TY - JOUR
T1 - Recycling Apparent Waste Into Biologicals
T2 - The Case of Umbilical Cord Blood in Italy and Spain
AU - Rebulla, Paolo
AU - Querol, Sergio
AU - Pupella, Simonetta
AU - Prati, Daniele
AU - Delgadillo, Joaquin
AU - De Angelis, Vincenzo
N1 - Funding Information:
Grant ?Ricerca Corrente 2020?, Foundation IRCCS Ca? Granda Ospedale Maggiore Policlinico, Milan, Italy.
Publisher Copyright:
Copyright © 2022 Rebulla, Querol, Pupella, Prati, Delgadillo and De Angelis.
PY - 2022/1/4
Y1 - 2022/1/4
N2 - Most public cord blood banking programs are currently facing financial difficulties due to a progressive decline in the number of cord blood transplants performed worldwide and to a high discard rate of the donated units caused by progressively increasing thresholds of the stem cell dose required to perform safe and effective hemopoietic cord blood transplants. Recycling a proportion of unused cord blood units to prepare novel cord blood components obtained with minimal manipulation (platelets, plasma, red blood cells) and to develop more technologically complex products regulated in the US as Cellular and Gene Therapy Products and in Europe as Advanced Therapy Medicinal Products [e.g. virus-specific T cells (VST), natural killer (NK) cells, induced pluripotent stem cells (iPSCs) is a promising strategy to increase the therapeutic value and reduce the financial deficits of public cord blood banking. Based on encouraging preliminary evidences reported in the literature, additional laboratory studies, large multicenter clinical trials and international regulatory harmonization are necessary to achieve these important goals. This article describes organizational, methodological and regulatory advancements developed in Italy and Spain to promote the clinical use of cord blood platelets, plasma and red blood cells.
AB - Most public cord blood banking programs are currently facing financial difficulties due to a progressive decline in the number of cord blood transplants performed worldwide and to a high discard rate of the donated units caused by progressively increasing thresholds of the stem cell dose required to perform safe and effective hemopoietic cord blood transplants. Recycling a proportion of unused cord blood units to prepare novel cord blood components obtained with minimal manipulation (platelets, plasma, red blood cells) and to develop more technologically complex products regulated in the US as Cellular and Gene Therapy Products and in Europe as Advanced Therapy Medicinal Products [e.g. virus-specific T cells (VST), natural killer (NK) cells, induced pluripotent stem cells (iPSCs) is a promising strategy to increase the therapeutic value and reduce the financial deficits of public cord blood banking. Based on encouraging preliminary evidences reported in the literature, additional laboratory studies, large multicenter clinical trials and international regulatory harmonization are necessary to achieve these important goals. This article describes organizational, methodological and regulatory advancements developed in Italy and Spain to promote the clinical use of cord blood platelets, plasma and red blood cells.
KW - biologics
KW - eye drops
KW - neonatal transfusion
KW - platelet gel
KW - platelets
KW - umbilical cord blood
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UR - http://www.scopus.com/inward/citedby.url?scp=85123800257&partnerID=8YFLogxK
U2 - 10.3389/fcell.2021.812038
DO - 10.3389/fcell.2021.812038
M3 - Article
AN - SCOPUS:85123800257
SN - 2296-634X
VL - 9
JO - Frontiers in Cell and Developmental Biology
JF - Frontiers in Cell and Developmental Biology
M1 - 812038
ER -