MIRASOL PATHOGEN REDUCTION TREATMENT AS AN ALTERNATIVE TO GAMMA-IRRADIATION IN THE PREVENTION OF TRANSFUSION-ASSOCIATED GRAFT VS. HOST DISEASE (TA-GVHD)

摘要

Functional leukocytes in blood components may be responsible for a number of adverse transfusion effects, including TA-GVHD. Transfusion-associated graft-versus-host disease (TA-GVHD) is usually a fatal clinical condition. Subjecting blood components to gamma-irradiation generated from a cesium-137 chloride (CsCl) source has been the almost universal means of preventing TA-GVHD for many years. CsCl is water soluble and dispersible and could be used malevolently. Its medical use is associated with significant regulatory, technical and clinical concerns and challenges such as transfusion delay, cost, failure to irradiate when indicated, increased potassium accumulation in and decreased shelf life of RBC units, reduced RBC recovery, and onerous security requirements for cesium-137 source irradiators and their operators. A safe, efficacious and affordable alternative means of preventing the devastation of TA-GVHD is very much needed worldwide. Microbial contamination of blood components can pose life-threatening risks for transfusion recipients. Donor history screening and infectious disease testing are a reactive response and expensive, as well as an imperfect and incomplete means for preventing these infectious risks. In response to these threats, pathogen reduction technologies have been developed, such as the Mirasol System. The system employs riboflavin and UV light to induce the oxidation of guanine residues causing irreversible nucleic acid damage. By targeting nucleic acids, the treatment prevents replication of pathogens and leukocytes in blood products. There is strong experimental, animal model and clinical evidence that demonstrates that Mirasol-treated, non-irradiated cellular blood components do not cause TA-GVHD. The device received the CE Mark approval platelets in 2007, for plasma in 2008 and for Whole Blood in 2015. This approval includes an indication for use as an effective alternative to irradiation for preventing TA-GVHD. At present, many institutions in European countries and parts of the Middle East using the Mirasol System are not gamma-irradiating platelets that would otherwise undergo this treatment. No TA-GVHD has been reported with this practice. The Mirasol System treatment of platelets, plasma and whole blood provides a single pathogen reduction and leukocyte inactivation technology for all blood components.