Clinical trial of autologous bone marrow mesenchymal stem cells and biomaterials for alveolar bone regeneration
This study is part of a large multi-centre EU project entitled REBORNE: Regenerating Bone Defects using New biomedical Engineering approaches.
In the REBORNE project, the group, represented by Professor Emeritus Sølve Hellem, leads and supports a multi-centre study across three countries in which stem cells will be used for jaw bone regeneration. The study is being carried out by PhD candidate Cecilie Gjerde, and it is the first clinical trial involving human subjects to take place in Norway. The first patients have already received transplants at the Department of Clinical Dentistry. This clinical trial is being carried out in parallel with two orthopaedic studies in different European countries in which more than 20 patients have already been treated. Stem cells from patients included in the studies are being expanded on a continuous basis at GMP-certified laboratories, including at Ulm University in Germany. For all relevant projects, the plan is to transfer the treatment and cell expansion activities to a new GMP-certified ex vivo laboratory in Bergen from 2017. The plastic surgery department at Haukeland University Hospital is also taking part in this group in cooperation with the University Medical Center Utrecht in the Netherlands, where they are now using biomaterial instead of the patient's own bone to close the cleft in paediatric patients with cleft lip and palate. This study will be expanded to include the use of mesenchymal stem cells.