Hurdles in therapy with regulatory T cells.
Improper activation of the immune system contributes to a variety of clinical conditions, including autoimmune and allergic diseases as well as solid organ and bone marrow transplantation. One approach to counteract this activation is through adoptive therapy with regulatory T cells (Tregs). Efforts to manufacture these cells have led to good maunfacturing practice-compliant protocols, and Treg products are entering early clinical trials. Here, we report the stance of the European Union Cooperation in Science and Technology Action BM1305, "Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies-A FACTT," which identifies hurdles hindering Treg clinical applications in Europe and provides possible solutions.
Medical University of Gdansk, Department of Clinical Immunology and Transplantology, Debinki 7, 80-952 Gdansk, Poland. All authors equally contributed to this work. ptrzon@gumed.edu.pl.
Piotr
P
Trzonkowski
Department of Pediatric Stem Cell Transplantation and Regenerative Medicine, Stanford School of Medicine, Standford, California, USA.
Rosa
R
Bacchetta
Diabetes Research Institute (DRI), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy.
Manuela
M
Battaglia
Uppsala University, Department of Immunology, Genetics and Pathology; Section of Clinical Immunology, Rudbeck Laboratory, 751 85 Uppsala, Sweden.
David
D
Berglund
Miltenyi Biotec GmbH, Clinical Business, Friedrich-Ebert-Straße 68, 51429 Bergisch Gladbach, Germany.
Hermann Richard
HR
Bohnenkamp
Department of Immunopathology, Sanquin Blood Supply, Division Research, Plesmanlaan 125, 1066 CX Amsterdam, Netherland and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Anja
A
ten Brinke
Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK.
Andrew
A
Bushell
Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp University Hospital (UZA), Wilrijkstraat 10, B-2650 Edegem, Belgium.
Nathalie
N
Cools
Division of Experimental Surgery, Department of Surgery, University Hospital Regensburg, Regensburg, Bavaria, 93053, Germany.
Edward K
EK
Geissler
San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET), Division of Regenerative Medicine, Stem Cells and Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Silvia
S
Gregori
Department of Immunopathology, Sanquin Blood Supply, Division Research, Plesmanlaan 125, 1066 CX Amsterdam, Netherland and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
S
S
Marieke van Ham
Institute of Cellular Medicine, Newcastle University NE2 4HH, UK.
Catharien
C
Hilkens
Division of Experimental Surgery, Department of Surgery, University Hospital Regensburg, Regensburg, 93053, Bavaria, Germany.
James A
JA
Hutchinson
Medical Research Council (MRC) Centre in Transplantation, Kings College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Giovanna
G
Lombardi
Anthony Nolan Research Institute, University College London (UCL) Royal Free Hospital Campus, 77c Fleet Road, London NW3 2QG, UK.
J Alejandro
JA
Madrigal
Department of Family Medicine, Medical University of Gdańsk, Ul. Dębinki 2 80-210 Gdańsk, Poland.
Natalia
N
Marek-Trzonkowska
Immunology Division, Germans Trias i Pujol University Hospital. Campus Can Ruti. Department of Cellular Biology, Physiology, and Immunology, Universitat Autònoma Barcelona 08916, Badalona, Barcelona, Spain.
Eva M
EM
Martinez-Caceres
San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET), Division of Regenerative Medicine, Stem Cells and Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy. Department of Pediatric Stem Cell Transplantation and Regenerative Medicine, Stanford School of Medicine, Stanford, California, USA.
Maria Grazia
MG
Roncarolo
Departamento de Inmunología Clínica, Hospital Clínico San Carlos, Calle Profesor Martín Lagos S/N, E- 28040 Madrid, Spain.
Silvia
S
Sanchez-Ramon
Anthony Nolan Research Institute, University College London (UCL) Royal Free Hospital Campus, 77c Fleet Road, London NW3 2QG, UK.
Aurore
A
Saudemont
AG Transplantationstoleranz, Charite Universitätsmedizin, Institut für Med. Imunologie, Augustenburgerplatz 1, 13353 Berlin, Germany.
Birgit
B
Sawitzki
D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D007167:Immunotherapy / Q000191:economics; D050378:T-Lymphocytes, Regulatory / Q000276:immunology*; D016896:Treatment Outcome