OPTIMIZATION OF A BIOARTIFICIAL LIVER-PHASE II

生物人工肝相 II 的优化

• 批准号: 6381251
• 负责人: LEONARD P RUIZ
• 金额: $ 40.75万
• 依托单位: ALGENIX, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2002-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6381251
• 关键词: animal tissue; biomedical equipment development; bioreactors; collagen; cryopreservation; liver; liver cells; liver failure; liver transplantation; swine; technology /technique development; temperature; tissue engineering

DESCRIPTION (Adapted from the Investigator's Abstract): Algenix, Inc. is taking a bioartificial liver (BAL) developed at the University of Minnesota through a Phase I clinical trial. This bioartificial liver is intended for providing a temporary support to liver failure patients awaiting transplantation. The BAL employs porcine hepatocytes entrapped in a collagen matrix within the lumens of a hollow-fiber bioreactor. A Phase I Clinical Trial is to be conducted at the University of Minnesota. A continuing major challenge in its development will be to develop an acceptable protocol of "shelf-storage" and to demonstrate the efficacy of such "shelf-stored" BAL in animal trials. In Phase I research the feasibility of using a hypothermic process to extend the life of BAL for shipping has been demonstrated. This proposed research, in its Phase II, will further optimize the hypothermic storage conditions using genomic research techniques, scale up the optimized process and perform animal trials to test the effectiveness of the hypothermically treated bioartificial liver. A successful Phase II research will facilitate the distribution of the bioartificial liver, hasten multi-center clinical trials and advance the application of this technology to treat needed patients. PROPOSED COMMERCIAL APPLICATION: Algenix Inc. plans to introduce the LIVE-Rx 2000 SYSTEM for the fulminant hepatic failure (FHF) indications (liver failure). The Company intends to market and sell machines and single-use treatment kit containing bioreactors, i.e., hemodialyzer cartridges containing hepatocytes embedded in collagen. The Company will initially focus on marketing LIVE-Rx 2000 SYSTEM into liver transplant centers. The initial sales focus for the Company will be the major liver transplant centers in the U.S. These are characteristically very sophisticated, multidiciplinary programs with surgeons, internal medicine, immunologists and other highly trained individuals working together in a tightly coordinated team. They will demand a high level of service, but because of their technical expertise can be expected to quickly master this new technology.

描述（改编自研究者摘要）：Algenix, Inc. 正在采取 明尼苏达大学开发的生物人工肝（BAL） I期临床试验。这种生物人工肝旨在提供 为等待移植的肝衰竭患者提供临时支持。巴尔 使用被包埋在管腔内的胶原基质中的猪肝细胞 中空纤维生物反应器。 I 期临床试验将在 明尼苏达大学。其发展中持续的重大挑战将 制定可接受的“货架储存”协议并证明 这种“储存的”BAL 在动物试验中的功效。在第一阶段研究中 使用低温过程延长 BAL 寿命的可行性 运输已被证明。这项拟议的第二阶段研究将 利用基因组研究进一步优化低温储存条件 技术，扩大优化工艺并进行动物试验来测试 低温处理生物人工肝的有效性。一个 第二阶段研究的成功将促进该药物的分发 生物人工肝加快多中心临床试验推进 应用该技术来治疗需要的患者。 拟议的商业应用： Algenix Inc. 计划推出 LIVE-Rx 2000 系统，用于治疗暴发性肝病 衰竭（FHF）适应症（肝衰竭）。 该公司打算营销和销售机器和 含有生物反应器的一次性治疗套件，即含有肝细胞的血液透析器盒 嵌入胶原蛋白中。 公司最初将专注于将 LIVE-Rx 2000 系统营销到 肝移植中心。 公司最初的销售重点将是美国主要的肝移植中心。 这些项目的特点是非常复杂、涉及外科医生、内科医师的多学科项目。 医学、免疫学家和其他训练有素的人员紧密协调地合作 团队。 他们会要求高水平的服务，但由于他们的技术专长可以 期望能够快速掌握这项新技术。