​​​LAKEWOOD, Colo., U.S.A. – Terumo Blood and Cell Technologies is voluntarily ending the Mirasol Platelets in Plasma study (MIPLATE) with agreement from the study funder. This decision is based on an independent data monitoring committee's opinion that MIPLATE would not be able to reach its primary efficacy endpoint.

There are no patient safety concerns related to the Mirasol^® Pathogen Reduction Technology (PRT) System.

Mirasol is designed to add an extra layer of safety to the blood supply. It is part of our larger commitment to promote a safe, sustainable and adequate blood supply around the world. It is in routine use at more than 100 blood centers and in over 20 countries in Europe, the Middle East, Africa, Asia and Latin America.

The MIPLATE study was evaluating how Mirasol-treated platelets perform compared to untreated platelets. Mirasol platelets have demonstrated efficacy in the prevention of clinically important bleeding in previous clinical studies.^1,2

The decision to stop the study was based on the fact that it was unlikely to meet its objectives. This could mean that not enough people would be in the study, which was designed to evaluate 558 patients. Terumo Blood and Cell Technologies plans to evaluate the data, as we strive for continuous improvement.

About Mirasol
Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.

The Mirasol PRT system is a CE marked medical device intended to reduce the pathogen load and inactivate residual white blood cells in donor plasma, platelet concentrates and whole blood for transfusion. It has been in routine use since 2007. It is used in more than 100 blood centers in over 20 countries throughout Europe, the Middle East, Africa, Asia and Latin America. The system is not approved for sale in the U.S., where it is used for research and investigative purposes.

Funding for the MIPLATE multi-center U.S. clinical trial came from the Biomedical Advanced Research and Development Authority (BARDA). BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services that provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. BARDA officials agree with Terumo Blood and Cell Technologies' decision to stop the study.

FAQ

Do you have concerns about the safety of Mirasol?

• No, we do not have safety concerns about Mirasol, which has been in routine use since 2007. The Mirasol PRT system is a CE marked medical device intended to reduce the pathogen load and inactivate residual white blood cells in donor plasma, platelet concentrates and whole blood for transfusion. It is in routine use at more than 100 blood centers in over 20 countries in Europe, the Middle East, Africa, Asia and Latin America.

What are the benefits of Mirasol?

• Mirasol offers two main advantages compared to untreated platelets: pathogen reduction and white blood cell inactivation, which may reduce transfusion reactions in patients.
• Mirasol is designed to add an extra layer of safety to the blood supply. It is part of our work to promote a safe, sustainable and adequate blood supply around the world.
• In some parts of the world where Mirasol is approved for use, the device is used to treat convalescent plasma for COVID-19 patients. Convalescent plasma for treatment of COVID-19 is experimental and is currently being investigated to determine whether it is effective.³
• Mirasol reduces the virus causing COVID-19 (SARS-CoV-2) below the limit of detection in plasma and platelets.^4,5
• The device demonstrated reduction of MERS-CoV, a strain of coronavirus, in blood products.⁶
• Mirasol-treated platelets show no clinical difference in reducing bleeding compared to conventional platelets in plasma, as shown in a peer-reviewed clinical study.²
• ​Mirasol demonstrated a significant reduction of malaria transmission from whole blood transfusions in a clinical study.⁷

Should patients involved in MIPLATE be concerned?

• There are no concerns for patient safety related to Mirasol-treated blood components or whole blood. The voluntary decision to stop the MIPLATE study is based the inability to meet the study's objectives.

Will you still support Mirasol in markets where it is approved?

• ​Yes. We will continue supporting Mirasol in the markets where it is currently approved and in prospective markets. Mirasol is part of our larger commitment to promote a safe, sustainable and adequate blood supply around the world.

¹https://www.terumobct.com/public/306690407.pdf​

²https://www.terumobct.com/public/306690404.pdf

³I n the U.S., the Food and Drug Administration (FDA) has released guidance for Investigational COVID-19 Convalescent Plasma outlining donor and patient qualifications as well as how to obtain authorization. Physicians or hospitals who would like to provide convalescent plasma to patients should work with local blood collection establishments. Collection of convalescent plasma should comply with local regulatory requirements for donor qualification and blood product testing

⁴Study funded by Terumo BCT and conducted at Colorado State University, Fort Collins, Colo.; Authors: From Terumo BCT: Shawn D. Keil, Susan Yonemura and Nicole K. Dart. From CSU's Department of Biomedical Sciences, Fort Collins, Colo.: Izabela Ragan and Richard Bowen. From CSU's Infectious Disease Research Center, Fort Collins, Colo.: Lindsay Hartson. Read the full article, Inactivation of severe acute respiratory syndrome coronavirus 2 in plasma and platelet products using a riboflavin and ultraviolet light-based photochemical treatment, here. The International Society for Blood Transfusion (ISBT) Global Blood Safety Working Party recommends, where feasible, pathogen inactivation of plasma to control residual risks of transfusion-transmitted infectious diseases and to alleviate concern about possible superinfections with SARS-CoV-2, the virus that causes COVID-19. Jay Epstein and Thierry Burnouf, on behalf of the ISBT Working Party on Global Blood Safety. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Details here.

⁵https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233947

⁶Keil SD, Bowen R, Marschner S. Inactivation of Middle East respiratory syndrome coronavirus (MERS‐CoV) in plasma products using a riboflavin‐based and ultraviolet light‐based photochemical treatment. Transfusion. 2016;56:2948-2952. https://onlinelibrary.wiley.com/doi/full/10.1111/trf.13860

⁷Allain JP, et al., "Prevention of Transfusion-Transmitted Malaria by Treatment of Whole Blood With the Mirasol PRT System." Blood. 2015;126(23):770.

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