Stem Cell Educator Therapy in Diabetes
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|ClinicalTrials.gov Identifier: NCT03390231|
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2||Combination Product: Stem Cell Educator therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Masking:||None (Open Label)|
|Masking Description:||Open-label study with all subjects received SCE therapy.|
|Official Title:||Molecular Mechanisms Underlying Stem Cell Educator Therapy for the Treatment of Diabetes|
|Actual Study Start Date :||November 27, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Stem Cell Educator
The Stem Cell Educator (SCE) technology involves a closed-loop system that circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent CB-SCs in vitro, and returns only the "educated" immune cells to the patient's circulation. Several mechanistic studies with clinical samples and animal models have been conducted to demonstrate the proof of concept and clinical safety of SCE therapy. They suggest that SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages that are encountered through the action of the autoimmune regulator (AIRE) and other molecular mechanisms. Following induction of immune tolerance in the immune cells, the immune balance and homeostasis may be restored when treated cells are returned in vivo.
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.
- Changes of inflammation-related markers in diabetic patients after Stem Cell Educator therapy [ Time Frame: 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.
- Change in insulin resistance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390231
|Contact: Yu Cheng, MD, PhD||86 10 firstname.lastname@example.org|
|Department of Endocrinology, Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Yu Cheng, MD,PhD 86 10 55499301 email@example.com|
|Contact: Yiming Mu, MD,PhD 86 10 55499301 firstname.lastname@example.org|
|Study Chair:||Yong Zhao, MD,PhD||Hackensack Meridian Health|
|Principal Investigator:||Yiming Mu, MD,PhD||Chinese PLA General Hospital|