NSF/FDA SIR: Fabrication and Evaluation of Bioactive and Biodegradable 3D Printed Polymer Scaffolds

NSF/FDA SIR：生物活性和可生物降解的 3D 打印聚合物支架的制造和评估

• 批准号: 1542065
• 负责人: Abraham Joy
• 金额: $ 10万
• 依托单位: University of Akron
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1542065&HistoricalAwards=false
• 关键词: NSF; FDA; SIR; Fabrication; Evaluation

Non-technical Abstract: This NSF/FDA Scholar-in-Residence program award by the Biomaterials Program in the Division of Materials Research to University of Akron is aimed towards the optimization of a set of polymeric substrates that will be encapsulated with therapeutics. This project will examine how the incorporation of therapeutics within the 3D printing materials will affect their printing process and the printed structures. 3D printing has caught the imagination of scientists and non-scientists alike. It is now conceivable that future manufacturing protocols will include 3D printing as a method to manufacture engineering and medical products. The power of 3D printing becomes all the more relevant for medical products, where it may be possible to create personalized synthetic 'organs' to replace damaged or diseased organs. Such devices may also be used to deliver therapeutics at personalized dosages. However to facilitate the translation of such 3D printed devices to the clinic, several aspects need to be addressed. In addition, these studies will also examine the degradation of these polymeric structures and the rates at which the therapeutic is released. These studies will be carried out at FDA using standardized protocols that will be relevant for future FDA regulatory examinations of 3D printed scaffolds. In addition, the award will provide training opportunities to graduate students and will prepare them for careers in engineering and science. The award will also expose undergraduate and high school students to the field of 3D printing. Technical Abstract: 3D printing is rapidly emerging as an efficient method for the fabrication of personalized medical scaffolds. 3D printing medical devices addresses several desired implant features such as the need to print irregular feature shapes and sizes and the need for implant porosity and the ability to incorporate or encapsulate bioactive molecules. A critical need in this area is for polymeric materials having the right set of properties that enable their printing and integration into the physiological environment. In addition, to enable optimal integration of synthetic materials in a biological environment, it is often necessary to encapsulate them with bioactive molecules. Upon printing they will be cross-linked to 'fix' the printed scaffolds. Such viscoelastic polyesters will be encapsulated with dexamethasone, an anti-inflammatory corticosteroid. Alternatively, the polyesters will be encapsulated with bone morphogenetic proteins. Earlier studies have demonstrated clinical relevance of these therapeutics. This award will examine the effect of such therapeutics on the printing process and on the printed structures, the reproducibility, biocompatibility and biodegradation of the printed structures. In addition, this study will also examine the release profile of the encapsulated bioactive materials. The methodologies adopted for the evaluation of these scaffolds will be carried out in collaboration with the FDA, and these studies are expected to help FDA in establishing protocols for analysis and evaluation of 3D printed scaffolds in general.

非技术摘要：由阿克伦大学材料研究部生物材料项目颁发的 NSF/FDA 常驻学者项目奖旨在优化一组将用治疗药物封装的聚合物基质。该项目将研究 3D 打印材料中的疗法的结合将如何影响其打印过程和打印结构。 3D 打印激发了科学家和非科学家的想象力。现在可以想象，未来的制造协议将包括 3D 打印作为制造工程和医疗产品的方法。 3D 打印的力量对于医疗产品变得更加重要，因为它可以创建个性化的合成“器官”来替代受损或患病的器官。此类装置还可用于以个性化剂量递送治疗剂。然而，为了促进此类 3D 打印设备应用于临床，需要解决几个方面的问题。此外，这些研究还将检查这些聚合物结构的降解以及治疗剂的释放速率。这些研究将在 FDA 使用标准化协议进行，该协议将与 FDA 未来对 3D 打印支架的监管检查相关。此外，该奖项还将为研究生提供培训机会，并为他们在工程和科学领域的职业生涯做好准备。该奖项还将让本科生和高中生接触 3D 打印领域。技术摘要：3D 打印正在迅速崛起，成为制造个性化医疗支架的有效方法。 3D 打印医疗设备可满足多种所需的植入物特征，例如打印不规则特征形状和尺寸的需要、植入物孔隙度的需要以及掺入或封装生物活性分子的能力。该领域的一个关键需求是聚合物材料具有正确的性能，使其能够打印并集成到生理环境中。此外，为了实现合成材料在生物环境中的最佳整合，通常需要用生物活性分子封装它们。打印后，它们将被交联以“固定”打印的支架。这种粘弹性聚酯将被地塞米松（一种抗炎皮质类固醇）封装。或者，聚酯将被骨形态发生蛋白封装。早期的研究已经证明了这些疗法的临床相关性。该奖项将研究此类疗法对印刷过程和印刷结构的影响，以及印刷结构的再现性、生物相容性和生物降解性。此外，本研究还将检查封装的生物活性材料的释放曲线。用于评估这些支架的方法将与 FDA 合作进行，这些研究预计将帮助 FDA 建立 3D 打印支架的总体分析和评估方案。