OMMAYA ARTIFICIAL ORGAN FOR ISLET TRANSPLANTATION

描述(改编自申请人的摘要)：调查员的目标是 完成人工胰腺的临床前开发和测试 脑脊液驱动器官置入脑脊液分流非胰岛素 依赖糖尿病的恒河猴。要证明的兼容性 异种胰岛细胞存活并在脑脊液中产生胰岛素 血糖水平。脑脊液中药物的药代动力学研究 猴子通过Ommaya脑脊液储存库的情况与人类脑脊液的情况相当。 研究人员将评估异种病毒对宿主的长期致敏作用 用细胞和激素免疫反应测量胰岛细胞 一年。目标是获得FDA的批准，以便提供这种方法 对已行CFS分流术的合并脑积水的IDDM患者 现在时。也可用于脆性IDDM患者，如果糖尿病患者有脑积水 治疗是成功的，目前风险很低。 建议的商业应用：不可用

DESCRIPTION (Adapted from applicant's abstract): The investigator aims to complete the pre-clinical development and testing of an artificial pancreatic organ driven by cerebral spinal fluid by placing in CSF shunted in non-insulin dependent diabetic rhesus monkeys. To demonstrate the compatibility of xenogeneic islet cells to survive and to produce insulin in response to CSF glucose levels. The pharmacokinetics of substances placed into the CSF of monkeys via the Ommaya CSF reservoirs are comparable to those of human CSF. The investigators will evaluate long term host sensitization by xenogeneic islet cells using measurements of cellular and hormonal immune response for one year. The goal is to obtain FDA approval in order to offer this approach to IDDM patients with co-existing hydrocephalus in whom CFS shunts are already present. May also be available to brittle IDDM patients if diabetic hydrocephalic patients treatment are successful and currently low risk. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE