Multiphasic Calcium Sulfate Bone Repair Material

多相硫酸钙骨修复材料

• 批准号: 6832895
• 负责人: Harold Alexander
• 金额: $ 10万
• 依托单位: ORTHOGEN, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-08 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6832895
• 关键词: biodegradable product; biomaterial development /preparation; biomaterial evaluation; biomaterial interface interaction; biotechnology; bone disorder; bone regeneration; calcium; cell growth regulation; chemical stability; histology; laboratory rabbit; lactates; morphometry; musculoskeletal disorder therapy; nonhuman therapy evaluation; osteogenesis; polymers; sulfates

DESCRIPTION (provided by applicant): This project evaluates the feasibility of a new multiphasic, composite bone repair material composed of calcium sulfate (CS) particulate, protected from rapid degradation by an absorbable polymer either coated on, or within, a CS matrix. Repair of bone defects often requires the use of permanent or resorbable biomaterials. These materials can comprise autogenous or allogeneic bone graft, a range of alloplastic (calcium phosphate materials, bioglass, calcium sulfate materials) materials and composite combinations of these materials. Calcium sulfate (CS) is a fully degradable material for repair of bone defects. It is one of the oldest and safest biomaterials in current use. Recent research has shown that it is biocompatible, completely degradable, osteoconductive, does not cause inflammation and evokes minimal foreign body response. It can be used in combination with other bone graft materials such as autograft, calcium phosphate, bioglass and allografts. It has strong hemostatic activity and it prevents the ingrowth of soft tissue in the defect area acting as a barrier material. It stimulates the growth of micro blood vessels and hence is angiogenic. It causes precipitation of calcium phosphate deposits as it undergoes dissolution. These precipitates stimulate and direct the formation of new bone. The principal concern and complaint by practitioners using CS is that it (dissolves) too rapidly and outpaces the formation of new bone in some applications. Poly (L Lactic acid), (PLLA) is another biomaterial used in many biomedical devices with an excellent safety record. It is biocompatible and biodegradable. Our previous studies have shown that a composite of calcium sulfate and PLLA undergoes much slower dissolution in simulated body fluid than pure CS. Calcium phosphate precipitate formed as this composite degraded (which would stimulate the formation of bone in vivo). Depending upon the ratio of CS:PLLA, the degradation rate of the composite can be controlled. The product described here represents a cement that can be formulated to dissolve at controlled rates that can be matched with bone repair for a specific surgical application. This composite would overcome the disadvantage of fast dissolution of calcium sulfate, but would still retain all of its unique properties for bone grafting. There is a ready market for a new material to fill extraction sites, enhance maxilla and mandibular bone to accept dental implants, and to speed up the osseointegration of dental implants.

描述(申请人提供)：该项目评估了一种新的多相复合骨修复材料的可行性，该材料由硫酸钙(CS)颗粒组成，通过覆盖在CS基质上或在CS基质内的可吸收聚合物来保护其免受快速降解。骨缺损的修复通常需要使用永久性或可吸收的生物材料。这些材料可以包括自体或同种异体骨移植、一系列同种异体(磷酸钙材料、生物玻璃、硫酸钙材料)材料以及这些材料的复合组合。硫酸钙(CS)是一种完全可降解的骨缺损修复材料。它是目前使用的最古老和最安全的生物材料之一。最近的研究表明，它具有生物相容性、完全可降解、骨传导、不会引起炎症和最小的异物反应。可与自体移植、磷酸钙、生物玻璃、同种异体移植等骨移植材料联合使用。它具有很强的止血活性，并防止软组织在缺损区内生长，起到屏障材料的作用。它刺激微血管的生长，因此是血管生成的。当钙磷酸盐沉淀物经历溶解时，它会引起沉淀。这些沉淀物刺激和引导新骨的形成。使用CS的从业者主要担心和抱怨的是，它溶解太快，在某些应用中超过了新骨的形成。聚L乳酸(PLLA)是另一种用于许多生物医疗设备的生物材料，具有良好的安全记录。它具有生物相容性和可生物降解性。我们之前的研究表明，与纯CS相比，硫酸钙和PLLA的复合材料在模拟体液中的溶解速度要慢得多。当这种复合材料降解时，会形成磷酸钙沉淀(这将刺激体内骨的形成)。根据CS/PLLA的比例，可以控制复合材料的降解速度。这里描述的产品代表了一种骨水泥，它可以配制成以受控的速度溶解，可以匹配特定外科应用的骨修复。这种复合材料将克服硫酸钙快速溶解的缺点，但仍将保留其用于骨移植的所有独特性能。一种新的材料可以填充拔牙部位，增强上颌骨和下颌骨以接受牙种植体，并加速牙种植体的骨整合，市场已经准备就绪。