The Praise study has been designed to offer the clinical evidence needed to support submission of Mirasol to the US Food and Drug Administration (FDA) for premarket approval (PMA).
Mirasol system is being developed to use riboflavin (vitamin B2) and ultraviolet light to decrease the pathogen load of different disease-causing viruses, bacteria and parasites in whole blood before it is divided into components and the red blood cells are transfused to patients.
The trial, which is sponsored by the Department of Defense (DOD), compares red blood cells derived from Mirasol-treated whole blood against untreated red blood cells transfused to patients diagnosed with thalassemia, which is a genetic blood disorder develops due to lack of hemoglobin.
Army Blood Program director Army Col. Audra Taylor said: "FDA approval of Mirasol will further enhance the safety of blood transfused to our Warfighters in combat as well as U.S. civilians."
The prospective, multicenter, randomized and crossover trial will recruit around 100 patients, and is expected to complete in 2.5 years.
Terumo BCT innovation and development executive vice president Palani Palaniappan said: "Terumo BCT is committed to advancing a safe global blood supply, which includes bringing Mirasol to the U.S. market.”
Mirasol system secured CE mark approval for platelets, plasma and whole blood, and is currently marketed in around 20 countries and 140 blood centers across the Europe, the Middle East, Africa, Asia and Latin America.
The system is being used for only investigation in the US and Canada. It is also available in other selected countries.
Terumo BCT provides blood component, therapeutic apheresis and cellular technologies,a nd is claimed to be the only firm with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies.
Image: Terumo BCT’s Mirasol system. Photo: courtesy of PRNewswire / Terumo BCT.
