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    Inicio > Historias > Actualización de la información sobre Evaluaciones de Riesgo Medioambiental del Ministerio de transición ecológica 2019-06-20

    Actualización de la información sobre Evaluaciones de Riesgo Medioambiental del Ministerio de transición ecológica

    El pasado mes de noviembre de 2018 publicábamos una, tal vez pretenciosa, entrada sobre ¿Quién, donde y en qué se investiga en España en ATMP´s? Somos conscientes de que no se recoge aquí toda la investigación en ATMP´s en España sino una aproximación en lo referente al uso de OMG´s con finalidad de llevar a cabo ensayos clínicos para conseguir la autorización de ATMP´s.

    Posteriormente publicamos Notificaciones de liberación de OMG´s  por institución  y en el mes de marzo de 2019 publicábamos otra entrada sobre Actualización de los ERMA´s del MITECO. Hemos trabajado los datos obtenidos en marzo y presentamos los datos agregados que se obtiene.

    Hay que decir que no hay más Evaluaciones de Riesgo Medioambiental (ERMA´s)  publicadas en la página web del Ministerio de transición ecológica (MITECO) que las vistas en el mes de marzo y sí hay más Notificaciones  de liberaciones voluntarias.


    El esquema es el mismo seguido en la publicación de noviembre:

    Número de ERMA´s por año.

    Podemos ver el importante incremento que se produce en 2017 y 2018, que no entendemos por qué no continua en 2019 y tal vez tenga que ver con la no necesidad de una nueva evaluación de riesgo el uso de un medicamento ya autorizado, es decir autorización de comercialización por la EMA. No obstante el año asignado corresponde al de la solicitud de la valuación del riesgo, por lo que podrían producirse a lo largo del año 2019 las evaluaciones de lo solicitado en el año, como corresponde.


    año

    NUM

    2018

    23

    2017

    14

    2016

    8

    2015

    9

    2014

    4

    2013

    3

    2012

    9

    2011

    3

    2010

    1

    2009

    1

    2008

    3

    2006

    1



    ¿Qué riesgos son los evaluados?

    Hemos homogeneizado las denominaciones para no clasificar como diferente lo que es igual y diferenciado en vacunas lo que serían vacunas contra virus de los que son vacunas contra tumores, que los identificamos con un (*). Una vacuna contra el Parkinson corresponde a  (**). Presentamos el número de ERMA´s por riesgo.


    Riesgo evaluado

    NUM

    CÉLULAS T MODIFICADAS GENÉTICAMENTE

    15

    VIRUS ADENOASOCIADOS MODIFICADOS GENÉTICAMENTE

    11

    ADENOVIRUS MODIFICADOS GENÉTICAMENTE

    10

    HERPESVIRUS SIMPLE DE TIPO 1 MODIFICADO GENÉTICAMENTE

    8

    VACUNA MODIFICADA GENETICAMENTE(*)

    6

    CÉLULAS MODIFICADAS GENÉTICAMENTE

    4

    VACUNA MODIFICADA GENETICAMENTE

    4

    UN VIRUS ADENOASOCIADO MODIFICADO GENÉTICAMENTE

    3

    VIRUS VACCINIA MODIFICADO GENÉTICAMENTE

    3

    CÉLULAS CD34+ MODIFICADAS GENÉTICAMENTE

    2

    LISTERIA MONOCYTOGENES MODIFICADA GENÉTICAMENTE

    2

    VIRUS VACCINIA Y ADENOVIRUS MODIFICADOS GENÉTICAMENTE

    2

    VECTOR DE TERAPIA GÉNICA MODIFICADO GENÉTICAMENTE

    2

    VACUNA MODIFICADA GENETICAMENTE(**)

    1

    DOS VIRUS MODIFICADOS GENÉTICAMENTE

    1

    CITOMEGALOVIRUS MODIFICADOS GENÉTICAMENTE

    1

    CÉLULAS T ALOGÉNICAS MODIFICADAS GENÉTICAMENTE

    1

    VIRUS DE LA ESTOMATITIS VESICULAR (VSV) MODIFICADO GENÉTICAMENTE (VACUNA BPSC-1001/rVSV∆G-ZEBOV GP/V920)

    1

    VIRUS DEL HERPES SIMPLE TIPO 1 MODIFICADOS GENÉTICAMENTE

    1

    LINFOCITOS AUTÓLOGOS MODIFICADOS GENÉTICAMENTE

    1


     Centros de investigación:

    al menos 70 centros participan en los ensayos clínicos. En su inmensa mayoría son hospitales, Hay un total de 198 participaciones, entendidas como cada uno de los centros que participan el los diversos ensayos. En 4 estudios,- que aparecen los dos primeros y los dos últimos en el listado de abajo -, no se dice en qué centros se lleva a cabo el ensayo clínico. Los centros con más participaciones y el porcentaje de su participación sobre el total son:



    Centro

    Particip.

    Porcentaje

    Hospital Clínic de Barcelona

    17

    8,6%


    Clínica Universidad de Navarra

    14

    7,1%

    Hospital Universitario 12 de Octubre

    14

    7,1%


    Estos tres hospitales representan el 22,8% de las participaciones de centros en los ensayos clínicos.



    Hospital participante

    NUM

    11 centros hospitalarios europeos


    14 centros sanitarios en España en los que se administran vacunas pediátricas con frecuencia.


    Área de Vacunas del Centro de Investigación en Salud Pública de Valencia

    1

    Centro Integral Oncológico Clara Campal (CIOCC) - Hospital Universitario HM
    Sanchinarro

    1

    Clínica Universidad de Navarra

    14

    Complejo Asistencial Universitario de Salamanca

    1

    Complejo Hospitalario de Jaén

    1

    Complejo Hospitalario Regional de Málaga

    3

    Complejo Hospitalario Regional Virgen Macarena

    1

    Complejo Hospitalario Universitario de Santiago

    1

    Complexo Hospitalario Universitario de Ourense

    2

    Corporació Sanitària Parc Taulí de Sabadell

    2

    Fundación Estudio Hepatitis Virales de Madrid

    1

    Fundación Instituto Valenciano de Oncología (IVO)

    1

    Fundación Oncologikoa Fundatzioa

    1

    Hospital de Fuenlabrada

    1

    Hospital Clínic de Barcelona

    17

    Hospital Clínico San Carlos

    1

    Hospital Clínico Universitario de Santiago

    2

    Hospital Clínico universitario de Valencia

    2

    Hospital Clínico Universitario Lozano Blesa

    1

    Hospital Clínico Universitario Virgen de la Arrixaca

    1

    Hospital de la Santa Creu i Sant Pau

    3

    Hospital de Navarra

    1

    Hospital de Nuestra Señora de Valme en Sevilla

    1

    Hospital de Santiago de Compostela

    1

    Hospital del Mar de Barcelona

    1

    Hospital General Universitario de Elche

    2

    Hospital General Universitario de Valencia

    4

    Hospital General Universitario Gregorio Marañón

    4

    Hospital HM Universitario Sanchinarro (CIOCC)

    1

    Hospital Infantil Universitario Niño Jesús

    7

    Hospital Marqués de Valdecilla

    1

    Hospital Ramón y Cajal

    1

    Hospital Regional Universitario de Málaga

    1

    Hospital Sant Joan de Déu de Barcelona

    7

    Hospital Sant Rafael (Germanes Hospitalaries)

    1

    Hospital Severo Ochoa

    1

    Hospital Son Llatzer de Palma de Mallorca

    2

    Hospital Teresa Herrera

    2

    Hospital Univeristari Vall d´Hebron

    8

    Hospital Univeristario La Paz

    1

    Hospital Universitari Germans Trias i Pujol (Badalona)

    9

    Hospital Universitari i Politecnic La Fe

    3

    Hospital Universitari Quirón Dexeus de Barcelona

    1

    Hospital Universitario 12 de Octubre

    14

    Hospital Universitario Central de Asturias

    2

    Hospital Universitario Cruces de Vizcaya

    5

    Hospital Universitario de Bellvitge

    2

    Hospital Universitario de la Princesa de Madrid

    1

    Hospital Universitario de Málaga

    1

    Hospital Universitario de Móstoles de Madrid

    1

    Hospital Universitario de Salamanca

    2

    Hospital Universitario Fundación Jiménez Díaz

    6

    Hospital Universitario Gregorio Marañón

    1

    Hospital Universitario HM Sanchinarro

    1

    Hospital Universitario La Paz

    10

    Hospital Universitario Madrid Sanchinarro

    5

    Hospital Universitario Quirón Dexeus

    1

    Hospital Universitario Ramón y Cajal

    3

    Hospital Universitario Reina Sofía

    1

    Hospital Universitario Son Espases

    1

    Hospital Universitario Virgen de la Victoria

    1

    Hospital Universitario Virgen del Rocío

    6

    Institut Catalá de Oncología Hospital Duran i Reynals

    9

    Institut Català d'Oncologia (ICO) de Girona

    1

    Instituto de Investigación Sanitaria Fundación Jiménez Díaz

    1

    Instituto Valenciano de Oncología

    1

    Tan pronto ...como el notificador conozca los hospitales españoles que van a participar en ese estudio deberá comunicarlo a la Comisión Nacional de Bioseguridad (CNB)


    varios hospitales españoles…



    En los datos agregados por Comunidad Autónoma podemos ver el predominio de Cataluña (63) y Madrid (62) en el tema. Los 4 sin comunidad corresponden a los mencionados en Centros de investigación sin identificar..



    CCAA

    NUM 

    Madrid

    63

    Cataluña

    62

    Navarra

    15

    Andalucia

    15

    Comunidad Valenciana

    14

    Galicia

    8

    País Vasco

    6


    4

    Castilla-León

    3

    Baleares

    3

    Asturias

    2

    Murcia

    1

    Cantabria

    1

    Aragón

    1






    Indicaciones.

    Las indicaciones,  para las que se ha construido estos medicamentos se pueden agrupar por mayor ó menor detalle. Los diversos tipos de cáncer son la gran mayoría de las dianas (53),  vacunas contra enfermedades infecciosas (5), con algunos  antiinfecciosos (6), hematológicos (6), metabólicos, (5), problemas neurológicos (3) .



    Grupos indicaciones

    NUM

    cáncer

    53

    hematológico

    6

    infeccioso

    6

    inmunodeficiencia

    1

    metábolico

    5

    neurológico

    3

    vacunas

    5


    Presentamos la lista de las  54 indicaciones en la siguiente tabla


    indicación 

    NUM

    adenocarcinoma renal

    1

    adultos con glucogenosis de tipo Ia (GSD-Ia)

    1

    Anemia Fanconi

    1

    atrofia espinal presintomática diagnosticada genéticamente

    1

    Cáncer colorrectal

    1

    cáncer de prostata

    1

    cancer pancreas

    1

    cáncer piel

    1

    cáncer pulmón

    1

    Cáncer SNC

    1

    cáncer útero

    1

    carcinoma avanzado de tubo digestivo

    1

    carcinoma colorrectal

    1

    carcinoma de células escamosas de cabeza y cuello

    1

    CPNM

    3

    deficit LAD-I

    1

    deficit OTC

    1

    deficit PQE

    1

    Glioblastoma

    3

    gliomas

    1

    Hemofilia

    2

    Hepatitis C

    2

    hepatocarcinoma

    3

    leucemia linfoblástica aguda B (LLAB)

    1

    linfoma folicular en recaída/refractario

    1

    linfoma no Hodgkin (LNH) de células B

    1

    LLA

    3

    LLA con transplante haploidéntico

    1

    LLA-B

    2

    LLA-B y LNH-B

    1

    LNH-B

    3

    Melanoma

    4

    MM

    2

    MPS III tipo A

    1

    MPS III tipo B

    2

    neoplasia intraepitelial

    1

    pacientes adultos con linfoma no Hodgkin de células B agresivo

    1

    pacientes con cáncer de mama residual tras quimioterapia neoadyuvante

    1

    pacientes con hemofilia A

    2

    pacientes con mieloma múltiple en recaída y refractario y en pacientes con mieloma múltiple de alto riesgo

    1

    pacientes pediátricos con leucemia linfoblástica aguda de células B

    1

    pacientes VIH-1 positivos tratados de forma precoz

    2

    PAI

    1

    Parkinson

    1

    sujetos afectados con neuropatía óptica hereditaria de Leber G11778A ND4

    1

    tumores epiteliales avanzado

    1

    tumores hepáticos

    1

    Tumores sólidos

    4

    vacuna CMV

    1

    Vacuna Ebola

    1

    vacuna VIH

    2

    VACUNA VRS

    2

    VIH

    2


    Con respecto a los Laboratorios promotores de las liberaciones, en algunas de ellas No Vemos la Empresa responsable (NVE),


    NUM

    Laboratorio

    2

    Abeona Therapeutics Inc.

    3

    Adaptimmune LLC

    3

    Aelix Therapeutics

    7

    Amgen Limited, UK

    1

    AveXis Inc

    1

    Bavarian Nordic

    1

    BAXALTA INNOVATIONS

    1

    Bayer

    1

    Bellicum Pharmaceutical Inc

    2

    Bio Marin Pharmaceutical Inc.

    1

    Bristol-Myers Squibb S.A.

    6

    Celgene Corporation

    1

    CIEMAT

    1

    Clínica Universitaria de Navarra

    2

    CLINISTEM

    1

    Digna Biotech

    1

    Dimension Therapeutics, Inc,

    2

    FIBHNJS

    1

    GenSight Biologics

    1

    GSK

    1

    Institut Català d’Oncologia

    3

    IrsiCaixa

    1

    Janssen-Cilag International

    1

    Kite Pharma

    1

    Laboratorios Esteve

    1

    Laboratorios Servier S.L.

    1

    MedImune

    2

    Merck Sharp&Dohme

    1

    MolMed Spa

    2

    Novartis

    4

    Novartis Farmacéutica S.A.

    2

    NVE

    4

    NVE ¿CUN?

    1

    NVE ¿Novartis?

    1

    Parexel Internacional, S.L,

    1

    Quintiles Limited

    1

    Roche

    1

    Sanofi Aventis

    1

    Solti

    1

    Theradex

    3

    Transgene, S.A.

    1

    Ultragenyx Pharmaceutical, Inc.

    2

    VCN Biosciences

    3

    Voisin Consulting


    2019-06-20 16:20 | 27 Comentarios


    Referencias (TrackBacks)

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