Increased emphasis is being placed on translational research discoveries, which will bring the use of stem cells in laboratory studies into the clinical setting. However, only few early stage clinical studies with a limited number of patients have proven safety of this novel regenerative treatment. According to the clinical database (www.clinicaltrials.gov) and Medline, it appears that our research is at the forefront of regenerative medicine as we have successfully performed an early stage pilot clinical study using stem cell therapy in 11 patients for reconstruction of alveolar bone with excellent results at the 24 month examination. These results would pave the way for improved and well-designed phase II clinical trial using stem cell therapy for bone regeneration.
Therefore, 20 patients will be recruited and treated is a phase II clinical trial aiming for regeneration of severely resorbed mandibular bone to dental implants. The primary objective of this clinical study will be to assess the safety and effectiveness of the stem cell therapy and biomaterials to regenerate mandibular bone in width and height in order to enable adequate implant placement. This new interventional therapy will be compared retrospectively if the use of bone marrow mesenchymal stem cells (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 from mandibular ramus.
Bone augmentation and regeneration will be achieved by implantation of a synthetic bone substitute and culture expanded autologous MSC covered by a resorbable membrane. Innovative medical imaging and histology of core biopsies before dental implants will ensure the evaluation of bone regeneration in patients. The safety and efficiency of the treatment will be assessed by evaluating the occurrence of adverse effects, monitoring cells after transplantation, assessing acceptability of this approach and its impact on the patient’s quality of life and other patient reported outcomes. The data and knowledge generated from the project will be utilized to develop translational approaches for regenerative therapies of different types of bone defects and support the establishment of the new Ex Vivo Laboratory planned to be opened in Bergen at Haukeland University Hospital.