{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T12:32:54Z","timestamp":1793795574790,"version":"4.6.1"},"reference-count":19,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:00:00Z","timestamp":1752710400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:00:00Z","timestamp":1752710400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Following the approval of the first gene therapies for haemophilia, it is essential to develop an optimal infrastructure for the administration of gene therapy. This can be ensured by identifying the criteria for the definition of treatment centres (hub centres) and follow\u2010up centres (spoke centres), as well as establishing effective cooperation between them.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The interdisciplinary members of the EAHAD Gene Therapy Working Group answered a survey to define requirements for centres participating in gene therapy care, addressing aspects such as product administration, coagulation parameter monitoring, and long\u2010term safety surveillance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The majority support the implementation of standardised protocols. Hub centres are expected to maintain high standards of quality and flexibility, possess pharmacist expertise, ensure regulatory compliance, and have experience in gene therapy Spoke centres should be certified haemophilia centres, access to hepatologists and providing 24\u2010h support. Prior to gene therapy, spoke centres manage initial patient interactions, while hub centres handle complex care needs. Post\u2010therapy, both centres can monitor factor levels and liver health. However, hub centres are responsible for managing immunosuppression and facilitating specialist consultations. Collaboration between both centres is crucial for data sharing and the assessment and resolution of adverse events, emphasising the importance of timely test results and regular liver imaging.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The survey results highlight essential criteria for the safe and effective delivery of gene therapy through a structured hub\u2010and\u2010spoke model. These include accreditation, clinical trial experience, access to specialized healthcare professionals, and the establishment of standard operating procedures for monitoring and managing adverse events.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70090","type":"journal-article","created":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T17:40:03Z","timestamp":1752774003000},"page":"966-972","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Qualification Criteria of Gene Therapy for Haemophilia\u2014Opinion of the EAHAD Gene Therapy Working Group"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4506-0061","authenticated-orcid":false,"given":"Wolfgang","family":"Miesbach","sequence":"first","affiliation":[{"name":"Medical Clinic 2 Institute of Transfusion Medicine University Hospital Frankfurt  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3532-2336","authenticated-orcid":false,"given":"Ana","family":"Boban","sequence":"additional","affiliation":[{"name":"Haemophilia Centre Department of Haematology University Hospital Centre Zagreb  Zagreb Croatia"},{"name":"University of Zagreb School of Medicine  Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0135-1051","authenticated-orcid":false,"given":"Pratima","family":"Chowdary","sequence":"additional","affiliation":[{"name":"Katharine Dormandy Haemophilia and Thrombosis Centre Royal Free Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiel","family":"Coppens","sequence":"additional","affiliation":[{"name":"Hemophilia Treatment Center Department of Vascular Medicine Amsterdam UMC location University of Amsterdam  Amsterdam Netherlands"},{"name":"Amsterdam Cardiovascular Sciences Pulmonary Hypertension &amp; Thrombosis  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3937-3499","authenticated-orcid":false,"given":"Victor","family":"Jimenez\u2010Yuste","sequence":"additional","affiliation":[{"name":"Hematology Department Hospital Universitario La Paz\u2010IdiPaz Autonoma University  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4194-8183","authenticated-orcid":false,"given":"Robert","family":"Klamroth","sequence":"additional","affiliation":[{"name":"Department for Internal Medicine and Vascular Medicine Haemophilia Treatment Center Vivantes Hospital im Friedrichshain  Berlin Germany"},{"name":"Institute of Experimental Hematology and Transfusion Medicine University Hospital Bonn Medical Faculty University of Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2278-3459","authenticated-orcid":false,"given":"Greta","family":"Mulders","sequence":"additional","affiliation":[{"name":"Department of Hematology Erasmus University Medical Center  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Crato","sequence":"additional","affiliation":[{"name":"European Haemopilia Consortium  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7423-9864","authenticated-orcid":false,"given":"Flora","family":"Peyvandi","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa  Milan Italy"},{"name":"Department of Pathophysiology and Transplantation Universit\u00e0 degli Studi di Milano  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14308"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14309"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14887"},{"issue":"3","key":"e_1_2_10_5_1","first-page":"s525","article-title":"The European Standards of Haemophilia Centres","volume":"12","author":"Giangrande P.","year":"2014","journal-title":"Blood Transfusion"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14420"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14546"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14709"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2024.07.029"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.15125"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100042\u20101760262"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14908"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2024.109180"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2023.10.029"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019003777"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2024.102673"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/rth2.12326"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14512"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14985"},{"key":"e_1_2_10_20_1","unstructured":"National Bleeding Disorders Foundation MASAC Recommendations on Hemophilia Treatment Center Preparedness for Delivering Gene Therapy for Hemophilia. 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