ISLET GRAFTS IN SERTOLI CELL IMMUNOPRIVILEGED SITES

I型糖尿病及其并发症是健康的巨大代价 护理系统。实施胰岛移植使患者能够 重新获得对血糖水平的生理控制面临两个问题 主要障碍：缺乏人类供体胰腺和移植排斥反应。使用 动物细胞或组织和免疫抑制可以改善这些 问题，但会带来额外的问题，特别是慢性问题 服用有毒的免疫抑制剂。Sertoli Technologies 公司正在开发一种糖尿病细胞疗法和产品，其基础是 支持细胞和胰岛异种移植，提供有限和局部的， 不是全身的，免疫抑制和促进移植组织的生长。 建议的发展计划有系统地建立在我们初步经验的基础上。 用我们选择的Sertoli细胞和胰岛来源，建立质量 细胞的标准，证明了该疗法在 化学诱导和自身免疫的糖尿病啮齿动物，探索 免疫抑制的选择、移植部位及其影响 并估计细胞的剂量-反应关系。这些 数据将确立我们的商业产品，满足监管部门的担忧 并使未来在高等动物中进行的安全性和有效性研究成为可能 I型糖尿病患者开始异种移植的前奏。

Type I diabetes and its complications is a tremendous cost to the health care system. Implementing islet transplantation to enable patients to regain physiological control of their blood glucose levels faces two major obstacles: lack of human donor pancreases and graft rejection. Use of animal cells or tissues and immunosuppression could ameliorate these problems, but introduce additional problems, particularly chronic administration of toxic immunosuppressive agents. Sertoli Technologies, Inc. is developing a diabetes cellular therapy and product based on Sertoli cell and islet xenografts that provides limited and localized, not systemic, immunosuppression and enhanced growth of engrafted tissue. The proposed development systematically builds on our initial experience with our chosen Sertoli cell and islet source, establishes quality criteria for the cells, demonstrates the efficacy of the therapy in chemically-induced and autoimmune diabetic rodents, explores immunosuppression options, transplant sites and the effect of pretolerization and estimates a cell dose-response relationship. These data will establish our commercial product, satisfy regulatory concerns and enable future safety and efficacy studies in higher animals as a prelude to initiation of xenotransplantation in type I diabetic patients.