An Intravascular Bioartificial Pancreas (iBAP)

 描述（由申请人提供）：大约300万美国人和全球约2400万人受1型糖尿病（T1D）影响。葡萄糖监测后进行外源性胰岛素注射、同种异体全器官胰腺移植和同种异体胰岛移植是T1D最常见的治疗方法。这些治疗对许多患者实现了血糖控制，但导致严重的并发症。一种生物人工胰腺， 这是一种很有前途的T1D治疗方法，因为它含有功能性胰岛。不幸的是，之前对BAP开发的尝试因胰岛室内质量转移不足而受到严重限制。硅肾的创始人开发了硅纳米孔膜（SNM），实现高效血液超滤，同时选择性保留特定溶质 生物人工肾项目，该项目的成功可直接转移到 iBAP。SNM的超高水力渗透特性将使得能够在胰岛室内进行适当的质量输送（特别是氧气、葡萄糖和胰岛素），以实现最佳的胰岛性能，而SNM的超选择性特性使得能够进行前所未有的免疫隔离。iBAP将连接在动脉和静脉移植物之间，胰岛室的压降将在胰岛室内产生超滤液流。超滤液将提供营养物质（特别是氧气和葡萄糖）到胰岛室和胰岛素到血液通道的对流质量运输。本项目的长期目标是建立血管内生物人工胰腺（iBAP），以实现1型糖尿病（T1D）的外源性胰岛素非依赖性血糖控制。该I期SBIR项目将通过证明体外适当的胰岛室性能和体内iBAP血液相容性来证明iBAP的可行性。

 DESCRIPTION (provided by applicant): Approximately 3 million Americans and around 24 million people worldwide are affected by Type 1 Diabetes (T1D). Glucose monitoring followed by exogenous insulin injection, allogeneic whole organ pancreas transplantation, and allogeneic islet transplantation are the most common treatments for T1D. These treatments have achieved glycemic control for many patients but result in serious complications. A bioartificial pancreas is a promising treatment for T1D because it contains functional islets. Unfortunately previous attempts at BAP development have been severely limited by insufficient mass transfer within the islet chamber. The founders of Silicon Kidney have developed silicon nanopore membranes (SNM) to achieve high-efficiency blood ultrafiltration while selectively retaining specific solutes for the Bioartificial Kidney Project and this project's successes are directly transferrable to the iBAP. The ultra-high-hydraulic-permeable characteristic of the SNM will enable appropriate mass transport (especially oxygen, glucose, and insulin) within the islet chamber to achieve optimal islet performance, while the ultra-selective characteristic of the SNM enable unprecedented immunoisolation. The iBAP will be connected between an arterial and venous graft and a pressure drop across the Islet Chamber will produce an ultrafiltrate flow within the Islet Chamber. The ultrafiltrate will provide convective mass transport of nutrients (especially oxygen and glucose) to the Islet Chamber and insulin to the blood channels. The long-term objective of our project is to create the intravascular Bioartificial Pancreas (iBAP) to achieve exogenous insulin independent glycemic control of Type 1 Diabetes (T1D). This Phase I SBIR project will prove the feasibility of the iBAP by demonstrating proper Islet Chamber performance in vitro and iBAP hemocompatibility in vivo.