FDA To Issue Guidelines For Using San Diego Device On Ebola Patients

A San Diego company that makes a blood purification device announced Wednesday that the U.S. Food and Drug Administration will issue guidelines for using the product on some Ebola patients.

The hemopurifier, made by Aethlon Medical of San Diego, has not received FDA approval for general use in the United States.

It was being tested on HIV/AIDS and Hepatitis C patients overseas before the recent breakout of Ebola in West Africa, leading to the first patients with the virus in this country.

The device can be hooked directly to a patient by a tube or attached to a dialysis machine 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.

"The administration of hemopurifier therapy in Germany has reinforced the need to clarify defined regulatory pathways that might allow us to treat Ebola infection in the United States," Joyce said. "As it relates to the patient treated in Germany, we respect patient confidentiality and will report on his response to therapy after Frankfurt University Hospital officials provide an update on his condition."

The FDA will issue "compassionate use" guidelines for the hemopurifier so qualified physicians can use the device to treat serious illnesses that lack alternative remedies, according to Aethlon.

According to the company, compassionate use provisions are typically approved by the FDA on an individual patient basis, but can be expanded to include a small group.

Joyce said the company will also supply data from the device's use in Germany to the federal agency in an effort to approve wider use.

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