Project description
Hope for cartilage regeneration
Articular cartilage injuries can lead to osteoarthritis, and current therapies are unable to reliably restore cartilage structure and function. This poses a significant problem for millions of people worldwide. With this in mind, the EU-funded BIO-CHIP project is establishing a phase II clinical trial to test the capacity of engineered grafts based on autologous nasal chondrocytes (NC) to induce cartilage regeneration. Specifically, the project aims to define the degree of required maturation for the NC-based grafts and to extend the range of clinical indications to pre-osteoarthritic lesions. BIO-CHIP’s solution will offer hope to those in need of cartilage regeneration and has the potential to generate significant therapeutic and commercial benefits.
Objective
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
Fields of science
- 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)
Funding Scheme
RIA - Research and Innovation actionCoordinator
4051 Basel
Switzerland