Design and development of a bioresorbable bone graft
生物可吸收骨移植物的设计和开发
基本信息
- 批准号:8234375
- 负责人:
- 金额:$ 10万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AgingAllogenicAllograftingAnimal ModelAutologous TransplantationBiocompatibleBiocompatible MaterialsBiologicalBiological AssayBiological TestingBiomechanicsBloodBlood PlateletsBone GrowthBone MatrixBone SubstitutesBone TransplantationCadaverCalvariaCellsChemicalsClinicalClinical TrialsCoagulation ProcessCollagenCoupledCrosslinkerCytoplasmic GranulesDataDefectDevelopmentDevicesDiseaseDrug FormulationsEngineeringEvaluationExtracellular MatrixFamilyFeasibility StudiesFillerForearmFreeze DryingFundingFutureGeneral HospitalsGeneral PopulationGlycerolGoalsGrowthGrowth FactorHandHeatingHumanKnowledgeLicensingMalignant NeoplasmsManufactured MaterialsMarketingMeasuresMechanicsMediatingMedical DeviceModelingMoldsMusMuscleNatural regenerationOperating RoomsOrthopedicsOryctolagus cuniculusOsteogenesisOutcomeParticle SizePaste substancePathway interactionsPhasePlasmaPlasticizersPlasticsPolymersPopulationPowder dose formPreparationProceduresProcessPropertyRadialRattusRepair MaterialResearchResearch PersonnelSafetySecureShapesSiteSmall Business Innovation Research GrantSolidSourceSpinal FusionStatistical StudyStructureSurgeonTechniquesTechnologyTestingTherapeuticTimeTotal Hip ReplacementTransplanted tissueTraumaUniversitiesViscosityWeight-Bearing stateWound Healingaging populationbasebiomaterial compatibilitybonebone healingcartilage repairchemical propertyclinical materialcold temperaturecommercializationcostcost effectivedesigndisease transmissionexpectationfallsgenipinimplantable deviceimprovedin vivoinnovationlong bonemeetingsosteogenicphase 1 studyphysical propertypressurepublic health relevancerecombinant human bone morphogenetic protein-2repairedscaffoldtechnological innovation
项目摘要
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基于血浆衍生塑料的安全、具有成本效益、现成且特征良好的骨填充材料。美国每年进行超过 800,000 例骨骼手术,并且随着美国人口老龄化,这一数字只会继续增长。然而,目前的材料,包括自体移植物(例如脱矿骨基质(DBM))、同种异体移植物和工程生物材料,由于成本、疾病传播问题、骨捐赠问题和并发症以及缺乏充分表征等原因,均未达到临床预期。和始终如一的性能产品。血浆基塑料有可能克服这些限制。在第一阶段,Carmell Therapeutics 证明基于血浆的塑料具有生物相容性、可生物降解性、生物活性,并且可以在小鼠颅骨缺损模型中形成骨骼。在第二阶段,卡梅尔寻求开发一种油灰形式的塑料,并获得安全性和功效数据,用于向 FDA 提交上市前批准申请。为了实现这一目标,腻子将被设计为具有与基于 DBM 的腻子相似的物理特性,同时保持原始血浆基塑料的生物相容性和生物活性特性。还将开发配套的腻子输送装置。该产品的骨诱导潜力将在大鼠肌袋异位骨模型中进行测试。该产品修复兔子长骨径向缺损的能力也将在一项大型统计研究中进行测试。最后,将进行一系列生物学测试,以满足 FDA 规定的医疗器械生物学评估 ISO 10993 标准。
公共健康相关性:人口老龄化加上一般人群活动的增加增加了对有效骨移植材料的需求。由于结果不一致、供应不足和成本等原因,目前的临床材料未能达到临床医生的许多期望。 Carmell Therapeutics 开发了一种由人体血液副产品制成的材料,有可能成为一种安全、经济、现成且一致的骨移植疗法。
项目成果
期刊论文数量(0)
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JASON D SMITH其他文献
JASON D SMITH的其他文献
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{{ truncateString('JASON D SMITH', 18)}}的其他基金
An antimicrobial-eluting bioresorbable bone filler for orthopaedic application
用于骨科应用的抗菌洗脱生物可吸收骨填充剂
- 批准号:
8712646 - 财政年份:2014
- 资助金额:
$ 10万 - 项目类别:
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:
7905429 - 财政年份:2008
- 资助金额:
$ 10万 - 项目类别:
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:
7771967 - 财政年份:2008
- 资助金额:
$ 10万 - 项目类别:
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:
8046391 - 财政年份:2008
- 资助金额:
$ 10万 - 项目类别:
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