ClinicalTrials.gov
ClinicalTrials.gov Menu

Stem Cell Educator Therapy in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03390231
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Tianhe Stem Cell Biotechnologies Inc.

November 14, 2017
January 4, 2018
January 4, 2018
November 27, 2017
May 30, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Stem Cell Educator Therapy in Diabetes
Molecular Mechanisms Underlying Stem Cell Educator Therapy for the Treatment of Diabetes
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.
Not Provided
Interventional
Phase 2
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.
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
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.
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.
Intervention: Combination Product: Stem Cell Educator therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
December 31, 2020
May 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
No
Contact: Yu Cheng, MD, PhD 86 10 55499301 chengyu_301@163.com
China
 
 
NCT03390231
S2017-059-01
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: Undecided
Tianhe Stem Cell Biotechnologies Inc.
Tianhe Stem Cell Biotechnologies Inc.
Chinese PLA General Hospital
Study Chair: Yong Zhao, MD,PhD Hackensack Meridian Health
Principal Investigator: Yiming Mu, MD,PhD Chinese PLA General Hospital
Tianhe Stem Cell Biotechnologies Inc.
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP