1. Safety profile of autologous macrophage therapy for liver cirrhosis
- Author
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Moroni, Francesca, Dwyer, Benjamin J., Graham, Catriona, Pass, Chloe, Bailey, Laura, Ritchie, Lisa, Mitchell, Donna, Glover, Alison, Laurie, Audrey, Doig, Stuart, Hargreaves, Emily, Fraser, Alasdair R., Turner, Marc L., Campbell, John D. M., McGowan, Neil W. A., Barry, Jacqueline, Moore, Joanna K., Hayes, Peter C., Leeming, Diana J., Nielsen, Mette J., Musa, Kishwar, Fallowfield, Jonathan A., and Forbes, Stuart J.
- Abstract
Therapies to reduce liver fibrosis and stimulate organ regeneration are urgently needed. We conducted a first-in-human, phase 1 dose-escalation trial of autologous macrophage therapy in nine adults with cirrhosis and a Model for End-Stage Liver Disease (MELD) score of 10–16 (ISRCTN 10368050). Groups of three participants received a single peripheral infusion of 107, 108or up to 109cells. Leukapheresis and macrophage infusion were well tolerated with no transfusion reactions, dose-limiting toxicities or macrophage activation syndrome. All participants were alive and transplant-free at one year, with only one clinical event recorded, the occurrence of minimal ascites. The primary outcomes of safety and feasibility were met. This study informs and provides a rationale for efficacy studies in cirrhosis and other fibrotic diseases.
- Published
- 2019
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