Preclinical safety study of a combined therapeutic bone wound dressing for osteoarticular regeneration

Laetitia Keller, Luc Pijnenburg, Ysia Idoux-Gillet, Fabien Bornert, Laila Benameur, Maryam Tabrizian, Pierrick Auvray, Philippe Rosset, Rosa María Gonzalo-Daganzo, Enrique Gómez Barrena, Luca Gentile and Nadia Benkirane-Jessel ()
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Laetitia Keller: UMR 1260, Regenerative Nanomedicine (RNM), FMTS
Luc Pijnenburg: UMR 1260, Regenerative Nanomedicine (RNM), FMTS
Ysia Idoux-Gillet: UMR 1260, Regenerative Nanomedicine (RNM), FMTS
Fabien Bornert: UMR 1260, Regenerative Nanomedicine (RNM), FMTS
Laila Benameur: McGill University
Maryam Tabrizian: McGill University
Pierrick Auvray: Parc Technopolitain - Atalante Saint-Malo
Philippe Rosset: Université François Rabeleis
Rosa María Gonzalo-Daganzo: Hospital Universitario Puerta de Hierro Majadahonda
Enrique Gómez Barrena: Hospital La Paz-IdiPAZ and Universidad Autónoma de Madrid
Luca Gentile: UMR 1260, Regenerative Nanomedicine (RNM), FMTS
Nadia Benkirane-Jessel: UMR 1260, Regenerative Nanomedicine (RNM), FMTS

Nature Communications, 2019, vol. 10, issue 1, 1-10

Abstract: Abstract The extended life expectancy and the raise of accidental trauma call for an increase of osteoarticular surgical procedures. Arthroplasty, the main clinical option to treat osteoarticular lesions, has limitations and drawbacks. In this manuscript, we test the preclinical safety of the innovative implant ARTiCAR for the treatment of osteoarticular lesions. Thanks to the combination of two advanced therapy medicinal products, a polymeric nanofibrous bone wound dressing and bone marrow-derived mesenchymal stem cells, the ARTiCAR promotes both subchondral bone and cartilage regeneration. In this work, the ARTiCAR shows 1) the feasibility in treating osteochondral defects in a large animal model, 2) the possibility to monitor non-invasively the healing process and 3) the overall safety in two animal models under GLP preclinical standards. Our data indicate the preclinical safety of ARTiCAR according to the international regulatory guidelines; the ARTiCAR could therefore undergo phase I clinical trial.

Date: 2019
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DOI: 10.1038/s41467-019-10165-5

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