PRIMATE MODEL EVALUATION OF A TISSUE ENGINEERED HEART VALVE

组织工程心脏瓣膜的灵长类动物模型评估

• 批准号: 7957944
• 负责人: Richard A Hopkins
• 金额: $ 1.39万
• 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/7957944
• 关键词: Allografting; Biological; Biology; Cardiovascular system; Cells; Child; Chronic; Clinical; Complex; Computer Retrieval of Information on Scientific Projects Database; Engineering; Evaluation; Excision; Funding; Grant; Heart Valves; Human; Immune; Infant; Inflammatory; Institution; Lung; Mediating; Modeling; Papio; Patients; Performance; Primates; Process; Research; Research Personnel; Research Project Grants; Resources; Safety; Sheep; Source; Structural Protein; Testing; Therapeutic; Tissue Engineering; Translational Research; Transplantation; United States National Institutes of Health; Xenograft procedure; design; immunogenic; in vivo; novel; preclinical safety; response; safety testing; scaffold; semilunar valve; 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. Chronic in vivo studies in sheep may not be sufficient to adequately evaluate primate-specific complex biology, immune and inflammatory-mediated responses that are critical factors expected to significantly impact the safety, performance and therapeutic durability of a tissue engineered biological heart valve for human clinical use. Such a tissue engineered cardiovascular construct, by definition, includes both cells (derived from the patient/recipient), and structural proteins (derived from the donor heart valve). The putative prototypical tissue engineered pulmonary valved conduit scaffold to be tested consists of either an allograft (homograft; ie, baboon species for orthotopic transplant) or a xenograft (human semilunar valve) scaffold. Both test valve types will have been engineered to effect removal of donor cells and reduce antigenicity (using our novel decellularization process). This design will test the safety of the acellular construct and the immunogenic and proinflammatory potential of allograft (papio) versus xenograft (human) structural proteins.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这一转化性研究项目是由于需要开发新的评估工具来评估用于婴儿、儿童和年轻人的组织工程生物心脏瓣膜的临床前安全性。绵羊的慢性体内研究可能不足以充分评估灵长类动物特有的复杂生物学、免疫和炎症介导的反应，这些都是预计将显著影响人类临床使用的组织工程生物心脏瓣膜的安全性、性能和治疗持久性的关键因素。根据定义，这种组织工程心血管结构既包括细胞(来自患者/接受者)，也包括结构蛋白(来自供者心脏瓣膜)。待测试的典型组织工程带瓣肺管道支架由同种异体移植(同种移植；即用于原位移植的狒狒)或异种移植(人类半月瓣)支架组成。这两种类型的测试阀都将被设计成能够去除供体细胞并降低抗原性(使用我们新的脱细胞工艺)。这项设计将测试去细胞构建的安全性，以及同种异体移植物(PAPIO)与异种移植物(人)结构蛋白的免疫原性和促炎潜能。