Record #181657 - GSI Repository

BIO-CHIP

BIOengineered grafts for Cartilage Healing In Patients (BIO-CHIP)

Coordinator	UNIVERSITAETSKLINIKUM FREIBURG ; Istituto Ortopedico Gaetano Pini ; ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ; MEDACTA INTERNATIONAL SA ; University of Basel ; FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. ; University of Zagreb ; University of Würzburg
Grant period	2015-11-01 - 2020-10-31
Funding body	European Union
Call number	H2020-PHC-2015-single-stage_RTD
Grant number	681103
Identifier	G:(EU-Grant)681103

Note: 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

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Record created 2015-12-04, last modified 2023-02-08

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