Stem Cell Educator Therapy in Diabetes

Last updated: February 2, 2019
Sponsor: Tianhe Stem Cell Biotechnologies Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03390231
S2017-059-01
  • Ages 20-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Exclusion criteria are any clinically significant diseases in liver, kidney, andheart. Additional exclusion criteria are no pregnancy, no immunosuppressivemedication, no viral diseases or diseases associated with immunodeficiency.

Study Design

Total Participants: 100
Study Start date:
November 27, 2017
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Department of Endocrinology, Chinese PLA General Hospital

    Beijing, 100853
    China

    Active - Recruiting

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