The Experts below are selected from a list of 66 Experts worldwide ranked by ideXlab platform
S. Rico - One of the best experts on this subject based on the ideXlab platform.
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red blood cell concentrates treated with the amustaline s 303 Pathogen Reduction System and stored for 35 days retain post transfusion viability results of a two centre study
Vox Sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
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Red blood cell concentrates treated with the amustaline (S‐303) Pathogen Reduction System and stored for 35 days retain post‐transfusion viability: results of a two‐centre study
Vox sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
Jose A. Cancelas - One of the best experts on this subject based on the ideXlab platform.
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red blood cell concentrates treated with the amustaline s 303 Pathogen Reduction System and stored for 35 days retain post transfusion viability results of a two centre study
Vox Sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
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Red blood cell concentrates treated with the amustaline (S‐303) Pathogen Reduction System and stored for 35 days retain post‐transfusion viability: results of a two‐centre study
Vox sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
Adonis Stassinopoulos - One of the best experts on this subject based on the ideXlab platform.
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Inactivation of Plasmodium falciparum in whole blood using the amustaline and glutathione Pathogen Reduction technology.
Transfusion, 2020Co-Authors: Cissé Sow, Andrew Laughhunn, Yvette A. Girard, Marion C. Lanteri, Soraya Amar El Dusouqui, Adonis Stassinopoulos, Philippe GrellierAbstract:Background Risk of transfusion-transmitted (TT) malaria is mainly associated with whole blood (WB) or red blood cell (RBC) transfusion. Risk mitigation relies mostly on donor deferral while a limited number of countries perform blood testing, both negatively impacting blood availability. This study investigated the efficacy of the Pathogen Reduction System using amustaline and glutathione (GSH) to inactivate Plasmodium falciparum in WB. Study design and methods WB units were spiked with ring stage P. falciparum infected RBCs. Parasite loads were measured in samples at time of infection, after 24 hours at room temperature (RT), and after a 24-hour incubation at RT post-treatment with 0.2 mM amustaline and 2 mM GSH. Serial 10-fold dilutions of the samples were inoculated to RBC cultures and maintained up to 4 weeks. Parasitemia was quantified by cytometry. Results The P. falciparum viability assay has a limit of detection of a single live parasite per sample. Input parasite titer was >5.7 log10 TCID50 per mL. A 24-hour incubation at RT paused parasite development in controls, but they retained viability and infectivity when tested in culture. In contrast, no infectious parasites were detected in the amustaline/GSH-treated sample after 4 weeks of culture. Conclusion A robust level of P. falciparum inactivation was achieved in WB using amustaline/GSH treatment. Parasite log Reduction was >5.7 log10 TCID50 per mL. Development of such a Pathogen Reduction System may provide an opportunity to reduce the risk of TT malaria and improve blood availability.
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Inactivation of chikungunya virus in blood components treated with amotosalen/ultraviolet A light or amustaline/glutathione.
Transfusion, 2018Co-Authors: Andrew Laughhunn, Marion C. Lanteri, Yan-jang S. Huang, Dana L. Vanlandingham, Adonis StassinopoulosAbstract:Chikungunya virus, a mosquito-borne arbovirus, often co-circulates with the Zika, dengue, and yellow fever viruses in Aedes mosquito-infested areas where cases of arbovirus transfusion-transmitted infections have been reported. Building on past experience to help maintain the availability of safe components during major outbreaks of chikungunya virus in La Reunion, Italy, and Thailand and of Zika virus in the Pacific, the Caribbean, and the Americas, Pathogen inactivation is a mitigation strategy to reduce the risk of transfusion-transmitted infection. Inactivation of chikungunya virus was investigated for platelets in 100% plasma using amotosalen/ultraviolet A light, and in red blood cells using amustaline/glutathione.Platelets in 100% plasma and red blood cells (RBCs) were spiked with chikungunya virus. Infectious chikungunya virus titers were measured in contaminated blood products before and after treatment with amotosalen/ultraviolet A light for platelets in 100% plasma and after treatment with amustaline/glutathione for RBCs. Viral infectivity was quantified by plaque assay.The mean chikungunya virus infectivity titers before inactivation were 6.50 log10 plaque-forming units/mL for platelets in 100% plasma and 7.60 log10 plaque-forming units/mL for RBCs. No infectivity was detected after amotosalen/ultraviolet A light or amustaline/glutathione treatment, corresponding to greater than 6.5 log10 plaque-forming units/mL and greater than 7.1 log10 plaque-forming units/mL of inactivation, respectively.Robust levels of chikungunya virus inactivation were achieved for platelets in 100% plasma and for RBC components. The licensed amotosalen/ultraviolet A light technology and the amustaline/glutathione Pathogen-Reduction System under development may provide an opportunity for comprehensive mitigation of the risk of chikungunya virus transfusion-transmitted infection by plasma, platelets, and RBCs.
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Inactivation of chikungunya virus in blood components treated with amotosalen/ultraviolet A light or amustaline/glutathione.
Transfusion, 2018Co-Authors: Andrew Laughhunn, Marion C. Lanteri, Yan-jang S. Huang, Dana L. Vanlandingham, Adonis StassinopoulosAbstract:Background Chikungunya virus, a mosquito-borne arbovirus, often co-circulates with the Zika, dengue, and yellow fever viruses in Aedes mosquito-infested areas where cases of arbovirus transfusion-transmitted infections have been reported. Building on past experience to help maintain the availability of safe components during major outbreaks of chikungunya virus in La Reunion, Italy, and Thailand and of Zika virus in the Pacific, the Caribbean, and the Americas, Pathogen inactivation is a mitigation strategy to reduce the risk of transfusion-transmitted infection. Inactivation of chikungunya virus was investigated for platelets in 100% plasma using amotosalen/ultraviolet A light, and in red blood cells using amustaline/glutathione. Study design and methods Platelets in 100% plasma and red blood cells (RBCs) were spiked with chikungunya virus. Infectious chikungunya virus titers were measured in contaminated blood products before and after treatment with amotosalen/ultraviolet A light for platelets in 100% plasma and after treatment with amustaline/glutathione for RBCs. Viral infectivity was quantified by plaque assay. Results The mean chikungunya virus infectivity titers before inactivation were 6.50 log10 plaque-forming units/mL for platelets in 100% plasma and 7.60 log10 plaque-forming units/mL for RBCs. No infectivity was detected after amotosalen/ultraviolet A light or amustaline/glutathione treatment, corresponding to greater than 6.5 log10 plaque-forming units/mL and greater than 7.1 log10 plaque-forming units/mL of inactivation, respectively. Conclusion Robust levels of chikungunya virus inactivation were achieved for platelets in 100% plasma and for RBC components. The licensed amotosalen/ultraviolet A light technology and the amustaline/glutathione Pathogen-Reduction System under development may provide an opportunity for comprehensive mitigation of the risk of chikungunya virus transfusion-transmitted infection by plasma, platelets, and RBCs.
J. L. Gottschall - One of the best experts on this subject based on the ideXlab platform.
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red blood cell concentrates treated with the amustaline s 303 Pathogen Reduction System and stored for 35 days retain post transfusion viability results of a two centre study
Vox Sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
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Red blood cell concentrates treated with the amustaline (S‐303) Pathogen Reduction System and stored for 35 days retain post‐transfusion viability: results of a two‐centre study
Vox sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
A. Erickson - One of the best experts on this subject based on the ideXlab platform.
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red blood cell concentrates treated with the amustaline s 303 Pathogen Reduction System and stored for 35 days retain post transfusion viability results of a two centre study
Vox Sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.
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Red blood cell concentrates treated with the amustaline (S‐303) Pathogen Reduction System and stored for 35 days retain post‐transfusion viability: results of a two‐centre study
Vox sanguinis, 2017Co-Authors: Jose A. Cancelas, J. L. Gottschall, Neeta Rugg, Sharon Graminske, M. A. Schott, Anne North, N. Huang, Nina Mufti, A. Erickson, S. RicoAbstract:Background and Objectives Pathogen Reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and Methods In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51Cr/99mTc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC) were analysed. Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83·2 ± 5·2 and 84·9 ± 5·9%, respectively; P = 0·06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T50 between Test and Control RBCs (33·5 and 39·7 days, respectively; P 0·05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events. Conclusion RBCs prepared using amustaline Pathogen Reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.