We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Aethlon Gets FDA OK to Begin Ebola Treatment Study

Aethlon Gets FDA OK to Begin Ebola Treatment Study

January 5, 2015

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

Devices Research and Development

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Deems Cardiosave Intra-Aortic Balloon Recall Class I

  • Xtandi Shows Promise in Prostate Cancer Trial

  • Implantable Sleeve that Holds Spinal Screws in Place Gets FDA Clearance

  • FDA Green Lights Clinical Trial of Low-Dose Psilocybin

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing