Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Stem Cell Educator, Immune modulation, Diabetes, Autoimmune, Insulin resistance, Pancreatic islets
Brief 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.
Interventions
COMBINATION_PRODUCTStem 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.
Sponsors
Chinese PLA General Hospital
Throne Biotechnologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study with all subjects received SCE therapy.
Intervention model description
In this project, the optimized SCE therapy for diabetes will be tested in a prospective, single-arm, open-label, single-center study
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of inflammation-related markers in diabetic patients after Stem Cell Educator therapy | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance | 30 days | Before treatment, test for insulin sensitivity by chip analysis as baseline; After treatment, test sensitivity levels on the 1st month. |
| Metabolic control in HbA1C levels | 3 months | 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. |
| Metabolic control in blood glucose levels | 3 months | 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. |
| Metabolic control in fasting C-peptide levels | 3 months | 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. |
Countries
China
Contacts
Primary ContactYu Cheng, MD, PhD
Outcome results
None listed