Fibrinogen coated albumin spheres to accelerate bone healing in older adults.
纤维蛋白原涂层白蛋白球可加速老年人的骨骼愈合。
基本信息
- 批准号:10371263
- 负责人:
- 金额:$ 24.66万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-30 至 2023-05-31
- 项目状态:已结题
- 来源:
- 关键词:Adverse effectsAdverse eventAgeAlbuminsAnimalsAnti-Inflammatory AgentsBiological ProductsBiological Response Modifier TherapyBiomechanicsBloodBlood PlateletsBone RegenerationBone TissueBone callusCD34 geneCaringCellsClinicalClinical ManagementClinical TrialsCognitiveDataDevelopmentDoseENG geneEarly MobilizationsEconomicsElderlyEndotheliumEquilibriumEvaluationFemoral FracturesFemurFibrinogenFormulationFractureFracture HealingGoalsHealthHealthcareHeart failureHematopoietic Stem Cell MobilizationHemorrhageHemostatic AgentsHip FracturesHistologicImmuneImpaired healingIncidenceInfectionInflammatoryInjectableInjuryIntellectual PropertyIntravenousKnowledgeLegal patentLifeMeasuresMental DepressionMesenchymal Stem CellsMetabolismModelingMonitorMorbidity - disease rateNanosphereNecrosisOperative Surgical ProceduresOsteopeniaOsteoporosisOutcomePECAM1 genePatientsPharmacological TreatmentPhasePopulationPre-Clinical ModelProcessPropertyPublic HealthRattusRecoveryRegulationResearchRiskRoentgen RaysSalineSignal TransductionSiteSmall Business Innovation Research GrantStructureSuspensionsTestingTimeTissuesTorsionToxic effectTraumaVWF geneVisual impairmentWeightWorkX-Ray Computed Tomographyage relatedagedbasebonebone fragilitybone healingbone strengthcadherin 5chronic woundcostcytokinedietary supplementsdisabilityeconomic impacteffective therapyendothelial stem cellfallsfragility fracturefunctional independencehealinghealthy aginghigh riskimprovedmortalitymortality risknanoscalenovel strategiesnovel therapeuticsolder patientpre-clinicalpreclinical studyprogenitorrepairedsocioeconomicssoft tissuestem cellswoundwound healing
项目摘要
PROJECT SUMMARY
Elderly people are at great risk for bone fracture and they are more likely to suffer complications during fracture
healing. An inefficient healing process exposes the elderly to higher rates of delayed healing or nonunions. The
slow recovery after geriatric fractures dramatically increases risks of degenerative decline, morbidity, and
mortality with a negative socio-economic impact. Available solutions to facilitate bone regeneration are either
invasive or show adverse events in aged people. Intravenous injectable Fibrinogen-coated Albumin
nano-Spheres (FAS) are nanometer-sized spheres with a unique multivalent potential to accelerate chronic
wound healing in multiple soft tissues. FAS has been shown to promote mobilization of progenitor cells of various
lineages including Endothelial Progenitor Cells (EPCs), a cell population responsible also for bone regeneration,
and to counteract inflammatory states. Studies conducted on young rats showed that FAS administered after
fracture promotes the superior strength and structure of the healed bone. By taking advantage of this knowledge,
Fibroplate Inc. proposes to investigate the efficacy of Fibrinoplate-S (FPS), a FAS formulation, as a biological
agent to accelerate the healing of fractured bones in geriatric patients. If successful, FPS could represent a new
therapeutic that can improve the health and functional independence of older adults. In this SBIR Phase I project
Fibroplate aims to accomplish two objectives: 1) Demonstrate the efficacy of FPS in bone fracture healing in
aged pre-clinical rat models. FPS will be administered after femur surgical fracture to assess the bone healing
process through quantitative computed tomography, histological analysis, and biomechanical evaluation of bone
strength. 2) Confirm the mobilization of stem cells induced by FPS to delve deeper into the mechanism of action.
This work will be preparatory of a Phase II project where an extensive IND-enabling preclinical study will be
performed to establish metabolism, dose, and toxicity, together with a long-term assessment of the bone healing
process. The final goal is to obtain FDA approval of FPS as a new healing agent in age-related bone fractures.
By offering an effective treatment for frail patients, Fibroplate is expected to improve and promote healthy aging.
项目摘要
老年人骨折的风险很大,他们更容易在骨折期间遭受并发症
治愈低效的愈合过程使老年人延迟愈合或骨不连的发生率更高。的
老年骨折后恢复缓慢显著增加了退行性衰退、发病率和
造成负面社会经济影响。促进骨再生的可用解决方案有
在老年人中表现出侵入性或不良事件。静脉注射用纤维蛋白原包被白蛋白
纳米球(FAS)是纳米尺寸的球体,具有独特的多价潜力,可加速慢性
多处软组织伤口愈合。FAS已经显示出促进各种造血祖细胞的动员。
包括内皮祖细胞(EPCs)的谱系,一种也负责骨再生的细胞群,
并对抗炎症状态。对年轻大鼠进行的研究表明,
骨折促进愈合骨的上级强度和结构。通过利用这些知识,
纤维板公司建议研究Fibrinoplate-S(FPS)(FAS制剂)作为生物制剂的疗效,
加速老年患者骨折愈合的药剂。如果成功,FPS可能代表一种新的
治疗,可以改善老年人的健康和功能独立性。在SBIR第一阶段项目中,
Fibroplate旨在实现两个目标:1)证明FPS在骨折愈合中的功效,
老年临床前大鼠模型。股骨手术骨折后将给予FPS,以评估骨愈合情况
通过定量计算机断层扫描、组织学分析和骨生物力学评估进行处理
实力2)确认FPS诱导的干细胞动员,深入研究其作用机制。
这项工作将是一个II期项目的准备工作,在该项目中,将进行一项广泛的IND使能临床前研究。
确定代谢、剂量和毒性,以及骨愈合的长期评估
过程最终目标是获得FDA批准FPS作为年龄相关骨折的新愈合剂。
通过为虚弱的患者提供有效的治疗,Fibroplate有望改善和促进健康的衰老。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('Richard Yen', 18)}}的其他基金
A novel agent to manage thrombocytopenic patients with platelet transfusion refractoriness
治疗血小板输注无效的血小板减少症患者的新药
- 批准号:
10250676 - 财政年份:2021
- 资助金额:
$ 24.66万 - 项目类别:
A multivalent, easy-to-use product to mitigate and treat radiation exposure
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10011227 - 财政年份:2019
- 资助金额:
$ 24.66万 - 项目类别:
A multivalent, easy-to-use product to mitigate and treat radiation exposure
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- 批准号:
10160769 - 财政年份:2019
- 资助金额:
$ 24.66万 - 项目类别:
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