PFI:AIR-TT: Biocompatibility and Biomechanical Validation of Cellulose-Based Hydrogels for Intervertebral Disc Repair

PFI:AIR-TT:用于椎间盘修复的纤维素基水凝胶的生物相容性和生物力学验证

基本信息

  • 批准号:
    1701120
  • 负责人:
  • 金额:
    $ 20万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
    Standard Grant
  • 财政年份:
    2017
  • 资助国家:
    美国
  • 起止时间:
    2017-07-15 至 2019-07-31
  • 项目状态:
    已结题

项目摘要

This PFI: AIR Technology Translation project focuses on translating a novel injectable biomaterial derived from the plant polysaccharide, cellulose, to treat injuries or degeneration of the intervertebral disc (IVD).   These materials are important because they address a clinical problem (IVD degeneration) that is the most common diagnosis for lower back pain, a debilitating condition that affects 15-30% of the United States population, with associated annual costs of $100 billion. The project will result in valuable proof-of-concept data demonstrating safety and efficacy of these cellulosic biomaterials in a small animal in vivo model and a large animal explant model. Successful completion will motivate further validation in a large animal preclinical injury model prior to clinical studies. The cellulosic materials are unique in that they are plant-derived, gel in situ via a dual coupling mechanism and allow for the incorporation of cells and growth factors for combination therapies.  These features provide the advantages of an extensive safety profile, cost effectiveness, minimally invasive delivery, enhanced stability and therapeutic versatility when compared to the leading competing materials under development in this market space.  This project addresses several technology gaps as it translates from research discovery toward commercial application of a novel material for IVD repair. Current surgical treatment options (i.e., discectomy) are inadequate for long-term disease management, and existing commercial implants (i.e., total disc replacement) do not sufficiently restore disc structure and function. Replacing the gelatinous nucleus pulposus tissue of the IVD with an injectable material may help restore IVD mechanical functionality. Several products are under development for nucleus pulposus replacement, with none approved for use in the United States. This project focuses on the use of injectable cellulose-based hydrogels that form in situ in the intradiscal space to replace resected nucleus pulposus tissue. The proposed validation experiments will characterize an optimized cellulosic gel formulation previously shown to be stable and restore disc properties under axial compression. The studies will determine the foreign body reaction in a small animal model as well as the mechanical properties and failure mechanisms under cyclic loading in bending using a large animal spine motion segment injury model. Many of the competing products under development have been found to have poor biocompatibility or exhibited migration and reherniation. Also, few prior studies have been capable of evaluating candidate materials under such "worst-case-scenario" bending conditions. As such, they have met with limited success. In addition, personnel involved in this project include undergraduate and graduate students who will receive training in innovation and technology commercialization through translational medicine courses, and via regular interactions with potential strategic partners, participation in innovation and commercialization conferences and symposia, and small business grant proposal preparation.The project engages experts in orthopaedic surgery from the Icahn School of Medicine at Mount Sinai and an experienced biomedical device industry professional to guide the biomechanical evaluation studies and commercialization aspects, respectively, in this effort to translate the proposed technology from research discovery toward commercial reality.
这个PFI: AIR技术翻译项目的重点是翻译一种从植物多糖、纤维素中提取的新型可注射生物材料,以治疗椎间盘损伤或退变(IVD)。这些材料很重要,因为它们解决了一个临床问题(IVD变性),这是下背部疼痛最常见的诊断,这是一种使人衰弱的疾病,影响了15-30%的美国人口,相关的年成本为1000亿美元。该项目将产生有价值的概念验证数据,证明这些纤维素生物材料在小型动物体内模型和大型动物外植体模型中的安全性和有效性。成功完成将激励在临床研究之前在大型动物临床前损伤模型中进一步验证。纤维素材料的独特之处在于它们是植物源性的,通过双偶联机制原位凝胶化,允许细胞和生长因子的结合进行联合治疗。这些特点提供了广泛的安全性、成本效益、微创输送、增强的稳定性和治疗的多功能性等优势,与该市场领域正在开发的领先竞争材料相比。该项目解决了从研究发现到IVD修复新材料的商业应用的几个技术空白。目前的手术治疗方案(如椎间盘切除术)不足以长期治疗疾病,现有的商业植入物(如全椎间盘置换术)不能充分恢复椎间盘的结构和功能。用可注射材料替代IVD的胶状髓核组织可能有助于恢复IVD的机械功能。一些产品正在开发用于髓核替代,但没有一个在美国被批准使用。这个项目的重点是使用可注射的纤维素基水凝胶,这种水凝胶在椎间盘内空间原位形成,以取代切除的髓核组织。提出的验证实验将表征优化的纤维素凝胶配方,该配方先前显示在轴向压缩下稳定并恢复磁盘特性。研究将在小动物模型中确定异物反应,并在大动物脊柱运动节段损伤模型中确定弯曲循环载荷下的力学性能和破坏机制。许多正在开发的竞争性产品已被发现具有较差的生物相容性或表现出迁移和再疝。此外,很少有先前的研究能够在这种“最坏情况”的弯曲条件下评估候选材料。因此,他们取得了有限的成功。此外,参与该项目的人员包括本科生和研究生,他们将通过转化医学课程、与潜在战略合作伙伴的定期互动、参与创新和商业化会议和专题讨论会、以及小企业资助提案的准备,接受创新和技术商业化方面的培训。该项目聘请了来自西奈山伊坎医学院的整形外科专家和经验丰富的生物医学设备行业专业人士,分别指导生物力学评估研究和商业化方面的工作,努力将拟议的技术从研究发现转化为商业现实。

项目成果

期刊论文数量(2)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Injectable cellulose-based hydrogels as nucleus pulposus replacements: Assessment of in vitro structural stability, ex vivo herniation risk, and in vivo biocompatibility
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Steven Nicoll其他文献

Steven Nicoll的其他文献

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{{ truncateString('Steven Nicoll', 18)}}的其他基金

Collaborative Research: GCR: Infection-Resisting Resorbable Scaffolds for Engineering Human Tissue
合作研究:GCR:用于工程人体组织的抗感染可吸收支架
  • 批准号:
    2219025
  • 财政年份:
    2022
  • 资助金额:
    $ 20万
  • 项目类别:
    Continuing Grant
PFI-TT: Injectable Cellulose-Based Hydrogels for Soft Tissue Bulking
PFI-TT:用于软组织膨胀的可注射纤维素水凝胶
  • 批准号:
    2214012
  • 财政年份:
    2022
  • 资助金额:
    $ 20万
  • 项目类别:
    Standard Grant
I-Corps: Injectable Cellulosic Hydrogels for Intervertebral Disc Repair
I-Corps:用于椎间盘修复的可注射纤维素水凝胶
  • 批准号:
    1550024
  • 财政年份:
    2015
  • 资助金额:
    $ 20万
  • 项目类别:
    Standard Grant
CAREER: Polysaccharide-Based Biohybrid Constructs for Engineering of Cartilaginous Tissue
职业:用于软骨组织工程的基于多糖的生物杂交结构
  • 批准号:
    0747968
  • 财政年份:
    2008
  • 资助金额:
    $ 20万
  • 项目类别:
    Standard Grant

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湍流和化学交互作用对H2-Air-H2O微混燃烧中NO生成的影响研究
  • 批准号:
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PFI-AIR-TT: Wearable sleepwear for quantitative prognostication and noninvasive therapy of obstructive sleep apnea
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