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

• Published in: Stem cells international Vol. 2018; pp. 6025918 - 13
• Main Authors: Gómez-Barrena, Enrique, Padilla-Eguiluz, Norma G., Avendaño-Solá, Cristina, Payares-Herrera, Concepción, Velasco-Iglesias, Ana, Torres, Ferran, Rosset, Philippe, Gebhard, Florian, Baldini, Nicola, Rubio-Suarez, Juan C., García-Rey, Eduardo, Cordero-Ampuero, José, Vaquero-Martin, Javier, Chana, Francisco, Marco, Fernando, García-Coiradas, Javier, Caba-Dessoux, Pedro, de la Cuadra, Pablo, Hernigou, Philippe, Flouzat-Lachaniette, Charles-Henri, Gouin, François, Mainard, Didier, Laffosse, Jean Michel, Kalbitz, Miriam, Marzi, Ingo, Südkamp, Norbert, Stöckle, Ulrich, Ciapetti, Gabriela, Donati, Davide Maria, Zagra, Luigi, Pazzaglia, Ugo, Zarattini, Guido, Capanna, Rodolfo, Catani, Fabio
• Format: Journal Article
• Language: English
• Published: United States Hindawi 01.01.2018; John Wiley & Sons, Inc; Hindawi Limited; Hindawi Publishing Corporation; Wiley
• Subjects: Autografts; Biological products; Biomaterials; Bone healing; Bone marrow; Clinical trials; Comparative analysis; Feasibility studies; Femur; Fractures; Good Manufacturing Practice; Healing; Human health and pathology; Humerus; Iliac crest; Injuries; Joint surgery; Life Sciences; Long bone; Mesenchyme; Nonunion; Pain; Patients; Product development; Regenerative medicine; Santé publique et épidémiologie; Skin & tissue grafts; Stem cells; Surgery; Tibia; Traffic accidents & safety; Transplantation of organs, tissues, etc; Transplants & implants; France; Illiac crest; Bone fracture; Stem cells

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 enh...