ECM Bioscaffold for ASD Repair

用于 ASD 修复的 ECM 生物支架

• 批准号: 7054440
• 负责人: Abby Simmons-Byrd
• 金额: $ 10.3万
• 依托单位: ACELL, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7054440
• 关键词: bioengineering /biomedical engineering; biomaterial development /preparation; biomaterial evaluation; biomechanics; biomedical equipment development; biophysics; biotechnology; congenital heart septum defect; extracellular matrix; implant; medical implant science; swine; tissue support frame

DESCRIPTION (provided by applicant): This Phase I proposal seeks support to evaluate the feasibility of developing an extracellular matrix (ECM) biologic scaffold as a repair device for atrial septal defects (ASD). ASDs are one of the most common forms of congenital heart disease and account for approximately 30-40% of all congenital heart defects seen in adults. Closure of an ASD can be performed either surgically or percutaneously, and the success rate of this procedure is very high. However, recent reports suggest that complications with severe hemodynamic consequences do occur and are a result of the metal cage configuration of the repair device. This cage configuration serves as an abrasive surface to adjacent atrial roof and aortic tissues. The proposed studies would utilize non-abrasive, naturally occurring ECM configured in mechanically-appropriate, multilaminate form as the repair device. This Phase I proposal has three Specific Aims. The first Specific Aim would develop a prototype ECM device suitable for percutaneous delivery. The second Specific Aim would evaluate the biomechanical and biophysical properties of the device. The final Specific Aim would determine functionality in a pig model of surgically created ASD. These studies will be conducted by an experienced team of investigators at ACell, Inc., with a subcontract for the animal studies at the Center for Preclinical Studies within the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Clearly defined criteria for success are identified for each Specific Aim and a timeline for completion of the studies is provided.

描述（由申请人提供）：本I阶段提案寻求支持以评估开发细胞外基质（ECM）生物学支架作为心房间隔缺陷（ASD）的维修装置的可行性。 ASD是先天性心脏病的最常见形式之一，约占成人所有先天性心脏缺陷的30-40％。 ASD的闭合可以手术或经习惯进行，并且此过程的成功率很高。但是，最近的报道表明，确实会发生严重的血液动力学后果并发症，这是维修装置的金属笼构型的结果。这种笼子构型充当邻近心房屋顶和主动脉组织的磨料表面。拟议的研究将利用以机械适合的多层压形式配置为维修装置的非植物自然发生的ECM。该阶段的提案具有三个具体目标。第一个特定目标将开发出适合经皮递送的原型ECM设备。第二个特定目的将评估设备的生物力学和生物物理特性。最终的特定目的将确定手术创建的ASD的猪模型中的功能。这些研究将由Acell，Inc。的经验丰富的研究人员团队进行，并在匹兹堡大学麦高万再生医学研究所的临床前研究中心进行分包合同。为每个特定目标确定了明确定义的成功标准，并提供了完成研究的时间表。