Preclinical safety study of a combined therapeutic bone wound dressing for osteoarticular regeneration
Entity
UAM. Departamento de Cirugía; Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ)Publisher
Nature Research (part of Springer Nature)Date
2019Citation
10.1038/s41467-019-10165-5
Nature Communications 10.1 (2019): 1-10
ISSN
2041-1723DOI
10.1038/s41467-019-10165-5Funded by
This work was supported by the ARTiCAR ANR grant (Agence Nationale de la Recherche) and by SATT (Société d’Accélération du Transfert de Technologies) Conectus Alsace. Authors are thankful to “Faculté de Chirurgie Dentaire de Strasbourg” for the financial support.Editor's Version
https://doi.org/10.1038/s41467-019-10165-5Subjects
Arthroplasty; Osteoarticular lesions; Wound dressing; BMP2; Clinical trials; MedicinaRights
© The Author(s) 2019Abstract
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.
Files in this item
Google Scholar:Keller, Laetitia
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Pijnenburg, Luc
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Idoux-Gillet, Ysia
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Bornert, Fabien
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Benameur, Laila
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Tabrizian, Maryam
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Auvray, Pierrick
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Rosset, Philippe
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Gonzalo-Daganzo, Rosa María
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Gómez Barrena, Enrique
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Gentile, Luca
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Benkirane-Jessel, Nadia
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