Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Blood
Patent
1998-06-05
1999-11-16
Travers, Russell
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Blood
424 90, 424533, 435173, A61K 3514, A61K 3518, C12N 1300
Patent
active
059853310
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method for in activating parasites in blood and blood products by incubating a mixture of the blood or blood product, a phthalocyanine dye and a quencher and optionally irradiating this mixture with red light. An advantage of the inventive method is that the treatment, when red light is applied, leads to the inactivation of lipid enveloped virus, also contained in the blood or blood product. A further advantage of the instant method is that while the parasites and lipid enveloped viruses are inactivated, blood cells and labile blood proteins contained in the blood or blood product, are not adversely affected.
2. Description of Related Art
It is estimated that 16 to 18 million people are infected world-wide with Chagas disease. This disease is caused by the parasite Trypanosoma cruzi and is endemic to Latin America. A large proportion of immigrants from Latin America to the United States are from areas where the prevalence of the pathogenic agent T. cruzi is high. It is estimated that at least 50,000 people infected with T. cruzi have emigrated to the U.S.A. In addition to insect vectors, another route of infection is transfusion and this is an emerging problem in the United States. Often the infection caused by T. cruzi is chronic and the majority of carriers initially display only mild symptoms. The infectious form of the parasite, trypomastigotes, circulate in the infected individual's blood and is capable of surviving the blood banking process and storage. No serological test for T. cruzi in blood banks has been approved by the FDA for use in the U.S.A. at this time. The inadequacy of identification and screening muethods makes it imperative to inactivate the parasite in transfused blood.
While the most serious form of malaria, caused by Plasmodium falciparum, is usually transmitted by a mosquito vector, it may also be transmitted by blood transfusion from asymptomatic donors. Almost all blood components, including red cells, platelet concentrates, white cells, cryoprecipitates and fresh plasma transmit malaria. Malaria parasites can survive storage in red blood cells at 2 degrees to 6 degrees for days to weeks or even years. The FDA's Blood Products Advisory Committee has issued recommendations for deferring blood donors at increased risk for malaria, however, these recommendations apply only to donations containing intact red blood cells. Donations used for preparing plasma, plasma components, or derivatives devoid of intact red blood cells are excluded from these regulations. Consequently, absolute safety from transfusion derived malaria is not insured. It is expected that increased immigration and travel from malaria endemic areas will intensify the risk of malaria through transfusion of red blood cell concentrates (RBCC) and platelet concentrates (PC).
Transmission of pathogenic viruses by blood transfusion has been reduced in recent years by serological screening for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). However, absolute safety has not been achieved and the risk of HBV, HCV and HIV-1 transmission in the USA with a single blood unit has been estimated at 0.0005%, 0.03% and 0.0005%, respectively (R. Y. Dodd, "The Risk of transfusion-transmitted infection", N. Enc. J. Med., 327, 419-21, 1992). Patients who received a large number of RBCC are at a much higher risk of virus transmission. Other viruses of concern in patients with compromised immune systems are cytomegalovirus (CMV) and parvovirus.
Sterilization appears to be the best way to ensure a very high level of safety in transfusion of blood and its components. Currently, all blood products are available in sterilized forms with the exception of red blood cell and platelet concentrates. Sterilization of cellular blood components presents a unique challenge because cell structure and function are disrupted more easily than those of individual proteins. Various approaches have been taken for virus sterilization of r
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Ben-Hur Ehud
Gottlieb Paul
Lustigman Sara
New York Blood Center Inc.
Travers Russell
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