FDA Grants IDE for Ebola Plasma Transfusion System
Cerus said Friday that the FDA has given it the go-ahead to begin clinical studies of the INTERCEPT Blood System, which will be used to treat plasma from Ebola survivors before it is transfused into patients currently fighting the disease.
The plasma of people who have recovered from the virus contains antibodies that can help fight Ebola infection in others, but it can also contain common pathogens like bacteria, viruses and parasites, making treatment of the plasma imperative, Cerus says. INTERCEPT is designed to inactivate these pathogens in the convalescent blood plasma before it is transmitted to the patient.
The trial will be conducted at Emory University Hospital in Atlanta and the University of Nebraska Medical Center, two sites that have previously treated Ebola patients and possess the infrastructure and experience for carrying out the procedure, the Concord, Calif., devicemaker said.
Under the investigational device exemption approved by the FDA, Emory will collect plasma from recovered Ebola patients and run it through the INTERCEPT system. The Centers for Disease Control and Prevention will then test the treated plasma for Ebola antibodies and return it to Emory to be stored for future use. Emory will supply treated plasma to the University of Nebraska as needed.
Cerus and the hospitals are also working with the Red Cross and America’s Blood Centers to create a national network of plasma collection sites to recover plasma from Ebola survivors, the company said.
Cerus hopes to win FDA approval for the INTERCEPT system in 2015. It is currently CE-marked. — Kellen Owings
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