Reborne is a large scale integrated project corresponding to the call: HEALTH - 2009- 1-4-2.
Pierre Layrolle, PhD
Coordinator of REBORNE
Reborne is an acronym of the project entitled: "Regenerating Bone Defects using New biomedical Engineering approaches".
Bone is the most frequently transplanted tissue with about 1 million procedures annually in Europe. The worldwide market of bone replacement material is currently estimated at 5 billion € with a 10% annual growth.
Autologous bone transplantation is the primary procedure for regenerating large bone defect in patients, but is limited in quantity and lead to complications at the second surgical site. Allogenic bone grafts from tissue bank are used in second intention. However, allografts include the risk of disease transfer and immunologic rejection.
Significant growth opportunities exist for synthetic bone substitutes in association with mesenchymal stem cells from autologous or allergenic sources as alternatives to biological bone grafts in orthopaedic and maxillofacial surgery.
Tissue engineering combines bone marrow cells or mesenchymal stem cells (MSCs), synthetic scaffolds and molecular signals (growth or differentiating factors) in order to form hybrids constructs. In a classical approach, it consists of harvesting bone marrow from a patient, isolating MSCs by their adherence to tissue culture plastic, expanding and differentiating those cells in culture to a sufficient number and then seeding them onto a suitable synthetic scaffold prior to implantation into the same patient.
The objectives of REBORNE is to perform clinical trials using advanced biomaterials and cells triggering bone healing in patients. In order to reach this goal, five phase clinical studies with 20 patients are proposed in 12 clinical centres spread in 8 European countries.
Three orthopeadic trials concerning the treatment of long bone fractures and osteonecrosis of the femoral head in adults or children will be conducted. Clinical research will also concern maxillofacial surgery with bone augmentation prior to dental implants and the reconstruction of cleft palates in children.
Mesenchymal stem cells from autologous or allergenic sources will be associated to calcium phosphate bioceramics, hydrogel for percuteneous injection.
Clinical orthopaedic problems encountered in patients and addressed in REBORNE. From left to right: CT reconstruction in a delayed union, tibial diaphyseal fracture. Early avascular necrosis of the hip, radiological assessment. MRI of the hip, same patient with bilateral hip early necrosis as in previous x-rays.