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Safety profile of autologous macrophage therapy for liver cirrhosis.
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; Forbes, Stuart J.
Afiliación
  • Moroni F; MRC Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, UK.
  • Dwyer BJ; MRC Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, UK.
  • Graham C; Edinburgh Clinical Research Facility, University of Edinburgh, Edinburgh, UK.
  • Pass C; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Bailey L; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Ritchie L; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Mitchell D; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Glover A; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Laurie A; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Doig S; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Hargreaves E; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Fraser AR; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Turner ML; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Campbell JDM; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • McGowan NWA; Tissues, Cells and Advanced Therapeutics, Scottish National Blood Transfusion Service (SNBTS), Edinburgh, UK.
  • Barry J; Cell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, UK.
  • Moore JK; MRC Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, UK.
  • Hayes PC; Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.
  • Leeming DJ; Nordic Bioscience, Fibrosis Biology and Biomarkers, Herlev, Denmark.
  • Nielsen MJ; Nordic Bioscience, Fibrosis Biology and Biomarkers, Herlev, Denmark.
  • Musa K; Nordic Bioscience, Fibrosis Biology and Biomarkers, Herlev, Denmark.
  • Fallowfield JA; Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.
  • Forbes SJ; MRC Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, UK. stuart.forbes@ed.ac.uk.
Nat Med ; 25(10): 1560-1565, 2019 10.
Article en En | MEDLINE | ID: mdl-31591593
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad Hepática en Estado Terminal / Tratamiento Basado en Trasplante de Células y Tejidos / Cirrosis Hepática / Macrófagos Tipo de estudio: Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad Hepática en Estado Terminal / Tratamiento Basado en Trasplante de Células y Tejidos / Cirrosis Hepática / Macrófagos Tipo de estudio: Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos