CaridianBCT, a developer and marketer of blood collection and processing systems to hospitals and blood banks, has initiated a clinical trial for treating whole blood with Mirasol pathogen reduction technology after receiving clearance from the FDA and US Department of Defense.
The Mirasol pathogen reduction technology (PRT) system is a proprietary technology that uses riboflavin and UV light to reduce the levels of infectious pathogens and inactivate white cells from collected blood, improving the safety of transfused blood.
The study, which has started enrolling subjects, will take six to 12 months to complete and is a feasibility study designed to support filing for regulatory approvals in the US. The trial is sponsored by CaridianBCT Biotechnologies and is being conducted at the Hoxworth Blood Center in Cincinnati, Ohio.
CaridianBCT Biotechnologies has received research funding from the US Department of Defense with the goal to develop a transportable system to treat whole blood and reduce the risks associated with blood-borne pathogens and donor white cells.
This clinical study will evaluate platelet, plasma and red cell products during storage. The in vivo behavior of red cells will be evaluated in this study in healthy subjects after treatment of the products with the Mirasol PRT system. The objective of the study is to ensure that the system maintains performance of treated components.
David Perez, president and CEO of CaridianBCT, said: “We continue to be honored to work under the sponsorship of the US Department of Defense in spearheading the development and testing of the industry’s first transportable pathogen reduction technology system. Patients, no matter where they are located, may clearly benefit from this simple, safe, and effective technology.”