• Biomaterials · Mar 2019

    Multicenter Study

    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.

    • Enrique Gómez-Barrena, Philippe Rosset, Florian Gebhard, Philippe Hernigou, Nicola Baldini, Helène Rouard, Luc Sensebé, Rosa M Gonzalo-Daganzo, Rosaria Giordano, Norma Padilla-Eguiluz, Eduardo García-Rey, José Cordero-Ampuero, Juan Carlos Rubio-Suárez, Julien Stanovici, Christian Ehrnthaller, Markus Huber-Lang, Charles Henri Flouzat-Lachaniette, Nathalie Chevallier, Davide Maria Donati, Gabriela Ciapetti, Sandrine Fleury, Manuel-Nicolás Fernandez, José-Rafael Cabrera, Cristina Avendaño-Solá, Tiziana Montemurro, Carmen Panaitescu, Elena Veronesi, Markus Thomas Rojewski, Ramin Lotfi, Massimo Dominici, Hubert Schrezenmeier, and Pierre Layrolle.
    • Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: enrique.gomezbarrena@uam.es.
    • Biomaterials. 2019 Mar 1; 196: 100-108.

    BackgroundORTHO-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.MethodsTwenty-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.FindingsWith 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).InterpretationSafety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic.FundingEU-FP7-HEALTH-2009, REBORNE Project (GA: 241876).Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…