| Literature DB >> 31591593 |
Francesca Moroni1, Benjamin J Dwyer1, Catriona Graham2, Chloe Pass3, Laura Bailey3, Lisa Ritchie3, Donna Mitchell3, Alison Glover3, Audrey Laurie3, Stuart Doig3, Emily Hargreaves3, Alasdair R Fraser3, Marc L Turner3, John D M Campbell3, Neil W A McGowan3, Jacqueline Barry4, Joanna K Moore1, Peter C Hayes5, Diana J Leeming6, Mette J Nielsen6, Kishwar Musa6, Jonathan A Fallowfield5, Stuart J Forbes7.
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.Entities:
Mesh：
Year: 2019 PMID： 31591593 DOI： 10.1038/s41591-019-0599-8
Source DB: PubMed Journal: Nat Med ISSN： 1078-8956 Impact factor: 53.440