LAKEWOOD, Colo., May 17, 2017 /PRNewswire/ -- Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, announced that the first patient has been enrolled in the Mirasol Platelets in Plasma (MIPLATE) clinical trial using the Mirasol® Pathogen Reduction Technology (PRT) System. The U.S. trial is designed to evaluate the clinical effectiveness of Mirasol-treated apheresis Platelets in Plasma versus standard apheresis Platelets in Plasma.
Enrollment of the first patient marks the beginning of the MIPLATE clinical trial that is intended to support a U.S. Food and Drug Administration (FDA) premarket approval (PMA) application for the Mirasol PRT system. The study is a part of Terumo BCT's ongoing research and dedication to advance global blood safety by developing clinical evidence to support the safety and efficacy of pathogen-reduced blood components. MIPLATE is estimated to take 3.5 years and will involve up to 15 hospitals, corresponding blood centers and 556 patients. Eligible patients have a platelet count of less than or equal to 10,000/µL and require at least two platelet transfusions.
"This study is intended as a step towards improving transfusion therapy and transfusion safety in the U.S.," said Sherrill Slichter, MD, principal investigator from Bloodworks Northwest and lead investigator for the MIPLATE clinical trial. "We're excited to be a part of this study that hopefully will lead to measures that could further protect the nation's blood supply from certain complications and threats of blood transfusions."
MIPLATE is a multi-center, controlled, randomized, non-inferiority study designed to evaluate the clinical effectiveness of Mirasol-treated apheresis Platelets in Plasma versus standard apheresis Platelets in Plasma in patients with hypoproliferative thrombocytopenia. This condition is characterized by low platelet count in patients with compromised bone marrow due to hematologic malignancies or treatments such as chemotherapy.
"In addition to being designed to support our PMA application for U.S. approval, this study is an important part of our ongoing efforts to advance blood safety and patient care," said Palani Palaniappan, Executive Vice President of Innovation & Development, Terumo BCT. "With a better clinical understanding of technologies like the Mirasol PRT system in the U.S., we can bring our customers a safe, simple and effective solution to help protect their patients from pathogens."
About Mirasol PRT System
The Mirasol PRT system is CE marked for platelets, plasma, and whole blood and is in use in approximately 20 countries and 140 blood centers throughout Europe, the Middle East, Africa, Asia and Latin America. The system is for investigational use only in the U.S. and Canada and is available in other select countries.
About Terumo BCT
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600013C.
Bradley Hein, Global Integrated Communications
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SOURCE Terumo BCT