N102-179 TITLE: Artificial Tissue Matrices for Bone Repair

TECHNOLOGY AREAS: Biomedical

ACQUISITION PROGRAM: Medical Develop Program/BUMED, Family of Fleet Medical Equipment/MCSC

OBJECTIVE: Develop a completely artificial bone substitute material that mimics human bone and can replace long bones, facial bones and skull bones. This product would be used to accelerate wound healing from Improvised Explosive Device (IED) explosions and facial wounds from snipers which devastate warfighters. Naval forces presently exhibit 90% of the head and neck combats today in Iraq and Afghanistan.

DESCRIPTION: The proposed product will accelerate wound healing. IED destruction of long bone and facial features necessitate bone replacement. "Although several major progresses have been introduced in the field of bone regenerative medicine during the years, current therapies...still have many limitations."1 Current therapies utilize bone harvesting or frozen demineralized freeze-dried cadaver bone when wounds are small. In larger wounds, metal or plastic forms are used. The proposed technology will ideally reduce long-term problems of current methods: limited availability, donor site morbidity, immune response, and disease transmission, & expense including multiple surgeries and long hospital stays & rehabilitation.

Several new methods are currently being studied. Resorbable polymer membranes of the poly (lactide) chemical class are a promising technique for single-step reconstruction of large bone defects2. Bioresorbable materials have the potential to avoid the issues that occur with metallic implants, such as strain, shielding and corrosion3. Synthetic polymers are widely used in biomaterial applications. For example, both collagen type I and hydroxyapatite were found to enhance osteoblast differentiation4. However, new methods and materials are continually being brought to the forefront. An example is the development of nanoceramic matrices, nanoporous biocapsules, and other complex nanostructured materials.5 The newer technologies will likely be better in terms of integration, reduced infection, compatibility, and strength. The potential cost savings would be in excess of 500 million dollars to DoD and would effect a 30 billion dollar market.

PHASE I: Explore alternative potential composites that may suffice as artificial bone and identification of methods that boost the healing process of the recipient bone tissue and facilitate integration of artificial parts.

PHASE II: Prepare and characterize artificial bone matrix prototypes to determine osteoblastic integration and maturation in vitro. These studies will determine feasibility of use for artificial bone prototypes in bone healing. Testing parameters may include, but are not limited to, percentage integration, lack of infection, effect on osteoblast maturation and integration, exclusion of non-osteoblast host materials, graft and host cell survival. Prototypes that demonstrate feasibility will be further developed and optimized for Phase III testing in maxillofacial, orthopedic, and neurosurgical animal models.

PHASE III: Test artificial bone matrix prototypes in pre-clinical animal models of trauma for the purposes of safety and efficacy. Successful demonstration will ideally result in submission to Phase I Clinical Trials for FDA approval.

PRIVATE SECTOR COMMERCIAL POTENTIAL/DUAL-USE APPLICATIONS The potential cost savings would be in excess of 500 million dollars to DoD and would effect a 30 billion dollar commercial market. The artificial bone is applicable to non-war-related wounds (trauma such as car accidents, diseases such as bone cancer) and can be used in any medical setting.

REFERENCES:
1. Salgado et al. 2004. Bone tissue engineering: state of the art and future trends. Macromol Biosci. 4(8):743-65.

2. Meinig, R. 2010. Clinical use of resorbable polymeric membranes in the treatment of bone defects. Orthopedic Clinics of North America. 41:1.

3. Collagen-Hydroxyapatite Composites for Hard Tissue Repair, Eur Cells Materials, 2006, 11:43-56 (http://www.ecmjournal.org/journal/papers/vol011/pdf/v011a06.pdf)

4. Xie, J et al. 2004. Osteoblasts respond to hydroxyapatite surfaces with immediate changes in gene expression. J Biomed Mater Res A. 71:108-117.

5. Nanoceramic Matrices: Biomedical Applications, Am J Biochem Biotech 2006, 2(2): 41-48 (http://www.scipub.org/fulltext/ajbb/ajbb2241-48.pdf)

6. Kalorama''s Implant-Based Dental Reconstruction: The Worldwide Dental Implant and Bone Graft Market, 2nd Edition

KEYWORDS: Artificial Bone; Wound Healing; IEDs; maxillofacial; orthopedic; Accelerated Recovery

** TOPIC AUTHOR (TPOC) **

DoD Notice:   Between April 21 and May 19, 2010, you may talk directly with the Topic Authors to ask technical questions about the topics. For reasons of competitive fairness, direct communication between proposers and topic authors is not allowed starting May 19, 2010, when DoD begins accepting proposals for this solicitation.

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