Polyclonal Regulatory T Cell Therapy for Control of Inflammation in Kidney Transplants

Am J Transplant. 2017 Nov;17(11):2945-2954. doi: 10.1111/ajt.14415. Epub 2017 Aug 14.


Early subclinical inflammation in kidney transplants is associated with later graft fibrosis and dysfunction. Regulatory T cells (Tregs) can reverse established inflammation in animal models. We conducted a pilot safety and feasibility trial of autologous Treg cell therapy in three kidney transplant recipients with subclinical inflammation noted on 6-month surveillance biopsies. Tregs were purified from peripheral blood and polyclonally expanded ex vivo using medium containing deuterated glucose to label the cells. All patients received a single infusion of ~320 × 106 (319, 321, and 363.8 × 106 ) expanded Tregs. Persistence of the infused Tregs was tracked. Graft inflammation was monitored with follow-up biopsies and urinary biomarkers. Nearly 1 × 109 (0.932, 0.956, 1.565 × 109 ) Tregs were successfully manufactured for each patient. There were no infusion reactions or serious therapy-related adverse events. The infused cells demonstrated patterns of persistence and stability similar to those observed in non-immunosuppressed subjects receiving the same dose of Tregs. Isolation and expansion of Tregs is feasible in kidney transplant patients on immunosuppression. Infusion of these cells was safe and well tolerated. Future trials will test the efficacy of polyclonal and donor alloantigen-reactive Tregs for the treatment of inflammation in kidney transplants.

Keywords: cellular biology; clinical trial; immune regulation; immunobiology; immunosuppressant - polyclonal preparations; kidney transplantation/nephrology; protocol biopsy; rejection: subclinical; translational research/science.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Follow-Up Studies
  • Glomerular Filtration Rate
  • Graft Rejection / etiology
  • Graft Rejection / pathology
  • Graft Rejection / therapy*
  • Graft Survival
  • Humans
  • Inflammation / etiology
  • Inflammation / pathology
  • Inflammation / therapy*
  • Isoantigens
  • Kidney Failure, Chronic / surgery*
  • Kidney Function Tests
  • Kidney Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Pilot Projects
  • Postoperative Complications
  • Prognosis
  • Risk Factors
  • T-Lymphocytes, Regulatory / immunology*
  • Tissue Donors
  • Young Adult


  • Isoantigens