Logistics of an advanced therapy medicinal product during COVID-19 pandemic in Italy: successful delivery of mesenchymal stromal cells in dry ice.
Acute Disease
COVID-19
/ epidemiology
Cell Proliferation
Cell Survival
Cells, Cultured
Cord Blood Stem Cell Transplantation
/ adverse effects
Delivery of Health Care
/ organization & administration
Dry Ice
Equipment and Supplies, Hospital
/ standards
Graft vs Host Disease
/ etiology
Humans
Italy
/ epidemiology
Materials Management, Hospital
/ organization & administration
Mesenchymal Stem Cell Transplantation
/ methods
Mesenchymal Stem Cells
/ cytology
Organization and Administration
/ standards
Pandemics
Phenotype
Point-of-Care Systems
/ organization & administration
SARS-CoV-2
/ physiology
Severity of Illness Index
Transportation
/ methods
COVID-19
GvHD
Mesenchymal stromal cells
Supply chain
Journal
Journal of translational medicine
ISSN: 1479-5876
Titre abrégé: J Transl Med
Pays: England
ID NLM: 101190741
Informations de publication
Date de publication:
30 11 2020
30 11 2020
Historique:
received:
04
08
2020
accepted:
18
11
2020
entrez:
1
12
2020
pubmed:
2
12
2020
medline:
22
12
2020
Statut:
epublish
Résumé
During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft-versus-host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option. We assessed effects of the transition from liquid nitrogen to dry ice on cell viability; apoptosis; phenotype; proliferation; immunomodulation; and clonogenesis; and validated dry ice-based transport of UC-MSCs to clinics. Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes. This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.
Sections du résumé
BACKGROUND
During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft-versus-host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option.
METHODS
We assessed effects of the transition from liquid nitrogen to dry ice on cell viability; apoptosis; phenotype; proliferation; immunomodulation; and clonogenesis; and validated dry ice-based transport of UC-MSCs to clinics.
RESULTS
Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes.
CONCLUSIONS
This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.
Identifiants
pubmed: 33256746
doi: 10.1186/s12967-020-02625-0
pii: 10.1186/s12967-020-02625-0
pmc: PMC7702210
doi:
Substances chimiques
Dry Ice
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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