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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 : January 4, 2018
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Tianhe Stem Cell Biotechnologies Inc.

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.

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.
Primary Purpose: Treatment
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 : May 30, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Yu Cheng, MD, PhD 86 10 55499301 chengyu_301@163.com

Locations
China
Department of Endocrinology, Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Yu Cheng, MD,PhD    86 10 55499301    chengyu_301@163.com   
Contact: Yiming Mu, MD,PhD    86 10 55499301    muyiming@301hospital.com.cn   
Sponsors and Collaborators
Tianhe Stem Cell Biotechnologies Inc.
Chinese PLA General Hospital
Investigators
Study Chair: Yong Zhao, MD,PhD Hackensack University Medical Center
Principal Investigator: Yiming Mu, MD,PhD Chinese PLA General Hospital

Additional Information:
Publications of Results:

Responsible Party: Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT03390231     History of Changes
Other Study ID Numbers: S2017-059-01
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Tianhe Stem Cell Biotechnologies Inc.:
Stem Cell Educator
Immune modulation
Diabetes
Autoimmune
Insulin resistance
Pancreatic islets

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases