TY - JOUR
T1 - 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
T2 - Study protocol
AU - Gmez-Barrena, Enrique
AU - Padilla-Eguiluz, Norma G.
AU - Avendao-Sol, Cristina
AU - Payares-Herrera, Concepcin
AU - Velasco-Iglesias, Ana
AU - Torres, Ferran
AU - Rosset, Philippe
AU - Gebhard, Florian
AU - Baldini, Nicola
AU - Rubio-Suarez, Juan C.
AU - Garca-Rey, Eduardo
AU - Cordero-Ampuero, Jos
AU - Vaquero-Martin, Javier
AU - Chana, Francisco
AU - Marco, Fernando
AU - Garca-Coiradas, Javier
AU - Caba-Dessoux, Pedro
AU - De La Cuadra, Pablo
AU - Hernigou, Philippe
AU - Flouzat-Lachaniette, Charles Henri
AU - Gouin, Franois
AU - Mainard, Didier
AU - Laffosse, Jean Michel
AU - Kalbitz, Miriam
AU - Marzi, Ingo
AU - Sdkamp, Norbert
AU - Stckle, Ulrich
AU - Ciapetti, Gabriela
AU - Donati, Davide Maria
AU - Zagra, Luigi
AU - Pazzaglia, Ugo
AU - Zarattini, Guido
AU - Capanna, Rodolfo
AU - Catani, Fabio
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85049099716&partnerID=8YFLogxK
U2 - 10.1155/2018/6025918
DO - 10.1155/2018/6025918
M3 - Artículo
AN - SCOPUS:85049099716
SN - 1687-9678
VL - 2018
JO - Stem Cells International
JF - Stem Cells International
M1 - 6025918
ER -
