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 Gmez-Barrena, Norma G. Padilla-Eguiluz, Cristina Avendao-Sol, Concepcin Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C. Rubio-Suarez, Eduardo Garca-Rey, Jos Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier Garca-Coiradas, Pedro Caba-Dessoux, Pablo De La Cuadra, Philippe Hernigou, Charles Henri Flouzat-LachanietteFranois Gouin, Didier Mainard, Jean Michel Laffosse, Miriam Kalbitz, Ingo Marzi, Norbert Sdkamp, Ulrich Stckle, Gabriela Ciapetti, Davide Maria Donati, Luigi Zagra, Ugo Pazzaglia, Guido Zarattini, Rodolfo Capanna, Fabio Catani

Research output: Contribution to journalArticle

Abstract

© 2018 Enrique Gmez-Barrena et al. 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.
Original languageEnglish
JournalStem Cells International
Volume2018
DOIs
Publication statusPublished - Jan 1 2018

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    Gmez-Barrena, E., Padilla-Eguiluz, N. G., Avendao-Sol, C., Payares-Herrera, C., Velasco-Iglesias, A., Torres, F., Rosset, P., Gebhard, F., Baldini, N., Rubio-Suarez, J. C., Garca-Rey, E., Cordero-Ampuero, J., Vaquero-Martin, J., Chana, F., Marco, F., Garca-Coiradas, J., Caba-Dessoux, P., De La Cuadra, P., Hernigou, P., ... Catani, F. (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. Stem Cells International, 2018. https://doi.org/10.1155/2018/6025918