Individualised immunosuppression with intravenously administered donor-derived modified immune cells compared with standard of care in living donor kidney transplantation (TOL-2 Study): protocol for a multicentre, open-label, phase II, randomised controlled trial

Introduction Donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation. In a phase I clinical trial (TOL-1 Study), MIC treatment resulted in a cellular phenotype that was directly and indirectly suppre...

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Main Authors: Lei Wang, Arianeb Mehrabi, Maria-Luisa Schubert, Anita Schmitt, Brigitte Neuber, Alexander Kunz, Angela Hückelhoven-Krauss, Carsten Müller-Tidow, Michael Schmitt, Christian Morath, Martin Zeier, Constantin Schwab, Anja Sander, Sabine Scherer, Claudius Speer, Christian Kleist, Claudia Sommerer, Florian Kälble, Christian Nusshag, Matthias Schaier, Louise Benning, Vedat Schwenger, Caner Süsal, Gerhard Opelz, T. Hien Tran, Stephan Kemmner, Michael Fischereder, Manfred Stangl, Ingeborg A. Hauser, Christian Bischofs, Sandra Sauer, Rüdiger Waldherr, Christopher Büsch, David Czock, Georg A Böhmig, Jochen Reiser, Axel Roers, Peter Terness, Volker Daniel
Format: Article
Language:English
Published: BMJ Publishing Group 2022-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/11/e066128.full