A GMP Protocol for the Manufacture of Tregs for Clinical Application

Methods Mol Biol. 2023:2559:205-227. doi: 10.1007/978-1-0716-2647-4_14.

Abstract

Infusion of regulatory T cells is a promising therapeutic strategy in organ transplantation to modulate the immune system, prevent rejection, minimize the need for pharmaceutical immunosuppression, and improve long-term transplant outcomes. Here we describe a GMP-compliant method we have used for the manufacture of ex vivo expanded autologous regulatory T cells for use in clinical trials.

Keywords: Immunosuppression minimization; Regulatory T cells; Tolerance; Transplantation; Treg.

MeSH terms

  • Graft Rejection / prevention & control
  • Immune Tolerance
  • Immunosuppression Therapy
  • Organ Transplantation*
  • Pharmaceutical Preparations
  • T-Lymphocytes, Regulatory*

Substances

  • Pharmaceutical Preparations