Biodegradable Bone Graft Extender

可生物降解的骨移植延长器

• 批准号: 6646230
• 负责人: DEBRA J TRANTOLO
• 金额: $ 41.14万
• 依托单位: CAMBRIDGE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6646230
• 关键词: biodegradable product; biomaterial development /preparation; biomaterial evaluation; biomechanics; bone prosthesis; bone regeneration; dicarboxylate; histology; laboratory rat; medical implant science; osteogenesis; polymers; sheep; tissue engineering; tissue support frame

DESCRIPTION (provided by applicant): In order to expand upon the clinical utility of bone replacement materials, Cambridge Scientific, Inc proposes to develop a biodegradable bone graft extender that has the ability to increase the working volume of autograft without compromising its inductive capacity of autograft Biodegradable extenders would be useful in situations in which autografts are preferable, yet the patient's own bone stocks are deficient. This grant application has as its goal the preclinical development of a degradable poly(propylene glycol-co-fumaric acid) ("PPF")-based bone graft extender containing osteoconductive hydroxylapatite fillers that can be mixed with osteoinductive cancellous autologous bone graft prior to implantation into a bony defect. In the Phase I SBIR feasibility project, Cambridge Scientific, Inc demonstrated in a small animal model that the addition of a PPF-based bone replacement material to autograft bone enhances osteointegratior of autograft which, in turn, has an effect on bony ingrowth. Following this demonstration of PPF/autograft enhancement of new bone formation, Cambridge Scientific, Inc will, in Phase II, evaluate the use of the extender material in a large animal (sheep) defect model to address the eventual clinical use of the extender in the reconstruction of significant skeletal defects. The development of new bone should couple to implant degradation in such a way that the structural integrity of the defect site is maintained throughout the recovery process Osteoinductive autograft material used in conjunction with an osteoconductive and mechanically stable resorbable scaffold would be attractive for both induction and expansion of new bone formation.

描述（由申请人提供）：为了扩大骨替代材料的临床应用，剑桥科学公司提议开发一种可生物降解的骨移植延长剂，该延长剂能够增加自体移植物的工作体积而不损害其自体移植物的诱导能力在优选自体移植但患者自身骨量不足的情况下，可生物降解的增量剂将很有用。该拨款申请的目标是临床前开发一种可降解的聚（丙二醇-富马酸）（“PPF”）基骨移植增量剂，其中含有骨传导性羟基磷灰石填充剂，可在植入前与骨诱导性松质自体骨移植物混合变成骨缺损。在第一期 SBIR 可行性项目中，剑桥科学公司在小动物模型中证明，在自体移植骨中添加基于 PPF 的骨替代材料可以增强自体移植物的骨整合，从而对骨向内生长产生影响。在展示 PPF/自体移植物增强新骨形成之后，剑桥科学公司将在第二阶段评估增量剂材料在大型动物（绵羊）缺陷模型中的使用，以解决增量剂在显着骨骼缺损的重建。新骨的发育应与植入物降解相结合，以便在整个恢复过程中保持缺损部位的结构完整性。与骨传导性和机械稳定的可吸收支架结合使用的骨诱导自体移植材料对于诱导和扩张都具有吸引力新骨形成。