OPTIMIZATION OF A BIOARTIFICIAL LIVER

Algenix公司正在使用一种生物人工肝（BAL）， 明尼苏达大学通过I期临床试验。这 生物人工肝旨在为以下患者提供临时支持： 等待移植的肝衰竭患者。 BAL雇用 猪肝细胞包埋在胶原蛋白基质中， 中空纤维生物反应器。 FDA已经批准了一项I期临床试验， 试验将在明尼苏达大学进行。 持续 其发展中的主要挑战将是最大化肝细胞 反应堆中的密度，并制定一个可接受的协议“货架- 存储.“这项拟议的研究，在其第一阶段，将调查 增加细胞装载密度的可行性和 开发一种储存和运输BAL的方法。 期 我只研究了有限数量的变量， 包括胶原细胞浓度、装载和储存 温度 实验变量的影响将是 通过评估以下各项的活力和肝脏比活性进行评价： BAL中的肝细胞。 一个成功的阶段I将导致一个阶段 II.赠款，用于开发改进的 用于进一步大型动物临床前试验的生物人工肝 和临床应用。 拟定商业应用： 肝脏辅助装置预期用于满足以下患者的临床需求： 并为患有急性肝衰竭的患者提供一座“桥梁” 肝脏移植 BAL也可以作为治疗 需要解毒的病人和 否则健康的肝脏就会停止运转

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. The FDA has approved a Phase I Clinical Trial to be conducted at the University of Minnesota. A continuing major challenge in its development will be to maximize hepatocyte density in the reactor and to develop an acceptable protocol of "shelf- storage." This proposed research, in its Phase I, will investigate the feasibility of increasing the cell loading density and the possibility of developing a method of storing and shipping the BAL. In the Phase I research only limited number of variables will be investigated, including collagen cell concentration, and loading and storage temperature. The effects of the experimental variables will be evaluated by assessing the viability and liver specific activities of the hepatocytes in the BAL. A successful Phase I will lead to a Phase II Grant to develop a pilot manufacturing process of the improved bioartificial liver for use in further large animal pre-clinical trials and clinical applications. PROPOSED COMMERCIAL APPLICATION: The liver assist device is intended to address the clinical needs of patients suffering from acute liver failure and to provide a "bridge" to liver transplant. The BAL would also serve as a treatment for patients requiring detoxification and for trauma patients whose otherwise healthy liver has shut down.