VISICORT clinical trial takes its first steps

VISICORT celebrates its first validation shipment of Stromal Cells from CCMI Galway to Charité Research Organisation (CRO) in Berlin for the commencement of the VISICORT clinical trial.

In the pictures below, Aoife Duffy, Manufacturing Manager at Centre for Cell Manufacturing Ireland (CCMI) at the National University of Ireland Galway is holding the first cell shipment. Cells were manufactured by CCMI in Galway and transport was performed by Biostór Ireland – a “Known Shipper” with the Irish Aviation Authority (IAA). This is the first of 7 shipments to be carried out during 2018 to establish the safety and tolerability of two intravenous infusions of allogeneic human bone marrow-derived mesenchymal stromal cells (allogenic-BM-MSC) and evaluate the potential efficacy of pre-transplant intravenous infusions of allogenic-BM-MSC to reduce the risk of acute rejection of corneal re-transplants.

As a Known Consignor, Biostór can ship cells without the use of X-ray scans. All air cargo and truck shipments are now subject to X-Ray scan. X-rays would be hazardous to the MSCs. Becoming “Known” involved Garda Vetting, the completion of a 1-day of Aviation Security Training course, writing a comprehensive Air Cargo Security Manual and SOPs, and a site audit by IAA.

Biostór’s Peadar MacGabhann comments, “Becoming a Known Consignor with the IAA was worth it and ensures that Biostór can support future VISICORT cell therapy trials and ensure the project reaches the conclusions that were planned at the outset. how this will impact the project.”

Feature image photo credit: Wellcome Collection with a Creative Commons 4.0 International license