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: 6381166
• 负责人: TERRY M SCHAACK
• 金额: $ 39.98万
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6381166
• 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：（改编自申请人摘要）肾移植残留 上级于慢性肾透析。器官可用性是最大的障碍， 每年有成千上万的人进行移植。一种能安全移除 抗-A和抗-B抗体可通过以下方式显著增加器官可用性： 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。调查人员已经证明， 去除抗A和抗B抗体的原型装置的可行性 在第一阶段试验中从人血中提取的。该装置简单， 生物相容性，并产生可重复的结果。第二阶段研究是 设计用于生产去除体内抗A和抗B抗体的装置 其安全性与常规装置相似。 与McGowan人工器官中心的成功合作 匹兹堡大学医学中心的发展有助于 该项目第一阶段的顺利完成。这一协作努力 将在第二阶段扩大。其他合作， 成功完成这个项目的关键是与弯曲研究 Inc.（膜和高级分离科学）和Source Pharmaceuticals （血型抗原的合成）。 拟议商业应用：不可用