Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial

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dc.contributor.author Gómez-Barrena, Enrique
dc.contributor.author Rosset, Philippe
dc.contributor.author Gebhard, Florian
dc.contributor.author Hernigou, Philippe
dc.contributor.author Baldini, Nicola
dc.contributor.author Rouard, Hèlene
dc.contributor.author Sensebé, Luc
dc.contributor.author Gonzalo-Daganzo, Rosa M.
dc.contributor.author Giordano, Rosaria
dc.contributor.author Padilla-Eguiluz, Norma
dc.contributor.author García-Rey, Eduardo
dc.contributor.author Cordero Ampuero, José
dc.contributor.author Rubio-Suárez, Juan Carlos
dc.contributor.author Stanovici, Julien
dc.contributor.author Ehrnthaller, Christian
dc.contributor.author Huber-Lang, Markus
dc.contributor.author Flouzat-Lachaniette, Charles Henri
dc.contributor.author Chevallier, Nathalie
dc.contributor.author Donati, Davide Maria
dc.contributor.author Ciapetti, Gabriela
dc.contributor.author Fleury, Sandrine
dc.contributor.author Fernández, Manuel-Nicolás
dc.contributor.author Cabrera, José-Rafael
dc.contributor.author Avendaño, Cristina
dc.contributor.author Montemurro, Tiziana
dc.contributor.author Panaitescu, Carmen
dc.contributor.author Veronesi, Elena
dc.contributor.author Rojewski, Markus Thomas
dc.contributor.author Lotfi, Ramin
dc.contributor.author Dominici, Massimo
dc.contributor.author Schrezenmeier, Hubert
dc.contributor.author Layrolle, Pierre
dc.contributor.other UAM. Departamento de Cirugía es_ES
dc.contributor.other UAM. Departamento de Farmacología es_ES
dc.contributor.other UAM. Departamento de Medicina es_ES
dc.contributor.other Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ) es_ES
dc.date.accessioned 2018-06-22T16:44:33Z
dc.date.available 2018-06-22T16:44:33Z
dc.date.issued 2018
dc.identifier.citation Biomaterials xx (2018): 1-9 en_US
dc.identifier.issn 0142-9612 (print) es_ES
dc.identifier.issn 1878-5905 (online) es_ES
dc.identifier.uri http://hdl.handle.net/10486/683265
dc.description.abstract Background: ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. Methods: Twenty-eight patients with femur, tibia or humerus diaphyseal or metaphyso-diaphyseal non-unions were recruited and surgically treated in France, Germany, Italy and Spain with 100 or 200 million BM-hMSC/mL associated with 5–10 cc of bioceramic granules. Patients were followed up during one year. The investigational advanced therapy medicinal product (ATMP) was expanded under the same protocol in all four countries, and approved by each National Competent Authority. Findings: With safety as primary end-point, no severe adverse event was reported as related to the BM-hMSC. With feasibility as secondary end-point, the participating production centres manufactured the BM-hMSC as planned. The ATMP combined to the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). Interpretation: Safety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic. Funding: EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876). en_US
dc.description.sponsorship The research leading to these results has received funding from the European Research Council under the European Union's Seventh Framework Programme (FP7/FP7-HEALTH-2009); REBORNE Project (GA: 241876) en_US
dc.format.extent 9 pag. es_ES
dc.format.mimetype application/pdf en
dc.language.iso eng en
dc.publisher Elsevier Ltd. en_US
dc.relation.ispartof Biomaterials en_US
dc.rights © 2018 The Authors en_US
dc.subject.other Clinical trial en_US
dc.subject.other Bioceramic en_US
dc.subject.other ATMP en_US
dc.subject.other Expanded autologous BM-hMSC en_US
dc.subject.other Non-union en_US
dc.subject.other Bone tissue engineering en_US
dc.title Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial en_US
dc.type article en
dc.subject.eciencia Medicina es_ES
dc.relation.publisherversion https://doi.org/10.1016/j.biomaterials.2018.03.033 es_ES
dc.identifier.doi 10.1016/j.biomaterials.2018.03.033 es_ES
dc.identifier.publicationfirstpage 1 es_ES
dc.identifier.publicationissue xxx es_ES
dc.identifier.publicationlastpage 9 es_ES
dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/241876 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion en
dc.rights.cc Reconocimiento – NoComercial – SinObraDerivada es_ES
dc.rights.accessRights openAccess en
dc.authorUAM Avendaño Sola, Cristina (259513)
dc.authorUAM Cabrera Marín, José R. (260103)
dc.authorUAM Cordero Ampuero, José (258314)
dc.authorUAM Rouanne , Laurence (269169)


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