Preclinical safety study of a combined therapeutic bone wound dressing for osteoarticular regeneration.
basic_science · Level V
Where this comes from
- Record sourced from PubMed, PMID 31089136.
- Also identified by DOI 10.1038/s41467-019-10165-5 and PMC identifier 6517440.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.
Medical subject headings
- Cartilage, Articular
- Mesenchymal Stem Cell Transplantation
- Nanofibers
- Osteoarthritis
- Tissue Scaffolds