DC FieldValueLanguage
dc.contributor.authorGoula, Aspasia-
dc.contributor.authorKatsimpoulas, Michalis-
dc.contributor.authorMichalopoulos, Efstathios-
dc.contributor.authorKostakis, Alkiviadis-
dc.contributor.authorGkioka, Vasiliki-
dc.contributor.authorSarri, Eirini Faidra-
dc.contributor.authorStavropoulos-Giokas, Catherine-
dc.contributor.authorNoutsias, Michel-
dc.date.accessioned2024-04-25T09:38:56Z-
dc.date.available2024-04-25T09:38:56Z-
dc.date.issued2020-01-01-
dc.identifierscopus-85104441329-
dc.identifier.issn1918-3011-
dc.identifier.issn1918-3003-
dc.identifier.other85104441329-
dc.identifier.urihttps://uniwacris.uniwa.gr/handle/3000/2266-
dc.description.abstractRecently, the design and development of a modern health policy in the field of regenerative medicine leads to the formation of a new and integrated cognitive field, which requires systematic research and study in order to produce innovative answers and best practices. Advanced therapy medicinal products (ATMPs) is a new product category, which is at the heart of concern since it has to deal with diseases in which traditional medicine has proven to be ineffective so far. The aim of this review is to provide evidence for the state of the art ATMPs and their modern applications in the field of regenerative medicine. The ATMPs are characterized by a great heterogeneity and variation in methods of isolation, which cover the entire spectrum from a single intravenous injection to a surgical placement. Clinical development of ATMP encounters specific challenges due to the nature of the product and the limited availability of non-clinical data. The gold standard of a controlled, randomized, clinical trial may not be feasible or ethically justified for all indications, particularly in life-threatening diseases, where there is no satisfactory standard of care. Therefore, the European Commission (EC) took initiatives in order to set standards and operating rules concerning authorization and supervision of ATMPs and on pharmacovigilance in relation to them. The European Union (EU) Regulation 1394/2007 provides the possibility of exceptions. In particular, the “hospital exemption” allows for the administration of an ATMP without a license on certain conditions. Although the Regulation 1394/2007 has led to the commercial exploitation of ATMPs, the reality today, 11 years after its first implementation, is completely different. While the Committee for Advanced Therapies (CAT) has already registered 285 products as ATMPs, only 10 licenses were granted which only remained six (the rest related to products withdrawn). The key players in the development and delivery of ATMPs still remain the academic/research centers and small and medium-sized enterprises; while the involvement of pharmaceutical companies is focusing on recent developments in the treatment of oncological incidents with in vitro modified cytotoxic T lymphocytes, and chimeric antigen receptor (CAR)-T cells.en_US
dc.language.isoenen_US
dc.relation.ispartofJournal of Clinical Medicine Researchen_US
dc.subjectAdvanced therapy medicinal productsen_US
dc.subjectCATen_US
dc.subjectEU regulationen_US
dc.subjectQuality and safety standardsen_US
dc.subjectRandomize clinical trialen_US
dc.titleAdvanced Therapy Medicinal Products Challenges and Perspectives in Regenerative Medicineen_US
dc.typeArticleen_US
dc.identifier.doi10.14740/jocmr3964en_US
dc.identifier.scopus2-s2.0-85104441329-
dcterms.accessRights1en_US
dc.relation.deptDepartment of Business Administrationen_US
dc.relation.facultySchool of Administrative, Economics and Social Sciencesen_US
dc.relation.volume12en_US
dc.relation.issue12en_US
dc.identifier.spage780en_US
dc.identifier.epage786en_US
dc.collaborationUniversity of West Attica (UNIWA)en_US
dc.journalsOpen Accessen_US
dc.publicationPeer Revieweden_US
dc.countryGreeceen_US
local.metadatastatusverifieden_US
item.grantfulltextnone-
item.cerifentitytypePublications-
item.openairetypeArticle-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.languageiso639-1en-
crisitem.author.deptDepartment of Business Administration-
crisitem.author.facultySchool of Administrative, Economics and Social Sciences-
crisitem.author.orcid0000-0003-4246-9627-
crisitem.author.parentorgSchool of Administrative, Economics and Social Sciences-
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