Safety and tolerability of a single infusion of autologous ex vivo expanded regulatory T cells in adults with ulcerative colitis (ER-TREG 01): protocol of a phase 1, open-label, fast-track dose-escalation clinical trial

Safety and tolerability of a single infusion of autologous ex vivo expanded regulatory T cells in adults with ulcerative colitis (ER-TREG 01): protocol of a phase 1, open-label, fast-track dose-escalation clinical trial

Introduction Accumulating evidence suggests that the adoptive transfer of ex vivo expanded regulatory T cells (Treg) may overcome colitogenic immune responses in patients with inflammatory bowel diseases. The objective of the ER-TREG 01 trial is to assess safety and tolerability of a single infusion...

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Main Authors: Carola Berking, Raja Atreya, Markus F Neurath, Sebastian Zundler, Britta Siegmund, Gerold Schuler, Francesco Vitali, Caroline J Voskens, Diane Stoica, Susanne Roessner, Marita Rosenberg, Manuel Wiesinger, Jutta Wunder, Beatrice Schuler-Thurner
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e049208.full
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