The overall goal of the proposed project is to develop a novel blood filtrationsystem, mPharesis', for the treatment of severe malaria patients. The World Health Organizationestimates that each year approximately 300 million malaria episodes occur globally resulting in nearlyone 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-SaharanAfrica. It is responsible for more than 200,000 cases of fetal loss and more than 10,000 maternaldeaths annually. Severe malaria also occurs in 5% of the nearly 30,000 imported malaria cases bytravelers 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 mostcomplicated cases. Blood exchange transfusion (ET) and erythropheresis (EP) have been effectivelyused to significantly accelerate the clearance of malaria infected red blood cells from circulation. Alarge body of medical studies has shown that these treatments if available are beneficial. However, thecurrent systems used to perform these therapies are not engineered to selectively separate the infectedcells from the non infected. Thus, to remove these toxic infected cells the entire patient's blood isdisposed - wasting in most cases between to 70%-95% of the healthy blood. This inefficacy results inlarger than needed consumption of donor blood. Consequently, ET and EP therapies remain aprerogative of industrialized nations. This is precisely the motivation for developing the proposedmPharesis' system - a system that will allow the removal of toxic infected red blood cells from thepatient's blood circulation with minimal or no use of donor blood. The mPharesis' filter operates bytargeting these cells' unique (and well-known) magnetic properties. This system represents the firstmedical device of its kind to employ magnetic separation technology to clear these toxic cells fromcirculation. In this SBIR Phase 1 effort, we will complete the design verification of a first-generationmPharesis'. This objective will be accomplished by entailing experimentation and numericalsimulation, to achieve a prototype optimized for high-throughput, high separation efficiency, and lowresidual parasitic load. In specific, the successful completion of this Phase 1, will yield a workingprototype, suitable for animal testing (in Phase 2), capable of reducing parasitic load (up to 40%) to lessthan 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 severemalaria stage, and will provide a life-saving measure for cases that do not respond well to conventionaltreatments - as too often occurs in the advanced severe stages of this deadly disease.

Public Health Relevance

(NIH SBIR Phase-I, December 5th 2011 Application) Application Title: Blood Filtration System for the Treatment of Severe Malaria Patients Tropical Health Systems, LLC Contact PI: Alberto Gandini, Ph.D., MBA Consortium PI: James Antaki, Ph.D. Tropical Health Systems is developing a novel blood filtration system, mPharesis, for the treatment of severe malaria. Severe malaria is a life-threatening condition causing the vast majority of the nearly one million malaria fatalities each year. mPharesis technology would allow the removal of malaria infected red blood cells from the patient's blood safely, effectively, and swiftly. mPharesis will significantly reduce the consumption of donor blood by up to 95% compared to current blood treatment technologies, thus reducing the treatment cost and increasing access to treatment to millions of people.!mPharesis will provide a life-saving treatment to those millions of children and adults who have reached the severe malaria stage, and do not respond well to conventional treatment - as too often occurs with this deadly disease.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-VH-F (10))
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Mitchell, Phyllis
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Accel Diagnostics
United States
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