Biodegradable Bone Graft Extender

描述（来自申请人的逐字记录）：为了扩展临床实用性 骨替代材料，我们建议开发一种可生物降解的骨 具有诱导能力的接枝延伸剂。诱导性生物可降解增量剂将 在自体移植物是优选的情况下是有用的，但患者自己 骨储备不足。SBIR第一阶段项目将确定 延长剂促进骨组织再生的可行性 由生物聚合物聚（丙二醇-共-富马酸）（PPF）制成。 这种不饱和聚合物可以在交联剂存在下交联， 形成骨传导网络的试剂， 在缺损填充之前进行自体移植。在第一阶段，我们将寻求发展 聚合物/骨组合，证明体外和体内耐久性超过 时间，同时支持与传统自体骨等同的骨形成 嫁接第二阶段将致力于研究目标， 解决了自体骨移植被认为是 更可取的“黄金标准”，但可能无法提供足够的 是介于这种复合材料可能具有上级的生物学特性 皮质松质骨同种异体骨芯片常规用于这一点， 形势骨诱导自体移植材料与高度 具有骨传导性但可吸收的支架对两者都有吸引力 诱导和扩展新骨形成。 拟定商业应用： 每年有超过425，000例肌肉骨骼手术使用骨移植。 总体而言，80%的 骨移植物用于矫形外科和脊柱外科。 自体移植是首选 移植材料，但有时病人自己的骨量不足。 据估计 合成骨替代材料仅用于25，000 - 35，000例临床移植， 因为它们主要是骨传导性的。 如果自体移植可以 通过可吸收的骨传导材料容易地延伸，市场接受将随之而来。

DESCRIPTION (Verbatim From Applicant): In order to expand the clinical utility of bone replacement materials, we are proposing to develop a biodegradable bone graft extender with inductive capacity. Inductive biodegradable extenders would be useful in situations where autografts are preferable, yet the patients own bone stocks are insufficient. This SBIR Phase I project will determine the feasibility of enhancing the regeneration of skeletal tissues with an extender fashioned from the biopolymer poly(propylene glycol-co-fumaric acid) (PPF). This unsaturated polymer can be crosslinked in the presence of effervescent agents to create an osteoconductive network that can be immediately mixed with autograft prior to defect filling. In Phase I we will seek to develop polymer/bone combinations that demonstrate in vitro and in vivo durability over time, while supporting bone formation equivalent to traditional autologous bone grafting. Phase II would then address research objectives directed towards resolution of the clinical dilemma where autologous bone graft is recognized as the preferable "gold standard," but may not be available in sufficient quantities. This composite could have biological properties that are superior to the cortico-cancellous allogeneic bone chips routinely used in this situation. Osteoinductive autograft material used in conjunction with a highly osteoconductive, yet resorbable, scaffold would be attractive for both induction and expansion of new bone formation. PROPOSED COMMERCIAL APPLICATION: Bone grafts are used in over 425,000 musculoskeletal operations annually. Overall, 80% of the bone grafts are used in orthopaedic and spine surgery. Autografts are the preferred grafting material, but sometimes the patient's own bone stocks are deficient. It is estimated that synthetic bone replacement materials are used in only 25,000 - 35,000 of clinical grafting procedures because they are primarily only osteoconductive. If autogenous grafts could be easily extended via a resorbable osteoconductive material, market acceptance would follow.