MEDICAL DEVICE TO REMOVE ANTI-A AND ANTI-B ANTIBODIES

去除抗 A 和抗 B 抗体的医疗器械

• 批准号: 6144507
• 负责人: TERRY M SCHAACK
• 金额: $ 34.78万
• 依托单位: ADVANCED EXTRAVASCULAR SYSTEMS
• 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 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6144507
• 关键词: biomedical equipment development; blood chemistry; blood group antigens; blood treatment; clinical biomedical equipment; clinical research; hollow fiber separation technique; human subject; isoantibody; kidney transplantation

DESCRIPTION: (Adapted from applicant's abstract) Renal transplant remains superior to chronic renal dialysis. Organ availability is the largest hurdle to transplant for thousands of individuals per year. A device which safely removes anti-A and anti-B antibodies may significantly increase organ availability by reducing or eliminating ABO matching requirements. There are no FDA-approved devices which achieve this goal. The investigator has demonstrated the feasibility of a prototype device which removes anti-A and anti-B antibodies from whole human blood during a Phase I trial. The device is simple, biocompatible, and generates reproducible results. This Phase II research is designed to produce a device to remove anti-A and anti-B antibodies in vivo with the safety profile acceptably similar to routine devices. A successful collaboration with the McGowan Center for Artificial Organ Development at the University of Pittsburgh Medical Center was instrumental in the successful completion of Phase I of this project. This collaborative effort will be expanded during the proposed Phase II. Additional collaborations, crucial to the successful completion of this project, are with Bend Research Inc. (membrane and advance separations sciences), and Source Pharmaceuticals (synthesis of blood group antigens). PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述：（改编自申请人的摘要）肾移植遗骸 优于慢性肾透析。器官供应是最大的障碍 每年为数千人进行移植。一种可以安全移除的装置 抗 A 和抗 B 抗体可显着提高器官可用性 减少或消除 ABO 匹配要求。没有 FDA 批准的 实现这一目标的设备。研究人员已经证明 去除抗 A 和抗 B 抗体的原型装置的可行性 在第一阶段试验期间从全人类血液中提取。该装置结构简单， 生物相容性，并产生可重复的结果。这项二期研究是 设计用于生产去除体内抗 A 和抗 B 抗体的装置 其安全性与常规设备相似，可以接受。 与麦高恩人工器官中心的成功合作 匹兹堡大学医学中心的发展发挥了重要作用 该项目一期工程顺利竣工。此次合作的努力 将在拟议的第二阶段期间扩大。额外的合作， Bend Research 对该项目的成功完成至关重要 Inc.（膜和先进分离科学）和 Source Pharmaceuticals （血型抗原的合成）。 拟议的商业应用：不可用