Descrizione del progetto
Speranza per la rigenerazione della cartilagine
Le lesioni della cartilagine articolare possono portare all’osteoartrite e le attuali terapie non sono in grado di ripristinare in modo affidabile la struttura e la funzione della cartilagine. Ciò rappresenta un problema considerevole per milioni di persone in tutto il mondo. In quest’ottica, il progetto BIO-CHIP, finanziato dall’UE, sta avviando una sperimentazione clinica di fase II per testare la capacità degli innesti ingegnerizzati a base di condrociti nasali autologhi di indurre la rigenerazione della cartilagine. In particolare, il progetto intende definire il grado di maturazione richiesto per gli innesti a base di condrociti nasali ed estendere la gamma di indicazioni cliniche alle lesioni pre-osteoartritiche. La soluzione di BIO-CHIP offrirà speranza a coloro che necessitano di rigenerazione della cartilagine e potrebbe generare notevoli benefici terapeutici e commerciali.
Obiettivo
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
Campo scientifico
- engineering and technologyenvironmental biotechnologybioremediationbioreactors
- medical and health sciencesclinical medicinesurgery
- social sciencessociologyindustrial relationsautomation
- engineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imaging
- medical and health sciencesmedical biotechnologyimplants
Programma(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-PHC-2015-single-stage_RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
4051 Basel
Svizzera