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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

Gómez-Barrena, Enrique and Padilla-Eguiluz, Norma G. and Avendaño-Solá, Cristina and Payares-Herrera, Concepción and Velasco-Iglesias, Ana and Torres, Ferran and Rosset, Philippe and Gebhard, Florian and Baldini, Nicola and Rubio-Suarez, Juan C. and García-Rey, Eduardo and Cordero-Ampuero, José and Vaquero-Martin, Javier and Chana, Francisco and Marco, Fernando and García-Coiradas, Javier and Caba-Dessoux, Pedro and De la Cuadra, Pablo and Hernigou, Philippe and Flouzat-Lachaniette, Charles-Henri and Gouin, François and Mainard, Didier and Laffosse, Jean-Michel and Kalbitz, Miriam and Marzi, Ingo and Südkamp, Norbert and Stöckle, Ulrich and Ciapetti, Gabriela and Donati, Davide Maria and Zagra, Luigi and Pazzaglia, Ugo and Zarattini, Guido and Capanna, Rodolfo and Catani, Fabio 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. (2018) Stem Cells International, 2018. 1-13. ISSN 1687-966X

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Official URL: https://doi.org/10.1155/2018/6025918

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.

Item Type:Article
HAL Id:hal-02110272
Audience (journal):International peer-reviewed journal
Uncontrolled Keywords:
Institution:Other partners > Centre Hospitalier Universitaire de Toulouse - CHU Toulouse (FRANCE)
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Deposited By: Pascal SWIDER
Deposited On:25 Apr 2019 10:14

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