Preclinical safety study of a combined therapeutic bone wound dressing for osteoarticular regeneration.
Animals
Bone Regeneration
Cartilage, Articular
/ physiopathology
Cell Line
Combined Modality Therapy
/ methods
Disease Models, Animal
Feasibility Studies
Female
Humans
Male
Mesenchymal Stem Cell Transplantation
/ methods
Mesenchymal Stem Cells
Nanofibers
/ chemistry
Osteoarthritis
/ physiopathology
Rats
Rats, Nude
Sheep
Tissue Engineering
/ methods
Tissue Scaffolds
/ chemistry
Wound Healing
/ physiology
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
14 05 2019
14 05 2019
Historique:
received:
16
10
2018
accepted:
16
04
2019
entrez:
16
5
2019
pubmed:
16
5
2019
medline:
2
7
2019
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 31089136
doi: 10.1038/s41467-019-10165-5
pii: 10.1038/s41467-019-10165-5
pmc: PMC6517440
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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