US-based Cerus has received FDA approval for its clinical protocol to make the Intercept Blood System for plasma available under an investigational device exemption (IDE) to treat convalescent plasma collected from Ebola disease survivors for passive immune therapy.
Under IDE, the company will start a trial with Emory University Hospital, University of Nebraska Medical Center.
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According to the company, transfusion of blood or plasma from recovered Ebola patients may be of benefit in patients with acute Ebola infections.
Cerus senior vice-president Laurence Corash said: "The Intercept pathogen inactivation process can diminish the risk of other pathogens that may contaminate the plasma of valuable Ebola convalescent donors, and will provide a new therapeutic resource for patients with Ebola."
As part of the trial, Emory University will collect Ebola convalescent plasma from recovered patients, and also perform the Intercept treatment on-site.
The treated plasma will be stored at Emory for use in future patients, after testing for Ebola antibodies at the Centers for Disease Control.
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By GlobalDataIn order to increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America’s Blood Centers.
The collaboration will create a national network of plasma collection sites to access recovered Ebola patients.
Emory University School of Medicine pathology and laboratory medicine assistant professor Anne Winkler said: "Having a supply of convalescent plasma that has been through pathogen inactivation is critical to making this therapy readily available as new Ebola patients are diagnosed and urgently require treatment."
The World Health Organization (WHO) recently identified convalescent plasma as a potentially experimental approach to Ebola virus disease therapy, issuing interim guidance suggesting how the plasma should be sourced and supplied.
The Intercept platelet and plasma systems were approved for use in Europe.
License applications for the systems are under FDA review, with an approval decision expected in 2015.
Image: Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.
