BLOOD FILTRATION SYSTEM FOR THE TREATMENT OF SEVERE MALARIA PATIENTS -
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.