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Safety profile of autologous macrophage therapy for liver cirrhosis

Research output: Contribution to journalArticlepeer-review

  • Catriona Graham
  • Chloe Pass
  • Laura Bailey
  • Lisa Ritchie
  • Donna Mitchell
  • Alison Glover
  • Audrey Laurie
  • Stuart Doig
  • Emily Hargreaves
  • Alasdair R Fraser
  • Marc L Turner
  • John D M Campbell
  • Neil W A McGowan
  • Jacqueline Barry
  • Diana J Leeming
  • Mette J Nielsen
  • Kishwar Musa

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Original languageEnglish
Pages (from-to)1560–1565
Number of pages6
JournalNature Medicine
Volume25
Issue number10
Early online date7 Oct 2019
DOIs
Publication statusPublished - Oct 2019

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, 108 or up to 109 cells. 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.

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