stem Cell Biotechnologies Inc.
• Contact: Yu Cheng, MD, PhD
• Phone: 86 10 55499301
• Email: chengyu_301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stem Cell Educator (SCE) therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SCs) in vitro, and returns only the "educated" autologous immune cells to the patient's circulation. Several mechanistic studies with clinical samples and animal models have demonstrated the proof of concept and clinical safety of SCE therapy. They suggest SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages when these are exposed to the autoimmune regulator protein (AIRE) in the CB-SCs. In this project, the optimized SCE therapy for type 1 diabetes (T1D) and T2D will be tested in a prospective, single-arm, open-label, single-center study to assess its clinical efficacy and related molecular mechanisms in patients with diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.

Exclusion Criteria:

• Exclusion criteria are any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Combination Product:
• Stem Cell Educator therapy
It briefly cocultures the patient's lymphocytes with CB-SCs in vitro, induces immune tolerance through the action of autoimmune regulator (AIRE, expressed by CB-SCs), returns the educated autologous lymphocytes to the patient's circulation, and restores immune balance and homeostasis.

Locations

Country	Name	City	State
China	Department of Endocrinology, Chinese PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Tianhe Stem Cell Biotechnologies Inc.	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educa — View Citation

Zhao Y, Jiang Z, Delgado E, Li H, Zhou H, Hu W, Perez-Basterrechea M, Janostakova A, Tan Q, Wang J, Mao M, Yin Z, Zhang Y, Li Y, Li Q, Zhou J, Li Y, Martinez Revuelta E, Maria García-Gala J, Wang H, Perez-Lopez S, Alvarez-Viejo M, Menendez E, Moss T, Guin — View Citation

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 mu — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of inflammation-related markers in diabetic patients after Stem Cell Educator therapy	After treatment for 30 days, diabetic patients will be tested for inflammation-related markers (e.g.,Th1/Th2 cytokines) by flow cytometry and compare with the baseline levels.	30 days
Secondary	Change in insulin resistance	Before treatment, test for insulin sensitivity by chip analysis as baseline; After treatment, test sensitivity levels on the 1st month.	30 days
Secondary	Metabolic control in HbA1C levels	Before treatment, test for HbA1C levels as baseline; After treatment, repeat these testing on the 3rd month. Hemoglobin A1c (HbA1c) will be reported as the changes in percentage.	3 months
Secondary	Metabolic control in blood glucose levels	Before treatment, test for fasting glucose as baseline; After treatment, repeat these testing on the 3rd month. The blood glucose level will be measured as mMol/L.	3 months
Secondary	Metabolic control in fasting C-peptide levels	Before treatment, test for C-peptide levels as baseline; After treatment, repeat these testing on the 3rd month. C-peptide will be measure as ng/mL.	3 months

External Links

•   Chinese PLA Hospital
•   Tianhe Stem Cell Biotechnologies