Macrophage Therapy for Acute Liver Injury (MAIL): a Phase 1 Randomised, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Activity of Allogeneic Alternatively Activated Macrophages in Patients with Paracetamol-induced Acute Liver Injury
Christopher Humphries, Melisande Addison, Guruprasad Aithal, Julia Boyd, Lesley Briody, John DM Campbell, Maria Elena Candela, Ellise Clarke, James Coulson, Nicholas Downing-James, Robert John Fontana, Ailsa Geddes, Julia Grahamslaw, Alison Grant, Anna Heye, James A Hutchinson, Ashley Jones, Fiona Mitchell, Joanna Moore, Alice Riddell, Aryelly Rodriguez, Angela Thomas, Garry Tucker, Kim Walker, Christopher J Weir, Rachel Woods, Sharon Zahra, Stuart J Forbes, James Dear
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Abstract
Introduction Acute Liver Failure (ALF) has no effective treatment other than liver transplantation, and is commonly caused by paracetamol overdose. New treatments are needed to treat and prevent ALF. Alternatively activated macrophages (AAMs) can promote resolution of liver necrosis and stimulate hepatocyte proliferation. Using AAMs in unscheduled care requires the use of an allogeneic product. A clinical trial is needed to determine the safety and tolerability of allogeneic AAMs.
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