Description du projet
Un espoir pour la régénération du cartilage
Les lésions du cartilage articulaire peuvent conduire à l’arthrose, et les thérapies actuelles sont incapables de restaurer de manière fiable la structure et la fonction du cartilage. Cela pose un problème important pour des millions de personnes dans le monde. Dans cette optique, le projet BIO-CHIP, financé par l’UE, met en place un essai clinique de phase II afin de tester la capacité des greffons fabriqués à partir de chondrocytes nasaux (CN) autologues à induire une régénération du cartilage. Plus précisément, le projet vise à définir le degré de maturation requis pour les greffons à base de CN et à étendre la gamme des indications cliniques aux lésions pré-arthrosiques. La solution de BIO-CHIP offrira de l’espoir aux personnes nécessitant une régénération du cartilage et a le potentiel de générer des avantages thérapeutiques et commerciaux significatifs.
Objectif
Spontaneous healing of articular cartilage injuries is poor and untreated defects predispose to osteoarthritis. Current therapies, including innovative autologous cell-based treatments, cannot predictably and reproducibly restore cartilage structure and function.
BIOCHIP will carry out a multicenter, prospective phase II clinical trial to treat knee cartilage injuries using engineered grafts based on autologous nasal chondrocytes (NC). As compared to typically employed articular chondrocytes, NC have a higher and more reproducible capacity to generate mature cartilage tissues. Importantly, molecular/mechanical characterization, large size animal studies and a phase I trial carried out by BIOCHIP partners have already shown the compatibility of NC upon implantation in a joint, with promising preliminary clinical results.
BIO-CHIP’s specific objectives are:
(1) To test the hypothesis that the maturation of NC-based cartilage grafts improves the clinical efficacy in the treatment of cartilage lesions (108 patients will be recruited to reach statistical significance)
(2) To extend the range of clinical indications of NC-based grafts to so far untreatable pre-osteoarthritic lesions (‘kissing’ cartilage lesions in a sheep model)
BIO-CHIP capitalizes on clinical experience of 4 reference centers for cartilage surgery, on established GMP manufacturing capacity and on preparation for commercial exploitation by a strong orthopedic device company. Demonstration of therapeutic efficacy of the new treatment will address a large clinical need (over 2 million cartilage defects/year worldwide), improve quality of life (reduce pain & disability in the young, delay prosthetic implants in the elderly), exploit a commercial opportunity (prospected revenues of up to 130 million €/year) and reduce healthcare costs (estimated 12,000€ healthcare savings/procedure). BIO-CHIP will consolidate the currently leading role of Europe in the development of cell-based cartilage regeneration strate
Champ scientifique
- engineering and technologyenvironmental biotechnologybioremediationbioreactors
- medical and health sciencesclinical medicinesurgery
- social sciencessociologyindustrial relationsautomation
- engineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imaging
- medical and health sciencesmedical biotechnologyimplants
Programme(s)
Régime de financement
RIA - Research and Innovation actionCoordinateur
4051 Basel
Suisse