Fibrinogen coated albumin spheres to accelerate bone healing in older adults.

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。

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.