The US Food and Drug Administration (FDA) has approved Cerus’ 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.
According to Cerus, Emory University is equipped to collect Ebola convalescent plasma from recovered patients, and also to perform the Intercept treatment onsite.
The treated plasma will be stored at Emory for use in future patients, following testing for Ebola antibodies at the Centers for Disease Control.
Cerus senior vice president and chief medical officer Dr 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."
Cerus and the trial investigators are partnering with the American Red Cross and America’s Blood Centers to further increase the availability of convalescent plasma. The partnership 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 and clinical study principal investigator 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 Intercept platelet and plasma systems have approval for use in Europe. License applications for the systems are under FDA review, with an approval decision expected in 2015.