Bergen, Norway: A new and pioneering study from the University of Bergen (UiB) shows that a patient’s stem cells can be used to grow new bone. This could help millions of people who have partially weak teeth and have insufficient bone to place dental implants.
The Maxibone project has now been launched, coordinated by Pierre Layrolle, Inserm, University of Nantes, France and Kamal Mostafa, UiB, Norway. This trial is among the few ongoing randomized trials using mesenchymal stem cells. Maxibone aims to create personal bone regeneration for patients with missing bones in the jaw, for example – which can happen after cancer or a traffic accident.
The biological material used to make new bone comes from the patients’ own stem cells.
This project has European funding of 6 million euros. The consortium brings together 12 partners from five European countries (Norway, Spain, France, Denmark and Germany) including research laboratories, academic hospitals, cellular therapy units, a biomaterials company, and a world leader in dental implants.
In the project, a randomized controlled trial of 150 patients will compare the safety and efficacy of self-implanted stem cells and biomaterials of calcium phosphate with autologous bone grafting in alveolar bone augmentation prior to dental implantation. In a previous European project Reborne, the clinical safety of this regenerative strategy was demonstrated in eleven patients at the University of Bergen, Norway.
This regenerative method involves, in simple terms, collecting bone marrow from
The patient’s thigh. These stem cells are being expanded in the laboratories located in
Institute of Transfusion Medicine and Immunotherapy, Ulm, Germany and Therapy Cellulire de Cretel Center, France. After two weeks, mesenchymal stem cells are shipped to the clinical center. Cells mixed with biomaterials are grafted onto the edges of the maxillary and mandibular bones to increase their size. In a control arm, autologous bone is harvested from the mandibular branch and implanted at the site of magnification. A synthetic non-absorbable membrane is used to cover the grafts
And to guide tissue regeneration.
After five months, a cone beam CT is performed to assess the size of the bone for insertion of dental implants. Basic biopsies are analyzed by synchrotron, micro tomography, and histology. Dental implants are placed and fused for three months before being loaded with synthetic elements.
In this clinical study, 150 patients will be recruited and randomized to
The control group consisted of a bone graft (the gold standard) or a receiving test group
A mixture of self cultured stem cells and biomaterials. Recruit
It will be offered in centers in Norway, Spain, Germany, Denmark and France. This multi-center experiment is led by Associate Professor Cecilie Gerdi, UiB, Norway and Professor Mariano Sanz, Complutense University in Madrid, Spain.
The Maxibone clinical trial takes on a wider dimension, which should lead to commercialization of this regenerative method within four years. It will ensure medical imaging, direct measurements and histology of basic biopsies before dental implantation
Bone regeneration evaluation.
Last week, the first patients in the test group received stem cells. This event took place in the University of Bergen clinic, and the next patient is already ready for the bone marrow harvest. In parallel, other medical centers are ready to start registering patients.
CONTACT on behalf of the sponsor:
Professor at the University of Bahrain Kamal Mustafa – [email protected] – +4798497607
Ass Professor at UiB, Cecilie Gjerde – [email protected] – +47 98 69 84 05
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