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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

Author
Gómez-Barrena, Enrique; Rosset, Philippe; Gebhard, Florian; Hernigou, Philippe; Baldini, Nicola; Rouard, Hèlene; Sensebé, Luc; Gonzalo-Daganzo, Rosa M.; Giordano, Rosaria; Padilla-Eguiluz, Norma; García Rey, Eduardountranslated; Cordero Ampuero, Joséuntranslated; Rubio-Suárez, Juan Carlos; Stanovici, Julien; Ehrnthaller, Christian; Huber-Lang, Markus; Flouzat-Lachaniette, Charles Henri; Chevallier, Nathalie; Donati, Davide Maria; Ciapetti, Gabriela; Fleury, Sandrine; Fernández, Manuel-Nicolás; Cabrera, José-Rafael; Avendaño Solá, Cristinauntranslated; Montemurro, Tiziana; Panaitescu, Carmen; Veronesi, Elena; Rojewski, Markus Thomas; Lotfi, Ramin; Dominici, Massimo; Schrezenmeier, Hubert; Layrolle, Pierre
Entity
UAM. Departamento de Cirugía; UAM. Departamento de Farmacología; UAM. Departamento de Medicina; Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ)
Publisher
Elsevier Ltd.
Date
2018
Citation
10.1016/j.biomaterials.2018.03.033
Biomaterials xx (2018): 1-9
 
 
 
ISSN
0142-9612 (print); 1878-5905 (online)
DOI
10.1016/j.biomaterials.2018.03.033
Funded by
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)
Project
info:eu-repo/grantAgreement/EC/FP7/241876
Editor's Version
https://doi.org/10.1016/j.biomaterials.2018.03.033
Subjects
Clinical trial; Bioceramic; ATMP; Expanded autologous BM-hMSC; Non-union; Bone tissue engineering; Medicina
URI
http://hdl.handle.net/10486/683265
Rights
© 2018 The Authors

Licencia de Creative Commons
Esta obra está bajo una licencia de Creative Commons Reconocimiento-NoComercial-SinObraDerivada 4.0 Internacional.

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).
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Google™ Scholar:Gómez-Barrena, Enrique - Rosset, Philippe - Gebhard, Florian - Hernigou, Philippe - Baldini, Nicola - Rouard, Hèlene - Sensebé, Luc - Gonzalo-Daganzo, Rosa M. - Giordano, Rosaria - Padilla-Eguiluz, Norma - García Rey, Eduardo - Cordero Ampuero, José - Rubio-Suárez, Juan Carlos - Stanovici, Julien - Ehrnthaller, Christian - Huber-Lang, Markus - Flouzat-Lachaniette, Charles Henri - Chevallier, Nathalie - Donati, Davide Maria - Ciapetti, Gabriela - Fleury, Sandrine - Fernández, Manuel-Nicolás - Cabrera, José-Rafael - Avendaño Solá, Cristina - Montemurro, Tiziana - Panaitescu, Carmen - Veronesi, Elena - Rojewski, Markus Thomas - Lotfi, Ramin - Dominici, Massimo - Schrezenmeier, Hubert - Layrolle, Pierre

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  • Producción científica en acceso abierto de la UAM [18092]

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All the documents from Biblos-e Archivo are protected by copyrights. Some rights reserved.
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