FDA To Test San Diego Company's Ebola Treatment Device
A blood filtration device that was developed in San Diego and can be used on Ebola patients has been cleared for further testing by the U.S. Food and Drug Administration, Aethlon Medical announced Friday.
The company said its hemopurifier will be tested at 10 sites for up to 20 U.S. patients. The goal of the study is to standardize and evaluate the use of the device in the treatment of Ebola.
An outbreak of the disease last year in three West African countries killed nearly 8,000 people and, for the first time, patients brought the virus to U.S. soil.
More than 20,200 people have been sickened in the outbreak, mainly in Guinea, Liberia, Mali and Sierra Leone, but also some in Nigeria, Senegal, Spain and the U.S., according to the World Health Organization.
The hemopurifier was being tested on HIV/AIDS and hepatitis C patients overseas before the recent Ebola breakout.
The device can be hooked directly to a patient via a tube or attached to a dialysis machine in order to remove large quantities of the Ebola virus and proteins the disease creates to suppress the immune system, according to Aethlon founder and CEO Jim Joyce.
The hemopurifier was used in Germany on a physician who became sick while treating Ebola patients in Sierra Leone.
According to Aethlon, what's known as the "viral load" of Ebola in the critically ill doctor was 400,000 virus copies per milliliter of blood. After a 6 1/2-hour treatment, the load was reduced to 1,000 copies. The treatment was well tolerated with no adverse events reported, Aethlon reported.
The company said that at the time of treatment, the physician was unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications.
The patient has since made a full recovery and returned home to his family.