BIOENGINEERED HEART VALVES: BABOON IMPLANT FEASIBILITY STUDY

生物工程心脏瓣膜：狒狒植入可行性研究

• 批准号: 7957943
• 负责人: Richard A Hopkins
• 金额: $ 0.82万
• 依托单位: TEXAS BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-06 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7957943
• 关键词: Allografting; Biological; Biomedical Engineering; Bioprosthesis device; Cardiovascular system; Child; Chronic; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Evaluation; Feasibility Studies; Funding; Grant; Heart Valves; Human; Implant; Infant; Institution; Modeling; Operative Surgical Procedures; Papio; Preclinical Testing; Primates; Research; Research Personnel; Research Project Grants; Resources; Source; Structural Protein; Tissue Engineering; Translational Research; United States National Institutes of Health; Xenograft procedure; design; experience; heart valve replacement; immunogenic; preclinical safety; safety testing; scaffold; tool; young adult

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This translational research project is prompted by the need to develop new evaluative tools to assess the preclinical safety of tissue engineered biological heart valves intended for use in infants, children and young adults. This design will test the safety of the acellular construct and the immunogenic and proinflammatory potential of allograft (papio) versus xenograft (human) structural proteins. The initial implants will be constructed as decellularized scaffolds. Development of such a relevant primate model should facilitate the extension to clinical studies for any putative tissue engineered cardiovascular construct. Specific Aim: Explore the feasibility of developing chronic baboon models of open heart valve replacement surgeries for the evaluation of biological heart valve. The utility of conducting such studies in baboons will be determined by comparison to control biological and bioprosthetic (cryopreserved allograft and xenograft bioprosthetic manufactured) valves that already have had extensive preclinical testing and worldwide clinical experience.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项翻译研究项目是由于需要开发新的评估工具来评估旨在用于婴儿，儿童和年轻人的临床前的安全性。 该设计将测试细胞构建体的安全性以及同种异体移植（Papio）与异种移植（人）结构蛋白的免疫原性和促炎潜力。初始植入物将被构造为脱细胞支架。 这种相关的灵长类动物模型的开发应促进任何假定的组织工程心血管结构的临床研究扩展。 具体目的：探索开放心脏瓣膜替换手术的慢性狒狒模型以评估生物心脏瓣膜的可行性。在狒狒中进行此类研究的实用性将通过与对照生物和生物假体（冷冻保存的同种异体移植和异种移植生物假体制造）瓣膜进行比较，这些瓣膜已经具有广泛的临床前测试和全球的临床经验。