Logistics of an advanced therapy medicinal product during COVID-19 pandemic in Italy: successful delivery of mesenchymal
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Journal of Translational Medicine Open Access
RESEARCH
Logistics of an advanced therapy medicinal product during COVID‑19 pandemic in Italy: successful delivery of mesenchymal stromal cells in dry ice Giuseppe Astori1* , Martina Bernardi1,2, Angela Bozza1,2, Daniela Catanzaro1,2, Katia Chieregato1,2, Anna Merlo1, Monica Santimaria3, Roberto Barbazza4, Giuseppe Amodeo5, Rachele Ciccocioppo5, Francesca Elice6 and Marco Ruggeri6
Abstract 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. Keywords: COVID-19, GvHD, Mesenchymal stromal cells, Supply chain Background Advanced therapy medicinal products (ATMPs), including stem cells, are usually stored and cryopreserved in liquid nitrogen (LN2) and delivered to points-of-care by authorized couriers using dry vapour (dewar) shippers. This enables the direct transport of ATMPs to *Correspondence: [email protected] 1 Advanced Cellular Therapy Laboratory, Haematology Unit, Vicenza Hospital, Contrà S. Francesco, 41, 36100 Vicenza (I), Italy Full list of author information is available at the end of the article
points-of-care, where they are thawed and infused at the bedside, primarily because hospital pharmacy services do not have access to L N2 freezers. Moreover, vapour-phase shipment requires not only specific logistical resources, but also strict adherence to handling procedures for L N2 supplies by trained personnel [1]. During the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, Italian hospitals faced the most daunting challenges of our recent history. In this context, the capability to provide ATMPs was impeded by the urgent need to
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