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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

Enrique Gómez-Barrena 1, * Norma G. Padilla-Eguiluz 1 Cristina Avendaño-Solá 2 Concepción Payares-Herrera 2 Ana Velasco-Iglesias 2 Ferran Torres 3 Philippe Rosset 4 Florian Gebhard 5 Nicola Baldini 6 Juan C. Rubio-Suarez 1 Eduardo García-Rey 1 José Cordero-Ampuero 7 Javier Vaquero-Martin 8 Francisco Chana 8 Fernando Marco 9 Javier García-Coiradas 9 Pedro Caba-Dessoux 10 Pablo de La Cuadra 2 Philippe Hernigou 11 Charles-Henri Flouzat-Lachaniette 11 François Gouin 12 Didier Mainard 13, 14 Jean-Michel Laffosse 15, 16 Miriam Kalbitz 5 Ingo Marzi 17 Norbert Südkamp 18 Ulrich Stöckle 19 Gabriela Ciapetti 20 Davide Maria Donati 20 Luigi Zagra 21 Ugo Pazzaglia 22 Guido Zarattini 22 Rodolfo Capanna 23 Fabio Catani 24 
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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Enrique Gómez-Barrena, Norma G. Padilla-Eguiluz, Cristina Avendaño-Solá, Concepción Payares-Herrera, Ana Velasco-Iglesias, 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, Hindawi Publishing Corporation, 2018, 2018, pp.6025918. ⟨10.1155/2018/6025918⟩. ⟨hal-02110272⟩

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