Study concept and design: van Laar, Farge, Sont, Tyndall.
Acquisition, analysis, or interpretation of data: All authors
Drafting of the manuscript: van Laar, Farge, Tyndall.
Critical revision of the manuscript for important intellectual content: van Laar, Farge, Sont, Naraghi, Marjanovic, Larghero, Schuerwegh, Marijt, Vonk, Schattenberg, Matucci-Cerinic, Voskuyl, van de Loosdrecht, Daikeler, Kötter, Schmalzing, Martin, Lioure, Weiner, Kreuter, Deligny, Durand, Emery, Machold, Sarrot-Reynauld, Warnatz, Adoue, Constans, Tony, Del Papa, Fassas, Himsel, Launay, Lo Monaco, Philippe, Quéré, Rich, Westhovens, Griffiths, Saccardi, van den Hoogen, Fibbe, Socié, Gratwohl, Tyndall.
Statistical analysis: Sont, Naraghi.
Obtained funding: van Laar, Farge, Tyndall.
Study supervision: van Laar, Farge, Tyndall.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr van Laar reported receiving a research grant from Roche and honoraria from Genentech, Roche, Menarini, Bristol-Myers Squibb, Abbott, Novartis, Miltenyi, Tigenix, and Pfizer. Dr Vonk reported receiving research grants from Actelion and Therabel and serving as a consultant for Actelion, United therapeutics, and Pfizer. Dr Koetter reported receiving a grant from Novartis and personal fees from Abbvie, Roche, Pfizer, and UCB. Dr Emery reported receiving consulting and speakers fees from Abbvie, Bristol-Myers Squibb, Pfizer, UCB, Merck Sharp & Dohme, and Roche. Dr Warnatz reported receiving grants from Deutsche Forschungsgemeinschaft and Bundesministerium für Bildung und Forschung and speakers fees from Baxter, GlaxoSmithKline, CSL Behring, Pfizer, and the American Academy of Allergy, Asthma, and Immunology. Dr Adoue reported receiving honoraria from Amgen, GlaxoSmithKline, and Actelion. Dr Tony reported receiving speakers fees from and serving as a consultant for Abbvie, Bristol-Myers Squibb, Chugai, Merck Sharp & Dohme, Roche, and UCB. Dr Launay reported receiving honoraria from Actelion, GlaxoSmithKline, and Pfizer. Dr Westhovens reported receiving research grants from UCB and Roche; speakers fees from Bristol-Myers Squibb; and honoraria from Janssen and Galapagos. Dr Tyndall reported receiving grants from Imtex-Sangstat and Amgen. No other authors reported disclosures.
Funding/Support: The European Group for Blood and Marrow Transplantation (EBMT) and European League Against Rheumatism (EULAR) jointly supported the costs of the trial management and operations and approved submission of the manuscript. The Assistance Publique-Hôpitaux de Paris (AP-HP), French Ministry of Health Programme Hospitalier de Recherche Clinique (Ministère de la Santé–PHRC AOM 97030), Groupe Francophone de Recherche sur la Sclérodermie supported trial operations in French centres and approved submission of the manuscript. The Association des Sclérodermiques de France contributed to support of the trial in France. The National Institute for Health Research (NIHR) and NIHR Newcastle Biomedical Research Centre financially supported the Study Administration Office. Unrestricted grants were secured from Imtix-Sangstat and Amgen Europ; Miltenyi-Biotec supported the trial through provision of CD34-selection columns at a discount.
Role of the Sponsors: None of the commercial funders had any role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation of the manuscript; and decision to submit the manuscript for publication.
EBMT/EULAR Scleroderma Study Group Centers and Investigators: Medical University of Vienna, Vienna, Austria (Klaus P. Machold, MD, principal investigator; Hildegard Greinix, MD); Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU, Leuven; Rheumatology, University Hospitals, Leuven, Belgium (René Westhovens, MD, PhD, principal investigator); Service de Rhumatologie, Centre Hospitalier de l’Université de Montréal, Montréal, Quebec, Canada (Eric Rich, MD, principal investigator); CHU Bordeaux, Bordeaux, France (Joël Constans, MD, principal investigator; Noël Milpied, MD); CHU Clermont Ferrand, Clermont Ferrand, France (Pierre Philippe, MD, principal investigator; Olivier Tournilhac, MD); Hôpital Pierre Zobda Quitman, Fort-de-France, Martinique (Christophe Deligny, MD, principal investigator; Serge Arfi, MD); CHU Grenoble, Grenoble, France (Francoise Sarrot-Reynauld, MD, PhD, principal investigator, Christophe Senturier, MD, Frederic Garban, MD); CHRU Lille, Lille, France (David Launay, MD, PhD, principal investigator; Louis Terriou, MD); CHU La Conception, Marseille, France (Jean Marc Durand, MD, PhD, principal investigator; Didier Blaise, MD); CHU Montpellier, Montpellier, France (Isabelle Quéré, MD, PhD, principal investigator); AP-HP Hôpital Saint-Louis, Paris, France (Dominique Farge, MD, PhD, principal investigator; Zora Marjanovic, MD, Jérôme Larghero, PharMD, PhD, Eliane Gluckmann, MD, PhD, Gérard Socié, MD, PhD); CHRU Strasbourg, Strasbourg, France (Thierry Martin, MD, PhD, principal investigator; Bruno Lioure, MD, Jean Sibilia, MD); CHU Toulouse, Toulouse, France (Daniel F. P. Adoue, MD, principal investigator; Odile B. Beyne-Rrauzy, MD, PhD); University Clinic Frankfurt, Frankfurt, Germany (Andrea Himsel, MD, principal investigator; Axel Braner); University Hospital Freiburg, Freiburg, Germany (Klaus Warnatz, MD, principal investigator; Jürgen Finke, MD, Hans Hartmut Peter, MD); Ruhr-University Bochum, Bochum, Germany (Stefan M. Weiner, MD, principal investigator; Alexander Kreuter, MD, Roland Schroers, MD, Christian Teschendorf, MD); University Clinic Tübingen, Tübingen, Germany (Ina Kötter, MD, PhD, principal investigator; Marc Schmalzing, MD, Jörg Henes, MD); Department of Rheumatology and Clinical Immunology, University of Würzburg Medical Center, Würzburg, Germany (Hans-Peter Tony, MD, principal investigator; Stefan Kleinert, MD); George Papanicolaou Hospital, Thessaloniki, Greece (Athanasios Fassas, MD, principal investigator); University of Ferrara and Azienda, Ferrara, Italy (Andrea Lo Monaco, MD, PhD, principal investigator); University of Florence, Florence, Italy (Marco Matucci-Cerinic, MD, PhD, principal investigator; Irene Miniati, MD, Silvia Bellando-Randone, MD, Serena Guiducci, MD, Riccardo Saccardi, MD); University of Milan, Milan, Italy (Nicoletta Del Papa, MD, PhD, principal investigator); VU University Medical Center, Amsterdam, the Netherlands (Alexandre E. Voskuyl, MD, PhD, principal investigator; Arjan A. van de Loosdrecht, MD, PhD, Peter C. Huijgens, MD, PhD); Leiden University Medical Center, Leiden, the Netherlands (Annemie J. Schuerwegh, MD, PhD, principal investigator; Erik W. Marijt, MD, PhD, Willem E. Fibbe, MD, PhD, Jacob K. Sont, PhD); Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (Madelon C. Vonk, MD, PhD, principal investigator; Hanneke Knaapen, MD, Anton V. M. B. Schattenberg, MD, PhD, Frank H. van den Hoogen, MD, PhD); University Hospital Basel, Basel, Switzerland (Alan Tyndall, MD, principal investigator; Thomas Daikeler, MD, Paul Hasler, MD, Peter Villiger, MD, Michael Seitz, MD, Alois Gratwohl, MD); University of Leeds, Leeds, United Kingdom (Paul Emery, MD, principal investigator; Maya H. Buch, MD, Shouvik Dass, MD, Rachel Kilding, MD); The James Cook University Hospital, Middlesbrough, United Kingdom (Jacob M. van Laar, MD, PhD, principal investigator; Kamran Naraghi, MD); Freeman Hospital, Newcastle upon Tyne, United Kingdom (Bridget Griffiths, MD, principal investigator; Matthew Collin, MD, PhD, John McLaren, MD).
Previous Presentations: Presented in part at the 13th Annual Meeting of the European League Against Rheumatism; June 6-9, 2012; Berlin, Germany; the 2012 Annual Meeting of the American College of Rheumatology; November 10-14, 2012; Washington DC; and the 54th Annual Meeting of the American Society of Hematology, December 8-11, 2012; Atlanta, Georgia.
Additional Contributions: We thank Professor Ronald Brand, PhD (EBMT Office, Leiden, the Netherlands), for lending his expertise with the statistical analyses and owe gratitude to the participating patients and their families, as well as the research nurses, trial coordinators, and operations staff for their contributions; the investigators whose patients were enrolled in the ASTIS trial; and the members of the Independent Data Monitoring Committee (Jane Apperley, MD [Imperial College London, United Kingdom], Daniel Furst, MD [UCLA, Los Angeles, California], Frank Wollheim, MD [Lund University, Sweden]). We also acknowledge the following for administrative, technical, or material support: University Hospital Basel, Basel, Switzerland (Iris Gerber, MD; Chiara Tyndall, PhD); Leiden University Medical Center, Leiden, the Netherlands (Ingeborg de Jonge, Annemiek J.M.S. Versluys-van Duinhoven); Hôpital St Louis, Paris, France (Sylvie Parlier, Homah Keshmandt, Mébarka Bettar); The James Cook University Hospital, Middlesbrough, United Kingdom (Susan Hales); EBMT Clinical Trial Office, London, United Kingdom (Liz Clark, MSc, Ruzena Uddin, MSci, Janette Zarev, MSc, Kim Champion, PhD, Zoë Doran). None of the persons listed in the above sections not listed as authors received compensation.