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, Eduardo


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
2018Citation
10.1016/j.biomaterials.2018.03.033
Biomaterials xx (2018): 1-9
ISSN
0142-9612 (print); 1878-5905 (online)DOI
10.1016/j.biomaterials.2018.03.033Funded 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/FP7/241876Editor's Version
https://doi.org/10.1016/j.biomaterials.2018.03.033Subjects
Clinical trial; Bioceramic; ATMP; Expanded autologous BM-hMSC; Non-union; Bone tissue engineering; MedicinaRights
© 2018 The Authors
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).
Files in this item
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
This item appears in the following Collection(s)
Related items
Showing items related by title, author, creator and subject.
-
Osteonecrosis of the femoral head safely healed with autologous, expanded, bone marrow-derived mesenchymal stromal cells in a multicentric trial with minimum 5 years follow-up
Gómez-Barrena, Enrique; Padilla-Eguiluz, Norma G.; Rosset, Philippe; Hernigou, Philippe; Baldini, Nicola; Ciapetti, Gabriela; Gonzalo-Daganzo, Rosa M.; Avendaño Solá, Cristina; Rouard, Hélène; Giordano, Rosaria; Dominici, Massimo; Schrezenmeier, Hubert; Layrolle, Pierre; REBORNE Consortium
2021-02-01 -
Transportation conditions for prompt use of Ex Vivo expanded and freshly harvested clinical-grade bone marrow mesenchymal stromal/stem cells for bone regeneration
Veronesi, Elena; Murgia, Alba; Caselli, Anna; Grisendi, Giulia; Piccinno, Maria Serena; Rasini, Valeria; Giordano, Rosaria; Montemurro, Tiziana; Bourin, Philippe; Sensebé, Luc; Rojewski, Markus T.; Schrezenmeier, Hubert; Layrolle, Pierre; Ginebra, Maria Pau; Panaitescu, Carmen Bunu; Gómez-Barrena, Enrique; Catani, Fabio; Paolucci, Paolo; Burns, Jorge S.; Dominici, Massimo
2014-03-01 -
Implantation of autologous expanded mesenchymal stromal cells in hip osteonecrosis through percutaneous forage: Evaluation of the operative technique
Gómez‐Barrena, Enrique; Padilla‐Eguiluz, Norma G.; REBORNE Consortium
2021-02-12