Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application

用于颅面/颌面应用的抗菌可生物降解骨移植物

• 批准号: 9201920
• 负责人: ARASH ASLANI
• 金额: $ 52.98万
• 依托单位: N2 BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9201920
• 关键词: Absorbable Implants; Alloys; Anti-Bacterial Agents; Antibiotics; Biological; Body Fluids; Bone Growth; Bone Transplantation; California; Ceramics; Chemicals; Clinical; Defect; Devices; Equipment; Excision; Face; Gentamicins; Glycolates; Growth; HA coating; Healed; Health Care Costs; Housing; Hydroxyapatites; Immersion Investigative Technique; Implant; In Vitro; Incidence; Industry; Infection prevention; Lead; Magnesium; Mandible; Maxilla; Mechanics; Metals; Modeling; Modification; Operative Surgical Procedures; Orthopedic Fixation Devices; Orthopedic Surgery procedures; Orthopedics; Osseointegration; Outcome; Pain; Patients; Pediatric Surgical Procedures; Performance; Phase; Polyesters; Polymers; Procedures; Process; Production; Property; Rattus; Research; Schedule; Services; Site; Source; Stainless Steel; Surface; Surgical complication; Surgical sutures; System; Temperature; Testing; Tissues; Titania; Titanium; Universities; Vertebral column; antimicrobial; base; biomaterial compatibility; bone; clinically relevant; cold temperature; commercialization; copolymer; cost; craniofacial; healing; improved; in vivo; interest; maxillofacial; operation; oral surgery specialty; particle acceleration; poly-L-lactic acid; programs; research and development; sample fixation; success; surgery material

Project Summary Magnesium (Mg) and its alloys have attracted increasing interest for use as biodegradable implants, such as fixation devices for orthopedic and cranio-maxillofacial surgeries, due to their promising mechanical and biological properties, as well as their ability to degrade and resorb in the body. The overall aim of the Phase II program is to extend encouraging Phase I results in which biodegradable magnesium beads, coated with hydroxyapatite (HA) with an incorporated antibiotic, showed significant reduction of bacterial growth-rate and retained their mechanical properties during extended immersion in simulated body fluid. Uncoated controls lost much of their mechanical strength during the immersion tests. Phase II will extend the promising results by optimizing the hydroxyapatite coating, which is applied by N2 Biomedical's proprietary process to produce a thin, durable layer at low temperature, thereby retaining the properties of the HA source material and viability of temperature-sensitive material, such as an antibiotic. We will continue to develop a coating in which the HA will not only help initiate bone growth but also regulate the dissolution rate of the magnesium substrate and the release of the antibiotic, thus preventing infection. In vivo studies will use optimized HA-coated Mg implants in a rat model to study initiation of bone-growth, implant dissolution, and antibacterial efficacy of the antibiotic that is incorporated in the coating. Success of this program could lead to reduction or elimination of the present need for a subsequent operation to remove an implant or beads from the patient. Overall success through Phase III commercialization could start a revolution in the implant industry and a significant shift of the clinical paradigm in craniofacial and orthopedic surgery by reducing cost and pain associated with revision surgeries for implant removal.

项目概要 镁 (Mg) 及其合金作为可生物降解植入物引起了越来越多的兴趣，例如 用于骨科和颅颌面手术的固定装置，由于其具有良好的机械和 生物特性，以及它们在体内降解和再吸收的能力。二期总体目标 计划的目的是扩展令人鼓舞的第一阶段结果，其中可生物降解的镁珠，涂有 羟基磷灰石 (HA) 与抗生素结合，显示出细菌生长速度显着降低， 在模拟体液中长时间浸泡期间保持其机械性能。未涂层的控制丢失 在浸没测试期间，它们的大部分机械强度都受到影响。第二阶段将延长有希望的结果 优化羟基磷灰石涂层，该涂层采用 N2 Biomedical 的专有工艺生产 在低温下形成薄而耐用的层，从而保留 HA 源材料的特性和活力 温度敏感材料，例如抗生素。我们将继续开发一种涂层，其中 HA 将 不仅有助于促进骨骼生长，还可以调节镁基质和镁基质的溶解速率 释放抗生素，从而预防感染。体内研究将使用优化的 HA 涂层镁植入物 大鼠模型，用于研究骨生长的启动、植入物溶解以及抗生素的抗菌功效 被纳入涂层中。该计划的成功可能会减少或消除目前的 需要进行后续手术从患者体内取出植入物或珠子。总体成功通过 III 期商业化可能会引发种植体行业的一场革命和临床的重大转变 通过降低翻修手术相关的成本和疼痛，成为颅面和骨科手术的范例 用于植入物移除。