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Trial Testing Blood Filter Device for Hepatitis C Virus

Microscopic view of the hepatitis C virus (VA.gov)

Microscopic view of the hepatitis C virus (VA.gov)

11 December 2014. Aethlon Medical Inc. is beginning patient recruitment for  an early-stage safety and feasibility study of its blood filtration device with patients in kidney dialysis who also have hepatitis C. The San Diego medical device developer plans to test the Hemopurifier device at DaVita Medical Center in Houston.

Patients with kidney disease needing dialysis face a somewhat higher risk of contracting hepatitis B and C from exposure to blood of another patient with hepatitis B or C viruses. While a vaccine exists for hepatitis B, there is no such vaccine for hepatitis C. According to National Kidney Foundation, the chance of contracting hepatitis B or C from dialysis is small because of infection control measures taken by dialysis centers, but the foundation recommends hepatitis C testing for long-term dialysis patients.

Aethlon Medical’s Hemopurifier is a device that reduces viral pathogens in the blood stream, including HIV and hepatitis C, as well as other pandemic threats including Ebola. The company says previous studies, including human trials, show Hemopurifier reduces viral loads by 50 percent during a 4-hour treatment. A clinical trial in India is testing the device in combination with standard hepatitis C care for its ability to accelerate reductions in viral loads.

In the new clinical trial, Aethlon is recruiting 10 patients with end-stage renal disease and diagnosed with hepatitis C. The patients will first be checked for vital signs, blood chemistries, liver function, and adverse events during a 1-week period with 3 standard dialysis sessions. The patients will then be given Hemopurifier treatments 3 times a week in conjunction with their dialysis sessions during weeks 2 and 3.

The trial’s main objective is to test for safety of the device with this patient population, measured by the rate of adverse events occurring during the test period. The trial is also testing for clinical benefits, in this case effect on viral loads — level of virus in the blood — as well as number of viral copies or virus particles.

Aethlon says once safety of the device is determined, it expects to begin late-stage trials of the Hemopurifier as a treatment for a variety of chronic viral diseases, including pandemic and bioterror threats. The company says it also plans to petition FDA for a humanitarian exemption to use the Hemopurifier with Ebola and orphan disease cases. Aethlon says the device was tested in the lab with Ebola, dengue, and lassa hemorrhagic viruses, 2009 H1N1 influenza, reconstructed 1918 influenza, and monkeypox as a model for smallpox.

The company is also testing the Hemopurifier with exosomes — nanoscale sacs filled with fluids — associated with cancer, in collaboration with Sarcoma Oncology Center in Santa Monica, California. This research is investigating the ability of the device to remove exosomes suppressing the immune system from blood of advanced-stage cancer patients.

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