Aethlon Gets FDA OK to Begin Ebola Treatment Study
The FDA has approved a clinical study of Aethlon Medical’s Hemopurifier as a treatment for Ebola patients.
The protocol calls for the device to be evaluated in up to 20 patients at as many as 10 U.S. sites. Subjects will receive Hemopurifier therapy for six to eight hours daily until their Ebola viral load drops below 1000 copies/ml, Aethlon said Jan. 2.
The Hemopurifier eliminates viruses and immune-suppressing proteins by filtering infected blood through a bundle of hollow, porous fibers enclosed in a cylindrical plastic case.
Pressure from a blood pump pushes a fraction of the plasma through a porous membrane, leaving the cellular components of the blood inside the fibers. Once that is done, the virus passes through the membrane’s pores and is absorbed by affinity resin just outside the fibers. The plasma then reenters the fibers and recombines with the blood, which is reintroduced into the patient with a much lower concentration of viruses, according to the San Diego, Calif., company.
The Ebola treatment protocol builds on a previously approved study of Hemopurifier therapy in patients infected with HIV and hepatitis C. In October, Aethlon reported that the device had been successfully used to treat an Ebola patient in Germany. — Kellen Owings