Calcium Sulfate Based Bioactive Bone Graft

硫酸钙基生物活性骨移植物

• 批准号: 7830703
• 负责人: Harold Alexander
• 金额: $ 19.23万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7830703
• 关键词: Adverse effects; Allografting; Animal Model; Autologous Transplantation; Becaplermin; Benign; Biocompatible; Bioglass; Blood Vessels; Bone Growth; Bone Morphogenetic Proteins; Bone Regeneration; Bone Transplantation; Calcium Sulfate; Carbonates; Cell Culture Techniques; Cells; Chemical Structure; Collagen; Defect; Dental; Dental Implants; Dentistry; Dentists; Development; Effectiveness; Excision; FDA approved; Face; Feasibility Studies; Filler; Fracture; Grant; Growth Factor; Harvest; Hemostatic Agents; Human; In Vitro; Jaw; Kinetics; Maintenance; Malignant Neoplasms; Marketing; Marrow; Mesenchymal; Non-Steroidal Anti-Inflammatory Agents; Organ Transplantation; Orthopedics; Osteogenesis; Patients; Periodontal Pocket; Phase; Phase I Clinical Trials; Platelet-Derived Growth Factor; Polymers; Process; Property; Recombinants; Recording of previous events; Research; Safety; Sinus; Site; Small Business Innovation Research Grant; Stem cells; Tissues; Tooth Loss; Transplanted tissue; Work; allogenic bone transplantation; base; biocompatible polymer; biomaterial compatibility; bone; bone growth factor; bone morphogenetic protein 7; calcium phosphate; improved; in vivo; interest; maxillofacial; new growth; procollagen C-endopeptidase; public health relevance; recombinant human bone morphogenetic protein-2; response; tricalcium phosphate; vasculogenesis

DESCRIPTION (provided by applicant): The aim of this research is to develop an improved, synthetic bone graft material for use in dentistry. The loss of teeth is often accompanied by the loss of jaw bone. Restoring this lost bone is often a prerequisite for the installation of dental implants and the maintenance of normal facial features. Calcium sulfate works quite well as a bone regeneration material. It serves not only as a defect filler, but is also biocompatible, conducts new bone growth and encourages the growth of new blood vessels. However, its fast degradation is its major shortcoming, restricting its use in bone grafting applications. Based upon a successful phase I feasibility study, this project proposes the development of a new material: a calcium sulfate/absorbable polymer composite with superior biocompatibility and bone-compatibility and bone growth factor delivery capability. Phase I studies have already demonstrated that calcium sulfate/ absorbable polymer composites undergo slower degradation than pure calcium sulfate and thus overcomes a significant drawback of this material as a bone regeneration product. The plan now is to develop a product that dentists can use in bone grafting procedures that will rival the bone regeneration potential seen with the use of the patients' own harvested bone. The product, a composite of calcium sulfate and Poly DTE carbonate that delivers a bone growth factor, rhBMP-2, utilizes a new polymer whose in vivo bone response has been studied in several animal models. Because of its specific chemical structure, this polymer elicits an excellent cell and tissue response. Since an earlier version of this product has already been commercialized, this new product will be rapidly introduced to the marketplace as an improved replacement. PUBLIC HEALTH RELEVANCE: Bone grafting is an essential component of facial and dental maintenance. Recent concern about allograft bone supply makes the development of a reliable, affordable synthetic essential to this process. This project describes the development of just such a synthetic with bone regeneration capability rivaling autografts based on a simple, affordable material with a long safety history, calcium sulfate, combined with a new highly bone-compatible and biocompatible polymer and a bone growth factor.

描述（由申请人提供）：本研究的目的是开发一种用于牙科的改进的合成骨移植材料。牙齿的缺失常常伴随着颌骨的缺失。恢复丢失的骨质通常是安装牙种植体和维持正常面部特征的先决条件。硫酸钙作为骨再生材料效果很好。它不仅可以作为缺陷填充剂，而且具有生物相容性，可以促进新骨生长并促进新血管生长。然而，其快速降解是其主要缺点，限制了其在骨移植应用中的使用。基于成功的一期可行性研究，该项目建议开发一种新材料：硫酸钙/可吸收聚合物复合材料，具有优异的生物相容性和骨相容性以及骨生长因子输送能力。第一阶段的研究已经表明，硫酸钙/可吸收聚合物复合材料的降解速度比纯硫酸钙慢，从而克服了该材料作为骨再生产品的显着缺点。现在的计划是开发一种牙医可以在骨移植手术中使用的产品，该产品将与使用患者自己采集的骨所具有的骨再生潜力相媲美。该产品是硫酸钙和聚 DTE 碳酸盐的复合材料，可提供骨生长因子 rhBMP-2，采用了一种新聚合物，该聚合物的体内骨反应已在多种动物模型中进行了研究。由于其特定的化学结构，这种聚合物能够引发出色的细胞和组织反应。由于该产品的早期版本已经商业化，因此该新产品将作为改进的替代品迅速推向市场。 公众健康相关性：骨移植是面部和牙齿维护的重要组成部分。最近对同种异体移植骨供应的担忧使得开发一种可靠、负担得起的合成材料对于这一过程至关重要。该项目描述了一种具有与自体移植物相媲美的骨再生能力的合成材料的开发，该合成材料基于一种简单、负担得起且安全历史悠久的材料——硫酸钙，并结合了一种新的高度骨相容性和生物相容性聚合物和骨生长因子。