San Diego-based Aethlon Medical Inc. announced Friday the Food and Drug Administration has approved a clinical protocol to treat Ebola-infected individuals in the United States with the Aethlon’s Hemopurifier blood filter.
The Hemopurifier is a bio-filtration device designed for the single-use removal of viruses from the circulatory system of infected individuals. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.
The approved Ebola treatment protocol allows for an investigational study to be conducted at up to 10 U.S. locations, and up to 20 U.S. subjects may be enrolled to receive the treatment. Patients will receive a daily six- to eight-hour administration of Hemopurifier therapy until the point that Ebola viral load drops below 1,000 copies per milliliter of blood. The goal of the study is to standardize and evaluate the use of the product in the treatment of Ebola.
Aethlon previously reported that Hemopurifier therapy was successfully administered to a critically-ill Ebola patient at Frankfurt University Hospital in Germany. The patient’s viral load prior to a 6.5-hour treatment was measured at 400,000 virus copies per milliliter of blood. A post-treatment viral load measurement was reported to be 1,000 copies. The patient was unconscious and suffering from multiple organ failure, but has since made a full recovery and returned home to his family.
Time Magazine recently named the Aethlon Hemopurifier as one of the 25 best inventions of 2014.