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Stem Cells Int. 2018 Feb 22;2018:6025918. doi: 10.1155/2018/6025918. eCollection 2018.

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.

Author information

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

Abstract

ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments). The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 106 hBM-MSCs is noninferior to that of 200 × 106 hBM-MSCs. The participants (n = 108) will be randomly assigned to either the experimental low dose (n = 36), the experimental high dose (n = 36), or the comparator arm (n = 36) using a central randomization service. The trial will be conducted in 20 clinical centres in Spain, France, Germany, and Italy under the same clinical protocol. The confirmation of superiority for the proposed ATMP in nonunions may foster the future of bone regenerative medicine in this indication. On the contrary, absence of superiority may underline its limitations in clinical use.

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