Design and development of a bioresorbable bone graft

生物可吸收骨移植物的设计和开发

• 批准号: 8234375
• 负责人: JASON D SMITH
• 金额: $ 10万
• 依托单位: CARMELL THERAPEUTICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2013-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8234375
• 关键词: Aging; Allogenic; Allografting; Animal Model; Autologous Transplantation; Biocompatible; Biocompatible Materials; Biological; Biological Assay; Biological Testing; Biomechanics; Blood; Blood Platelets; Bone Growth; Bone Matrix; Bone Substitutes; Bone Transplantation; Cadaver; Calvaria; Cells; Chemicals; Clinical; Clinical Trials; Coagulation Process; Collagen; Coupled; Crosslinker; Cytoplasmic Granules; Data; Defect; Development; Devices; Disease; Drug Formulations; Engineering; Evaluation; Extracellular Matrix; Family; Feasibility Studies; Filler; Forearm; Freeze Drying; Funding; Future; General Hospitals; General Population; Glycerol; Goals; Growth; Growth Factor; Hand; Heating; Human; Knowledge; Licensing; Malignant Neoplasms; Manufactured Materials; Marketing; Measures; Mechanics; Mediating; Medical Device; Modeling; Molds; Mus; Muscle; Natural regeneration; Operating Rooms; Orthopedics; Oryctolagus cuniculus; Osteogenesis; Outcome; Particle Size; Paste substance; Pathway interactions; Phase; Plasma; Plasticizers; Plastics; Polymers; Population; Powder dose form; Preparation; Procedures; Process; Property; Radial; Rattus; Repair Material; Research; Research Personnel; Safety; Secure; Shapes; Site; Small Business Innovation Research Grant; Solid; Source; Spinal Fusion; Statistical Study; Structure; Surgeon; Techniques; Technology; Testing; Therapeutic; Time; Total Hip Replacement; Transplanted tissue; Trauma; Universities; Viscosity; Weight-Bearing state; Wound Healing; aging population; base; biomaterial compatibility; bone; bone healing; cartilage repair; chemical property; clinical material; cold temperature; commercialization; cost; cost effective; design; disease transmission; expectation; falls; genipin; implantable device; improved; in vivo; innovation; long bone; meetings; osteogenic; phase 1 study; physical property; pressure; public health relevance; recombinant human bone morphogenetic protein-2; repaired; scaffold; technological innovation

DESCRIPTION (provided by applicant): The long-term goal of this project is to develop a safe, cost-effective, off-the-shelf, and well characterized bone filler material based on plastics derived from blood plasma. Over 800,000 bone procedures are performed in the US per year, and with the aging US population, this number will only continue to grow. However, current materials, including autografts (e.g. demineralized bone matrix (DBM)), allografts, and engineered biomaterials, all fall short of clinical expectations for reasons such as cost, disease transmission concerns, bone donation issues and complications, and lack of well characterized and consistently performing products. Blood plasma-based plastics have the potential to overcome these limitations. In Phase I Carmell Therapeutics demonstrated that blood plasma-based plastics are biocompatible, biodegradable, bioactive, and form bone in a mouse calvarial defect model. In Phase II Carmell seeks to develop a putty-form of its plastic and obtain safety and efficacy data for use in a premarket approval application to the FDA. To achieve this, the putty will be designed to have similar physical properties to those of DBM-based putties while maintaining the biocompatibility and bioactivity properties of the original blood plasma-based plastic. An accompanying putty delivery device will also be developed. The osteoinductive potential of the product will be tested in a rat muscle-pocket heterotopic bone model. The ability of the product to repair a rabbit long bone radial defect will also be tested in a large, statistical study. Finally, a battery of biological tests will be performed to satisfy FDA- mandated ISO 10993 standards for the biological evaluation of medical devices. PUBLIC HEALTH RELEVANCE: The aging population coupled with the general population's increased activity has raised demand for effective bone graft materials. Current clinical materials fall short of many of the expectations of clinicians for reasons such as inconsistent outcomes, inadequate supply, and cost. Carmell Therapeutics has developed a material made from human blood byproducts that has the potential to be a safe, cost-effective, off-the-shelf, and consistent bone graft therapy.

描述（由申请人提供）：该项目的长期目标是开发一种安全，成本效益，现成的且具有良好特征的骨填充物材料，该材料基于来自血浆的塑料。每年美国进行超过80万个骨手术，随着美国老龄化的人口，这一数字只会继续增长。但是，包括自体移植物（例如脱矿质骨基质（DBM）），同种异体移植物和工程生物材料在内的当前材料，由于成本，疾病传播问题，骨骼捐赠问题和复杂性以及缺乏表征性能良好，表现良好和稳定的产品，所有这些材料都没有临床期望。基于血浆的塑料有可能克服这些局限性。在第一阶段，Carmell Therapeatics表明，基于血浆的塑料是生物相容性，可生物降解，生物活性和形成骨骼中的骨骼中的骨骼。在第二阶段，卡梅尔（Carmell）试图开发其塑料的油腻形式，并获取安全性和功效数据，以用于FDA的前市场批准申请。为了实现这一目标，该油灰将其设计与基于DBM的推杆具有相似的物理特性，同时保持原始血浆基于基于血浆的塑料的生物相容性和生物活性特性。还将开发随附的油灰送货设备。该产品的骨诱导潜力将在大鼠肌肉口袋的异位骨模型中进行测试。在一项大型统计研究中，产品修复兔长骨径向缺陷的能力也将进行测试。最后，将进行一系列生物测试，以满足FDA强制性的ISO 10993标准，用于医疗设备的生物学评估。 公共卫生相关性：老龄化的人口加上普通人群的增加活动增加了对有效骨移植材料的需求。目前的临床材料落在临床医生的许多期望之外，原因包括不一致的结果，供应不足和成本。 Carmell Therapeutics开发了一种由人类血液副产品制成的材料，该材料有可能成为安全，成本效益，现成和一致的骨移植疗法。