Nat Commun. 2019 May 14;10(1):2156. doi: 10.1038/s41467-019-10165-5.

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

Keller L^1,2, Pijnenburg L^1,2, Idoux-Gillet Y^1,2, Bornert F^1,2, Benameur L³, Tabrizian M^3,4, Auvray P⁵, Rosset P⁶, María Gonzalo-Daganzo R⁷, Gómez Barrena E⁸, Gentile L^1,2,9,10, Benkirane-Jessel N^11,12.

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.