title: Regulatory T-cell therapy in transplantation: moving to the clinic.
abstract: 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.
authors.affiliation: Department of Surgery, University of California, San Francisco, San Francisco, California 94143.
authors.forename: Qizhi
authors.initials: Q
authors.lastname: Tang
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Bluestone
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D064591:Allografts; D000818:Animals; D002469:Cell Separation / Q000379:methods; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007519:Isoantigens / Q000502:physiology; D051379:Mice; D050378:T-Lymphocytes, Regulatory / Q000637:transplantation*; D014180:Transplantation / Q000379:methods*; D023001:Transplantation Tolerance / Q000502:physiology*
chemical_list: D000276:Adjuvants, Immunologic; D007166:Immunosuppressive Agents; D007519:Isoantigens