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Related Experiment Video

Updated: Mar 29, 2026

High-Efficiency Generation of Antigen-Specific Primary Mouse Cytotoxic T Cells for Functional Testing in an Autoimmune Diabetes Model
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Type 1 diabetes immunotherapy using polyclonal regulatory T cells.

Jeffrey A Bluestone1, Jane H Buckner2, Mark Fitch3

  • 1Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA. jeff.bluestone@ucsf.edu.

Science Translational Medicine
|November 27, 2015
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Summary

Adoptive immunotherapy using expanded regulatory T cells (Tregs) shows promise for Type 1 diabetes (T1D). This phase 1 trial found the treatment safe, with Tregs persisting long-term and preserving insulin production in patients.

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Area of Science:

  • Immunology
  • Endocrinology
  • Cell Therapy

Background:

  • Type 1 diabetes (T1D) is an autoimmune disease linked to regulatory T cell (Treg) dysfunction.
  • Restoring Treg function may reverse T1D autoimmunity and protect pancreatic beta cells.

Purpose of the Study:

  • To assess the safety and feasibility of adoptive Treg immunotherapy in adult patients with T1D.
  • To evaluate the persistence and phenotype of adoptively transferred Tregs.

Main Methods:

  • Ex vivo expansion of autologous Tregs from T1D patients.
  • Administration of expanded Tregs in a phase 1 dose-escalation safety trial.
  • Monitoring of Treg persistence, phenotype, and clinical markers (e.g., C-peptide).

Main Results:

  • Adoptive Treg transfer was safe, with no high-grade adverse events or infusion reactions.
  • Transferred Tregs demonstrated long-term persistence (up to 25% at 1 year) and maintained their characteristic phenotype.
  • Transient increases in circulating Tregs were observed, and C-peptide levels remained stable in several participants for over two years.

Conclusions:

  • Ex vivo-expanded Treg adoptive immunotherapy is safe and well-tolerated in T1D patients.
  • The therapy supports Treg persistence and function, offering potential for disease modification.
  • Results warrant further investigation in a phase 2 efficacy trial.