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Stem Cells International
Volume 2018, Article ID 6025918, 13 pages
https://doi.org/10.1155/2018/6025918
Research Article

A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol

1Servicio de Cirugía Ortopédica y Traumatología, Hospital de Traumatología, Hospital La Paz, IdiPAZ, Universidad Autónoma de Madrid, P° Castellana 261, 28046 Madrid, Spain
2Hospital Universitario La Paz, HTR Planta 1, Despacho Médico, Universidad Autónoma de Madrid, P° Castellana 261, 28046 Madrid, Spain
3Clinical Pharmacology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain
4Clinical Pharmacology Unit, IIS Puerta de Hierro-Segovia de Arana, Hospital Universitario Puerta de Hierro Majadahonda, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain
5IIS Puerta de Hierro-Segovia de Arana, SCRen, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain
6Hospital Clínic de Barcelona, Biostatistics Unit, IDIBAPS, Carrer de Villarroel 170, 08036 Barcelona, Spain
7Chirurgie Orthopédique et Traumatologique, Centre Hospitalier et Universitaire de Tours, Avenue de la République, 37170 Chambray Les Tours, France
8Department of Orthopaedic Trauma, Ulm University Hospital, Albert-Einstein-Allee 23, 89081 Ulm, Germany
9Dipartimento di Scienze Biomediche e Neuromotorie, Alma Mater Studiorum-Università di Bologna, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy
10Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz, P° Castellana 26, 28046 Madrid, Spain
11Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Princesa, Calle Diego de León 62, 28006 Madrid, Spain
12Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Gregorio Marañón, Calle del Dr. Esquerdo 46, 28007 Madrid, Spain
13Servicio de Cirugía Ortopédica y Traumatología, Hospital Clínico San Carlos, Calle del Prof. Martín Lagos, s/n, 28040 Madrid, Spain
14Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario 12 de Octubre, Avenida de Córdoba, s/n, 28041 Madrid, Spain
15Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Puerta de Hierro Majadahonda, Calle Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain
16Department of Orthopaedic Surgery, Hospital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil Cedex, France
17Department of Orthopaedic Surgery, CHU Nantes, 1 Place Alexis-Ricordeau, 44093 Nantes Cedex 1, France
18Department of Orthopaedic Surgery, CHU Nancy, 5 rue du Morvan, 54500 Vandœuvre-lès-Nancy, France
19Department of Orthopaedic Surgery, CHU Toulouse, 170 Avenue de Casselardit, 31059 Toulouse, France
20Department of Trauma, Hand and Reconstructive Surgery, Universitätsklinikum Frankfurt, Universitätsklinikum-Haus 1, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany
21Klinikfür Orthopädie und Unfallchirurgie, Universitätsklinikum Freiburg, Hugstetter Str. 55, 79106 Freiburg im Breisgau, Germany
22Klinikfür Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Tübingen, Schnarrenbergstraße 95, 72076 Tübingen, Germany
23SSD Fisiopatologia Ortopedica e Medicina Rigenerativa, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy
24Clinica Ortopedica e Traumatologica III a Prevalente Indirizzo Oncologico, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy
25Chirugia dell’Anca 1, Istituto Ortopedico Galeazzi, Via Riccardo Galeazzi 4, 20161 Milano, Italy
26Azienda Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy
27II Clinica Universitaria Ortopedia e Traumatologia, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56126 Pisa, Italy
28Reparto di Ortopedia e Traumatologia, Azienda Ospedaliero-Universitaria di Modena, Largo del Pozzo 71, 41125 Modena, Italy

Correspondence should be addressed to Enrique Gómez-Barrena; se.mau@anerrabzemog.euqirne

Received 23 June 2017; Revised 13 November 2017; Accepted 6 December 2017; Published 22 February 2018

Academic Editor: Heinrich Sauer

Copyright © 2018 Enrique Gómez-Barrena et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to Cite this Article

Enrique Gómez-Barrena, Norma G. Padilla-Eguiluz, Cristina Avendaño-Solá, et al., “A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol,” Stem Cells International, vol. 2018, Article ID 6025918, 13 pages, 2018. https://doi.org/10.1155/2018/6025918.