Blood Filtration System for the Treatment of Severe Malaria Patients

用于治疗重症疟疾患者的血液过滤系统

• 批准号: 8532028
• 负责人: JAMES F. ANTAKI
• 金额: $ 16.88万
• 依托单位: ACCEL DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2014-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8532028
• 关键词: Address; Adult; Africa South of the Sahara; Animal Testing; Antimalarials; Area; Artemisinins; Biomedical Engineering; Blood; Blood Circulation; Blood Component Removal; Blood Transfusion; Blood Volume; Blood donor; Blood flow; Cambodia; Cause of Death; Cells; Cessation of life; Child; Childhood; Clinical; Combined Modality Therapy; Computer Simulation; Consumption; Coupled; Developed Countries; Development; Devices; Disease; Doctor of Philosophy; Drug resistance; Engineering; Erythrocytes; Excision; Filtration; Generations; Goals; Health Services Accessibility; Health system; Hematocrit procedure; Hemorheology; Hospitalization; Hour; In Vitro; Intravenous; Lead; Legal patent; Letters; Life; Liquid substance; Magnetism; Malaria; Measures; Medical; Medical Device; Medicine; Morbidity - disease rate; Motivation; Parasitemia; Parasites; Parasitic infection; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physics; Pilot Projects; Plasmodium falciparum; Principal Investigator; Process; Property; Quinine; Residual state; Risk; Small Business Innovation Research Grant; Staging; System; Techniques; Technology; Thrombus; Time; Transfection; Transfusion; Translating; Trauma; Treatment Cost; Tropical Disease; United States National Institutes of Health; Universities; Water; Whole Blood Exchange Transfusion; Work; World Health Organization; analog; artemisinine; artesunate; base; blood filtration; blood treatment; commercialization; conventional therapy; cost; design; fetal; in vivo; innovative technologies; mortality; multidisciplinary; novel; operation; pre-clinical; prototype; research clinical testing; research study; scale up; simulation; success; theories; trafficking; wasting

Project Summary: The overall goal of the proposed project is to develop a novel blood filtration system, mPharesis", for the treatment of severe malaria patients. The World Health Organization estimates that each year approximately 300 million malaria episodes occur globally resulting in nearly one million deaths, 85% of which are children. The majority of deaths are caused by severe malaria. Severe malaria is a leading cause of pediatric morbidity, hospitalization, and mortality in Sub-Saharan Africa. It is responsible for more than 200,000 cases of fetal loss and more than 10,000 maternal deaths annually. Severe malaria also occurs in 5% of the nearly 30,000 imported malaria cases by travelers from endemic areas. Even when managed aggressively with intravenous antimalarial drugs (artesunate or quinine) mortality rates range between 10%-22%, and as high as 40% for the most complicated cases. Blood exchange transfusion (ET) and erythropheresis (EP) have been effectively used to significantly accelerate the clearance of malaria infected red blood cells from circulation. A large body of medical studies has shown that these treatments if available are beneficial. However, the current systems used to perform these therapies are not engineered to selectively separate the infected cells from the non infected. Thus, to remove these toxic infected cells the entire patient's blood is disposed - wasting in most cases between to 70%-95% of the healthy blood. This inefficacy results in larger than needed consumption of donor blood. Consequently, ET and EP therapies remain a prerogative of industrialized nations. This is precisely the motivation for developing the proposed mPharesis" system - a system that will allow the removal of toxic infected red blood cells from the patient's blood circulation with minimal or no use of donor blood. The mPharesis" filter operates by targeting these cells' unique (and well-known) magnetic properties. This system represents the first medical device of its kind to employ magnetic separation technology to clear these toxic cells from circulation. In this SBIR Phase 1 effort, we will complete the design verification of a first-generation mPharesis". This objective will be accomplished by entailing experimentation and numerical simulation, to achieve a prototype optimized for high-throughput, high separation efficiency, and low residual parasitic load. In specific, the successful completion of this Phase 1, will yield a working prototype, suitable for animal testing (in Phase 2), capable of reducing parasitic load (up to 40%) to less than 1.0% within a time period of 2-3 hours, and demonstrating satisfactory hemocompatibility. mPharesis" is intended for those millions of children and adults who have already reached the severe malaria stage, and will provide a life-saving measure for cases that do not respond well to conventional treatments - as too often occurs in the advanced severe stages of this deadly disease.

项目概述：本项目的总体目标是开发一种新型血液过滤系统