TY - JOUR
T1 - Developing cell therapies as drug products
AU - Ciccocioppo, Rachele
AU - Comoli, Patrizia
AU - Astori, Giuseppe
AU - del Bufalo, Francesca
AU - Prapa, Malvina
AU - Dominici, Massimo
AU - Locatelli, Franco
N1 - Funding Information:
This work was partially supported by the following research grants: Ricerca Corrente 08069113, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo and a grant from the Fondazione Just ? Soleterre Onlus, to P.C.; Associazione Vicentina per le Leucemie ed i Linfomi-Associazione Italiana Leucemie (AVILL-AIL) to G.A; My First AIRC ? ID 20450 to F.D.B.; Associazione Italiana Ricerca Cancro (AIRC) IG 2012 and IG 2015 Grants #12755 and #17326, the Associations ASEOP and ASLEM and Project ?Dipartimenti Eccellenti MIUR 2017? to M.D.; Fondazione AIRC Special Program Metastatic disease: the key unmet need in Oncology 5 per mille 2018 Project Code 21147 and Accelerator Award 2017 INCAR, Ministero dell'Istruzione, dell'Universit? e della Ricerca, PRIN ID 2017 WC8499_004 and Ministero della Salute, RF-2016-02364388 to F.L. These sources of funding were not in any way involved in the study design, collection and interpretation of data, writing of the manuscript, or in the decision to submit the article for publication.
Publisher Copyright:
© 2020 The British Pharmacological Society
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - In the last 20 years, the global regulatory frameworks for drug assessment have been managing the challenges posed by using cellular products as new therapeutic tools. Currently, they are defined as “Advanced Therapy Medicinal Products”, comprising a large group of cellular types that either alone or in combination with gene and tissue engineering technology. They have the potential to change the natural course of still lethal or highly debilitating diseases, including cancers, opportunistic infections and chronic inflammatory conditions. Globally, more than 50 cell-based products have obtained market authorization. This overview describes the advantages and unsolved challenges on developing cells as innovative therapeutic vehicles. The main cell therapy players and the legal framework are discussed, starting from chimeric antigen receptor T-cells for leukaemia and solid tumours, dealing then with lymphocytes as potent anti-microbiological tools and then focusing on mesenchymal stem/stromal cells whose role covers regenerative medicine, immunology and anti-tumour therapy.
AB - In the last 20 years, the global regulatory frameworks for drug assessment have been managing the challenges posed by using cellular products as new therapeutic tools. Currently, they are defined as “Advanced Therapy Medicinal Products”, comprising a large group of cellular types that either alone or in combination with gene and tissue engineering technology. They have the potential to change the natural course of still lethal or highly debilitating diseases, including cancers, opportunistic infections and chronic inflammatory conditions. Globally, more than 50 cell-based products have obtained market authorization. This overview describes the advantages and unsolved challenges on developing cells as innovative therapeutic vehicles. The main cell therapy players and the legal framework are discussed, starting from chimeric antigen receptor T-cells for leukaemia and solid tumours, dealing then with lymphocytes as potent anti-microbiological tools and then focusing on mesenchymal stem/stromal cells whose role covers regenerative medicine, immunology and anti-tumour therapy.
KW - chronic inflammatory diseases
KW - clinical trials
KW - haematological malignancies
KW - immune tolerance
KW - mesenchymal stem/stromal cells
KW - opportunistic infections
KW - solid tumours
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U2 - 10.1111/bph.15305
DO - 10.1111/bph.15305
M3 - Review article
C2 - 33140850
AN - SCOPUS:85097271828
VL - 178
SP - 262
EP - 279
JO - British Journal of Pharmacology
JF - British Journal of Pharmacology
SN - 0007-1188
IS - 2
ER -