|
"BIOengineered grafts for Cartilage Healing In Patients" or BIO-CHIP is Horizon 2020 EU project with a total budget of 5.2 million Euros. It is an international consortium of 7 partners from 5 different European countries.
|
|
|
In an effort to overcome the limitations of currently available treatments, the BIO-CHIP project aims at carrying out a phase II clinical trial (Nose To Knee II) for the treatment of traumatic cartilage lesions in the knee, with two main innovations:
|
|
- the use of autologous nasal chondrocytes as a cell source superior to articular chondrocytes and
- the delivery of a tissue graft (tissue therapy) as opposed to a cellular graft (cellular therapy).
|
|
|
The main idea is to formally test the hypothesis that implanting a mature cartilage graft will improve the clinical efficacy, leading to a significant improvement in the main primary outcome, i.e., pain and functionality.
|
|
|
A total of 108 patients will be enrolled in clinical centres in Croatia, Germany, Italy and Switzerland:
|
|
- Universitätsspital Basel (University Hospital Basel), Basel, Switzerland;
- Universitätsklinikum Freiburg (Medical Centre, University of Freiburg), Germany;
- I.R.C.C.S. Istituto Ortopedico Galeazzi (Galeazzi Orthopaedic Institute), Milan, Italy;
- Klinička Bolnica "Sveti Duh" (University Hospital Sveti Duh), Zagreb, Croatia.
|
|
|
In addition to the clinical study, a pre-clinical animal study to expand current clinical indications will be performed. Complex cartilage lesions, including "kissing lesions" (i.e., when two defects are in direct contact with each other) are considered as early degenerative pathologies, with features similar to pre-osteoarthritis, and are therefore excluded from treatment by current methods. The clinical outcome for such untreatable defects is generally knee arthroplasty.
|
