Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina

Autores
Martinez, M. C.; Rodriguez, R.; Marinsaldi, Melisa Anahi; Rodriguez, G. R.; Guglielmone, Hugo; Bernardi, M. E.; Valdomero, Analía; Cuadra, Gabriel R.
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Despite this, we considered it important to conduct studies to assess the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model. FIXpd were inject doses of 100 or 200 IU F IX kg-1 and some samples were supplemented with heparin (<0.5 of heparin/ IU FIX). Eight rats were tested at each dose level in the presence or absence of heparin, considering those samples with a thrombogenicity ≥2.0 as of potential thrombogenic risk. The mean scores ± SD 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. At both doses tested of FIXpd in the absence of heparin, there was no significant difference in mean scores (P<0.05). The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderivados.
Fil: Martinez, M. C.. Universidad Nacional de Córdoba; Argentina
Fil: Rodriguez, R.. Universidad Nacional de Córdoba; Argentina. Universidad Nacional de Córdoba; Argentina
Fil: Marinsaldi, Melisa Anahi. Universidad Nacional de Córdoba. Facultad de Ciencias Agropecuarias; Argentina
Fil: Rodriguez, G. R.. Universidad Nacional de Córdoba; Argentina
Fil: Guglielmone, Hugo. Universidad Nacional de Córdoba; Argentina
Fil: Bernardi, M. E.. Universidad Nacional de Córdoba; Argentina
Fil: Valdomero, Analía. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; Argentina
Fil: Cuadra, Gabriel R.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; Argentina
Materia
FACTOR IX
THROMBOGENICITY
ANIMAL MODELS
COAGULATION FACTOR
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/183618
Acceder
id CONICETDig_51426396c655ef8b10e8c22f8b9131f3
oai_identifier_str oai:ri.conicet.gov.ar:11336/183618
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in ArgentinaMartinez, M. C.Rodriguez, R.Marinsaldi, Melisa AnahiRodriguez, G. R.Guglielmone, HugoBernardi, M. E.Valdomero, AnalíaCuadra, Gabriel R.FACTOR IXTHROMBOGENICITYANIMAL MODELSCOAGULATION FACTORhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3The risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Despite this, we considered it important to conduct studies to assess the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model. FIXpd were inject doses of 100 or 200 IU F IX kg-1 and some samples were supplemented with heparin (<0.5 of heparin/ IU FIX). Eight rats were tested at each dose level in the presence or absence of heparin, considering those samples with a thrombogenicity ≥2.0 as of potential thrombogenic risk. The mean scores ± SD 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. At both doses tested of FIXpd in the absence of heparin, there was no significant difference in mean scores (P<0.05). The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderivados.Fil: Martinez, M. C.. Universidad Nacional de Córdoba; ArgentinaFil: Rodriguez, R.. Universidad Nacional de Córdoba; Argentina. Universidad Nacional de Córdoba; ArgentinaFil: Marinsaldi, Melisa Anahi. Universidad Nacional de Córdoba. Facultad de Ciencias Agropecuarias; ArgentinaFil: Rodriguez, G. R.. Universidad Nacional de Córdoba; ArgentinaFil: Guglielmone, Hugo. Universidad Nacional de Córdoba; ArgentinaFil: Bernardi, M. E.. Universidad Nacional de Córdoba; ArgentinaFil: Valdomero, Analía. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; ArgentinaFil: Cuadra, Gabriel R.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; ArgentinaAustin Publishing Group2021-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/183618Martinez, M. C.; Rodriguez, R.; Marinsaldi, Melisa Anahi; Rodriguez, G. R.; Guglielmone, Hugo; et al.; Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina; Austin Publishing Group ; Annals of hematology and oncology; 8; 5; 5-2021; 1343-13452375-7965CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://austinpublishinggroup.com/hematology/fulltext/hematology-v8-id1343.phpinfo:eu-repo/semantics/altIdentifier/doi/10.26420/annhematoloncol.2021.1343info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:09:49Zoai:ri.conicet.gov.ar:11336/183618instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-22 11:09:49.395CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
title Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
spellingShingle Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
Martinez, M. C.
FACTOR IX
THROMBOGENICITY
ANIMAL MODELS
COAGULATION FACTOR
title_short Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
title_full Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
title_fullStr Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
title_full_unstemmed Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
title_sort Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina
dc.creator.none.fl_str_mv Martinez, M. C.
Rodriguez, R.
Marinsaldi, Melisa Anahi
Rodriguez, G. R.
Guglielmone, Hugo
Bernardi, M. E.
Valdomero, Analía
Cuadra, Gabriel R.
author Martinez, M. C.
author_facet Martinez, M. C.
Rodriguez, R.
Marinsaldi, Melisa Anahi
Rodriguez, G. R.
Guglielmone, Hugo
Bernardi, M. E.
Valdomero, Analía
Cuadra, Gabriel R.
author_role author
author2 Rodriguez, R.
Marinsaldi, Melisa Anahi
Rodriguez, G. R.
Guglielmone, Hugo
Bernardi, M. E.
Valdomero, Analía
Cuadra, Gabriel R.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv FACTOR IX
THROMBOGENICITY
ANIMAL MODELS
COAGULATION FACTOR
topic FACTOR IX
THROMBOGENICITY
ANIMAL MODELS
COAGULATION FACTOR
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv The risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Despite this, we considered it important to conduct studies to assess the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model. FIXpd were inject doses of 100 or 200 IU F IX kg-1 and some samples were supplemented with heparin (<0.5 of heparin/ IU FIX). Eight rats were tested at each dose level in the presence or absence of heparin, considering those samples with a thrombogenicity ≥2.0 as of potential thrombogenic risk. The mean scores ± SD 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. At both doses tested of FIXpd in the absence of heparin, there was no significant difference in mean scores (P<0.05). The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderivados.
Fil: Martinez, M. C.. Universidad Nacional de Córdoba; Argentina
Fil: Rodriguez, R.. Universidad Nacional de Córdoba; Argentina. Universidad Nacional de Córdoba; Argentina
Fil: Marinsaldi, Melisa Anahi. Universidad Nacional de Córdoba. Facultad de Ciencias Agropecuarias; Argentina
Fil: Rodriguez, G. R.. Universidad Nacional de Córdoba; Argentina
Fil: Guglielmone, Hugo. Universidad Nacional de Córdoba; Argentina
Fil: Bernardi, M. E.. Universidad Nacional de Córdoba; Argentina
Fil: Valdomero, Analía. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; Argentina
Fil: Cuadra, Gabriel R.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Farmacología Experimental de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Farmacología Experimental de Córdoba; Argentina
description The risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Despite this, we considered it important to conduct studies to assess the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model. FIXpd were inject doses of 100 or 200 IU F IX kg-1 and some samples were supplemented with heparin (<0.5 of heparin/ IU FIX). Eight rats were tested at each dose level in the presence or absence of heparin, considering those samples with a thrombogenicity ≥2.0 as of potential thrombogenic risk. The mean scores ± SD 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. At both doses tested of FIXpd in the absence of heparin, there was no significant difference in mean scores (P<0.05). The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderivados.
publishDate 2021
dc.date.none.fl_str_mv 2021-05
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/183618
Martinez, M. C.; Rodriguez, R.; Marinsaldi, Melisa Anahi; Rodriguez, G. R.; Guglielmone, Hugo; et al.; Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina; Austin Publishing Group ; Annals of hematology and oncology; 8; 5; 5-2021; 1343-1345
2375-7965
CONICET Digital
CONICET
url http://hdl.handle.net/11336/183618
identifier_str_mv Martinez, M. C.; Rodriguez, R.; Marinsaldi, Melisa Anahi; Rodriguez, G. R.; Guglielmone, Hugo; et al.; Assessment of potential thrombogenicity in an animal model of a triple viral inactivated Factor IX Concentrate Manufactured in Argentina; Austin Publishing Group ; Annals of hematology and oncology; 8; 5; 5-2021; 1343-1345
2375-7965
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://austinpublishinggroup.com/hematology/fulltext/hematology-v8-id1343.php
info:eu-repo/semantics/altIdentifier/doi/10.26420/annhematoloncol.2021.1343
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Austin Publishing Group
publisher.none.fl_str_mv Austin Publishing Group
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1846781450762846208
score 12.982451

Publicaciones similares