4.3 Article

Regulatory T-Cell Therapy in Transplantation: Moving to the Clinic

Journal

Publisher

COLD SPRING HARBOR LAB PRESS, PUBLICATIONS DEPT
DOI: 10.1101/cshperspect.a015552

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Funding

  1. Nicholas family
  2. UCSF Department of Surgery
  3. Roche Organ Transplantation Research Foundation
  4. Immune Tolerance Network [N01 AI15416]
  5. Juvenile Diabetes Research Foundation [4-2011-248]
  6. European Commission [260687]
  7. National Institutes of Health [U19 AI056388]

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Regulatory T cells (Tregs) are essential to transplantation tolerance and their therapeutic efficacy is well documented in animal models. Moreover, human Tregs can be identified, isolated, and expanded in short-term ex vivo cultures so that a therapeutic product can be manufactured at relevant doses. Treg therapy is being planned at multiple transplant centers around the world. In this article, we review topics critical to effective implementation of Treg therapy in transplantation. We will address issues such as Treg dose, antigen specificity, and adjunct therapies required for transplant tolerance induction. We will summarize technical advances in Treg manufacturing and provide guidelines for identity and purity assurance of Treg products. Clinical trial designs and Treg manufacturing plans that incorporate the most up-to-date scientific understanding in Treg biology will be essential for harnessing the tolerogenic potential of Treg therapy in transplantation.

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