Project: Development and clinical testing of a novel osteoconductive synthetic bone graft substitutes (NewBone).

Introduction: _x000D_Bone grafts are used to repair and rebuild diseased bones where the human body is unable to heal the bone itself. In order to perform such repair, one needs a porous structure capable of supporting three-dimensional tissue formation. These structures are typically called bone graft. Bone graft must meet specific requirements to achieve its goal : (1) A high porosity and an adequate pore size to allow for diffusion throughout the whole of both bone cells, nutrients and exchange of waste products; (2) A surface that allows cell attachment and migration; and (3) strong enough material to absorb the load from the surround bone. If the graft material collapses, the damaged bone cannot be repaired. Using bone tissue from a donor source poses the risk of transmitting infectious diseases and causing immunogenic responses. To eliminate or greatly reduce this risk, bone tissue undergoes a rigorous washing process that removes all of the living tissue but also decreases the bone cell attachment properties. There has been a huge shortage of supply in tissue donation each year. This has been the biggest market restraint for manufacturers and the market is shifting rapidly toward the use of allografts and bone graft substitutes. Despite extensive research, a bone graft substitute that meets all requirements is yet to be developed. _x000D__x000D_Our novel bone graft substitute:_x000D_Our NewBone graft substitutes is a strong and cost effective synthetic bone grafts that can be shaped into almost any form to accommodate bone defect. The bone graft substitutes have a superior surface design and can be loaded with bioactive ions (e.g. fluoride). Our bone graft substitutes can be manufactured at substantially lower prices than competing bone grafts. Our bone graft substitutes is filed for patenting world-wide (Metal oxide bone graft substitutes, patent application number WO/2008/078164, regional phase entry 08/07/2009). _x000D__x000D_In addition, the novel art of surface modification (also IPR protected) through fluorine ions will result in faster bone healing after implantation, and more bone surrounding the implant than ever seen for ceramic-based bone graft substitutes. Never before has a bone graft substitute with such promising characteristic been reported in literature. Therefore NewBone could be the first mechanical loadable ceramic-based bone graft material on the market._x000D__x000D_Substitute graft materials will also be coated with: 1) polyunsaturated fatty acids (PUFA) and antioxidants, and 2) biomimetic synthetic peptides, to facilitate bone repair and further improve the bone healing. PCT and US patent applications have been filed to protect titanium surfaces photo-activated with PUFA and antixidants. We have also designed and protected world-wide (patent application number WO/2008/078167) an artificial consensus peptide on the basis of sequence similarities between regions in proteins and peptides that are involved in biomineralization (bone, cartilage, enamel, dentin and cementum formation) in order to obtain a peptide that induces and/or stimulates mineral precipitation in biological systems (biomineralization). Genetic engineering of artificial polypeptides offers a novel method of developing materials for tissue regeneration. Due to their shorter length compared to natural proteins, the artificial peptides are easier to produce and allows the use of amino acid analogues which may improve the stability, moreover, they are cheaper and avoid the problems related to immunogenicity and disease transmission._x000D__x000D_Aim of the study : _x000D_The CO aim of the study will be to enter a randomized human clinical trial with at least one of the NewBone prototypes at the end of the project period._x000D__x000D_Feasibility:_x000D_Our research group has already successfully made bone graft substitute out of biocompatible and bone-friendly material that are ten times stronger than market competitors, without even optimising our patent-pending manufacturing methods (Fig 2). It is our belief that further studies on surface modification of these bone graft substitute with fluorine and coating with biomimetic peptides or PUFA with antioxidants would provide even faster and better bone healing properties. The NewBone and NewBone graft material has been successfully tested on bone cells and in rabbits (Fig 2 D). _x000D__x000D_Market: _x000D_The revenue of bone grafts market in Europe for 2007 was 614.2 mill USD with base year market growth rate of 15.1%, according to a recent Frost&Sullivan Report. The bone graft substitute market is relatively new compared to the allograft. It is a fast-growing market and the market is expressing greater interest in the product as the clinical acceptance of bone substitutes is increasing. In 2006, the bone graft substitutes market generated revenues of 40.3 million USD, increasing by 8.5 percent from 2005. The major market participants are Geistlich AG, Straumann Institut AG, Orthovita, Interpore Cross, Wright Medical, Zimmer, Smith & Nephew, and DePuy._x000D_

Acronym NewBone (Reference Number: 5069)
Duration 01/01/2010 - 31/12/2012
Project Topic NewBone is implanted into bone in order to assist the healing and repair of damaged bone. Today standard carries risk of disease transmission, product degradation during storage and mechanical instability. Our patent pending NewBone grafts defeat all these issues and has low production costs.
Project Results
(after finalisation)
Increased mechanical strength of bone graft and have shown excellent in vivo performance
Network Eurostars
Call Eurostars Cut-Off 3

Project partner

Number Name Role Country
4 University of Oslo, Institute for Clinical Dentistry Partner Norway
4 University of the Balearic Islands. Health Sciences Research Institute (IUNICS) Partner Spain
4 Numat Biomedical SL Partner Spain
4 Corticalis AS Coordinator Norway