San Diego-based Aethlon Medical, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved the use of its Aethlon Hemopurifier® bio-filtration device in a clinical protocol for Ebola treatment. The approval allows for an investigational study at up to 10 U.S. locations with up to 20 U.S. subjects.
According to PRNewswire, Aethlon’s Ebola protocol was submitted to the FDA as a supplement to a previously approved Investigation Device Exemption (IDE) under which Aethlon is conducting a clinical feasibility study of Humopurifier® therapy in Hepatitis C patients who are also receiving chronic dialysis therapy. Aethlon previously reported that the Hemopurifier® was used to treat a critically-ill Ebola patient at Frankfurt University Hospital in Germany. According to Aethlon’s website, the device has also been used to reduce viral load in HIV patients, and in vitro studies have shown it captures exosomes underlying various types of cancer. Fierce Medical Devices reports that a collaboration between Aethlon and the Sarcoma Oncology Center (SOC), which is based in Santa Monica, California, is studying the ex vivo effectiveness of the Hemopurifier® to remove exosomes from the blood of advanced-stage cancer patients.