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

Voskens C, Stoica D, Roessner S, Vitali F, Zundler S, Rosenberg M, Wiesinger M, Wunder J, Siegmund B, Schuler-Thurner B, Schuler G, Berking C, Atreya R, Neurath M (2021)

Publication Type: Journal article

Publication year: 2021

Journal

BMJ Open BMJ Publishing Group

Book Volume: 11

Journal Issue: 12

DOI: 10.1136/bmjopen-2021-049208

Abstract

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 of autologous ex vivo expanded Treg in adults with ulcerative colitis.

Authors with CRIS profile

Caroline Bosch-Voskens Department of Dermatology Francesco Vitali Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Sebastian Zundler Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Beatrice Schuler-Thurner Lehrstuhl für Haut- und Geschlechtskrankheiten Gerold Schuler Lehrstuhl für Haut- und Geschlechtskrankheiten Carola Berking Lehrstuhl für Haut- und Geschlechtskrankheiten Raja Atreya Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen (Heisenberg-Professur) Markus Neurath Lehrstuhl für Innere Medizin I

Involved external institutions

Charité - Universitätsmedizin Berlin DE Germany (DE)

How to cite

APA:

Voskens, C., Stoica, D., Roessner, S., Vitali, F., Zundler, S., Rosenberg, M.,... Neurath, M. (2021). 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. BMJ Open, 11(12). https://doi.org/10.1136/bmjopen-2021-049208

MLA:

Voskens, Caroline, et al. "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." BMJ Open 11.12 (2021).

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