Bone is the most transplanted tissue in Europe. In bone regeneration procedures, surgeons take a piece of bone from the patient and transplant it to the site where it is needed. Bone transplant has several drawbacks: harvesting requires a second surgical site; the bone stock is limited; pain and other complications may be encountered at the harvest site; and autologous bone is often resorbed very rapidly. Therefore, the potential and value of stem cell-based therapies was explored in the early 1990 when therapeutically relevant tissue-supportive cells as mesenchymal stem cells (MSC) were applied for the regeneration of bone. However, only few early stage clinical studies with a limited number of patients have proven safety of this novel regenerative treatment.
The promising data from a recent pilot clinical trial in 11 patients in Bergen paved the way for improved well-designed trials utilizing stem cells. Our vision is to optimise and perform multi-centre clinical trials in Norway and Spain. Later phase clinical trials will be performed aiming to assess the safety and effectiveness of bone marrow derived autologous MSCs delivered with a scaffold and covered with a barrier membrane, for restoring bone. This new interventional therapy will be compared retrospectively if the use of MSC and biomaterial as bone grafting engineered construct is equally good or better than the gold standard of bone augmentation, i.e. the autologous bone graft.
Further, the project will allow merging the new innovative diagnostic concept, liquid biopsy, with a cutting edge technology, mass cytometry which will be employed to monitor the blood borne cells both during the preclinical as well as the clinical trials. The knowledge generated from the project will be used to develop translational approaches for regenerative cell therapies of different types of bone defects.