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（由申请人提供）：该项目评估了由硫酸钙（CS）颗粒物组成的新的多相复合骨修复材料的可行性，该材料可通过可吸收的聚合物覆盖在或内部或内部的CS基质的可吸收聚合物来保护不受其快速降解。骨缺损的修复通常需要使用永久性或可吸收生物材料。这些材料可以包含自源或同种异体骨移植物，这些材料（磷酸钙材料，野生，硫酸钙材料）材料以及这些材料的复合组合。硫酸钙（CS）是用于修复骨缺损的完全降解材料。它是当前使用中最古老，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，破骨电导性，不会引起炎症并唤起最小的外国体内反应。它可以与其他骨移植物材料（例如自体移植物，磷酸钙，野生型和同种异体移植物）结合使用。它具有强大的止血活性，可防止在缺陷区域内的软组织向屏障材料发出。它刺激微血管的生长，因此具有血管生成。它导致磷酸钙沉积物的沉淀在发生溶解时。这些沉淀物刺激并指导新骨的形成。使用CS的从业者的主要关注和投诉是，它（溶解）太快了，在某些应用中超过了新骨的形成。聚（L乳酸），（PLLA）是许多具有出色安全记录的生物医学设备中使用的生物材料。它是生物相容性且可生物降解的。我们以前的研究表明，硫酸钙和PLLA的复合材料在模拟体液中的溶解速度比纯CS慢得多。磷酸钙沉淀物形成，随着该复合材料的降解（这会刺激体内骨的形成）。根据CS：PLLA的比率，可以控制复合材料的降解速率。此处描述的产品代表了可以配制以以受控速率溶解的水泥，该水泥可以与骨修复相匹配，以进行特定的手术应用。该复合材料将克服硫酸钙快速溶解的缺点，但仍将保留其所有独特的特性用于骨移植。有一个现成的市场可以供新材料填充提取地点，增强上颌骨和下颌骨骼以接受牙科植入物，并加快牙科植入物的骨整合性。