Leucodepletion for transmissible spongiform encephalopathies
Transmissible spongiform encephalopathies (TSEs) have been recognised around the world for many years. Creutzfeldt-Jakob disease (CJD), one of the human forms of TSE, has been studied widely and thus far has not proved a great threat to human health. The emergence of two new TSEs--bovine spongiform encephalopathy (BSE) in cattle and variant Creutzfeldt-Jakob disease (vCJD) in humans in the UK--has caused great concern. BSE has had an economic impact and vCJD is a threat to human health. It has been shown that these two diseases are caused by the same prion agent and are linked. Research indicates that vCJD behaves differently to CJD and there is strong evidence to suggest that vCJD is present in lymphoid tissues and B lymphocytes, which presents a theoretical risk that it may be transmitted by transfusion of blood and blood products. To minimise/prevent this risk, the UK government has decided that plasma should be sourced from abroad and has instructed the National Blood Service to leucodeplete all blood and blood products, at a cost of 70 million pounds per annum, although it is not known if this will remove this risk.
Available from: Marc L Turner
- "The measure was predicated on studies suggesting that B lymphocytes were likely to be involved in the initial phases of disease and that leucocytes were an important locus of infectivity in the peripheral blood. Subsequently, it has become apparent that in animal studies leucodepletion does not reduce infectivity in plasma and is likely to reduce the prion concentration in blood by only about 40% (Prowse & Bailey, 2000; Gregori et al, 2004; St Romaine et al, 2004). Universal leucodepletion is also considered to offer a number of additional benefits, e.g. "
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ABSTRACT: Whereas plasma-derived clotting factor concentrates now have a very good safety record for not being infectious for lipid enveloped viruses, concern has arisen about the possibility that prion diseases might be transmitted by blood products. There is epidemiological evidence that classical sporadic Creutzfeld Jakob disease (CJD) is not transmitted by blood transfusion. There is now good evidence that the abnormal prion associated with variant CJD can be transmitted by transfusion of fresh blood components and infect recipients. To reduce the risk of the pathological prion in the UK infecting recipients of clotting factor concentrates, these are now only manufactured from imported plasma collected from countries where there has not been bovine spongiform encephalopathy (BSE) in cattle and the risk of variant CJD in the population is, therefore, considered negligible. The safety of these concentrates is also enhanced because prion protein is, to an appreciable extent, excluded by the manufacturing process from the final product. To help reduce the chance of prion transmission by fresh blood products, donations are leucodepleted, there is increasing use of imported fresh frozen plasma (especially for treating children) and potential donors, who have been recipients of blood since 1980 (the beginning of the BSE epidemic in cattle) are deferred.
British Journal of Haematology 02/2006; 132(1):13-24. DOI:10.1111/j.1365-2141.2005.05796.x · 4.71 Impact Factor
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ABSTRACT: The viral and transmissible spongiform encephalopathy (TSE) safety of therapeutics of biological origin (biologicals) is greatly influenced by the nature and degree of variability of the source material and by the mode of purification. Plasma-derived and recombinant DNA products currently have good viral safety records, but challenges remain. In general, large enveloped viruses are easier to remove from biologicals than small 'naked' viruses. Monoclonal antibodies and recombinant DNA biopharmaceuticals are derived from relatively homogeneous source materials and purified by multistep schemes that are robust and amenable to scientific analysis and engineering improvement. Viral clearance is more challenging for blood and cell products, as they are complex and labile. Source selection (e.g. country of origin, deferral for CJD risk factors) currently occupies the front line for ensuring that biologicals are free of TSE agents, but robust methods for their clearance from products are under development.
Current Opinion in Biotechnology 11/2005; 16(5):561-7. DOI:10.1016/j.copbio.2005.07.006 · 7.12 Impact Factor
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ABSTRACT: The improvement of transfusion medicine technology is an ongoing process primarily directed at increasing the safety of allogeneic blood component transfusions for recipients. Over the years, relatively little attention had been paid to the leukocytes present in the various blood components. The availability of leukocyte removal (leukoreduction) techniques for blood components is associated with a considerable improvement in various clinical outcomes. These include a reduction in the frequency and severity of febrile transfusion reactions, reduced cytomegalovirus transfusion-transmission risk, the reduced incidence of alloimmune platelet refractoriness, a possible reduction in the risk of transfusion-associated variant Creutzfeldt-Jakob disease transmission, as well as reducing the overall risk of both recipient mortality and organ dysfunction, particularly in cardiac surgery patients and possibly in other categories of patients. Internationally, 19 countries have implemented universal leukocyte reduction (ULR) as part of their blood safety policy. The main reason for not implementing ULR in those countries that have not appears to be primarily concerns over costs. Nonetheless, the available international experience supports the concept that ULR is a process that results in improved safety of allogeneic blood components.
Hematology/ Oncology and Stem Cell Therapy 04/2008; 1(2):106-23. DOI:10.1016/S1658-3876(08)50042-2
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