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Safety profile of autologous macrophage therapy for liver cirrhosis
Open accessAbstract
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 10 7, 10 8 or up to 10 9 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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“During 12 months of follow-up, 70 AEs were documented, with 44% considered related to the transplantation, but none of these AEs had a Common Terminology Criteria for Adverse Events (CTCAE) severity grading over 2.”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [22]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“in vitro expanded autologous BMDMs respectively through a peripheral vein [22].”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [22]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
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“recent clinical trials have provided evidence that the administration of autologous macrophage therapy for liver fibrosis is safe, although the nature of these trials precluded efficacy assessment (52, 53).”
From Impaired TIM4-mediated efferocytosis by liver macrophages contributes to fibrosis in metabolic dysfunction–associated steatohepatitis (2025) · cites this paper as [52]
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“Phase I studies demonstrated that macrophage infusion was safe and well-tolerated, and even showed improvement in some serum biomarkers after treatment (C3M, PRO-C3, and ELF) (176).”
From Targeting macrophages in liver fibrosis (2026) · cites this paper as [176]
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“A reduction of MELD scores was observed in six of the nine patients 90 days following macrophage infusion, and in seven of the nine patients one year post-infusion.”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [22]
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“Furthermore, the non-invasive measures of LC, such as serological markers of type-III collagen turnover, improved at day 90.”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [22]
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“A phase I trial (Moroni et al., 2019) first demonstrated that reinfusing autologous monocyte-derived macrophages (MDMs) into cirrhosis patients is safe and led to observed improvements in Model for End-Stage Liver Disease (MELD) score and liver stiffness (74).”
From Macrophage duality in liver diseases: heterogeneity, plasticity, and the quest for precision therapeutics (2026) · cites this paper as [74]
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“The feasibility of the approach was further demonstrated by a Phase I clinical trial that injected autologous macrophages that express markers of tissue repair and inflammation resolution and showed an improvement in liver function and reduction of fibrosis markers (118).”
From Immunoregulation of Liver Fibrosis: New Opportunities for Antifibrotic Therapy (2024) · cites this paper as [118]
In the citing paper
“In this proof-of-concept trial, apheresis-derived autologous CD14+ monocytes were differentiated ex vivo into a restorative phenotype (CD14+, high 25F9, CD206, CD163 and CD169). The single injection of different doses of these macrophages appeared safe and was associated with a (slight) reduction in the model of end-stage liver disease score.151”
From An integrated view of anti-inflammatory and antifibrotic targets for the treatment of NASH (2023) · cites this paper as [151]
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“The feasibility of such an approach was shown in a phase I clinical trial including nine patients with compensated cirrhosis.151”
From An integrated view of anti-inflammatory and antifibrotic targets for the treatment of NASH (2023) · cites this paper as [151]
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Metadata
- Authors
- Moroni, F., Dwyer, B. J., Graham, C., Pass, C., Bailey, L., Ritchie, L., Mitchell, D., Glover, A., Laurie, A., Doig, S., Hargreaves, E., Fraser, A. R., Turner, M. L., Campbell, J. D. M., McGowan, N. W. A., Barry, J., Moore, J. K., Hayes, P. C., Leeming, D. J., Nielsen, M. J., Musa, K., Fallowfield, J. A., & Forbes, S. J.
- Affiliations
- MRC Centre for Regenerative Medicine (GB)
- University of Edinburgh (GB)
- Scottish National Blood Transfusion Service (GB)
- Guy's Hospital (GB)
- Centre for Inflammation Research (GB)
- Nordic Bioscience (Denmark) (DK)
- Corresponding author
- Forbes, Stuart J.
- ORCID
- Venue
- Nature Medicine
- Published
- 2019-10
- Volume
- 25
- Issue
- 10
- Pages
- 1560-1565
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- OpenAlex
- W2977548937
- Cited by
- 202
- References
- 35
- Citations by year
- 2026: 16 · 2025: 35 · 2024: 38 · 2023: 25 · 2022: 26 · 2021: 40 · 2020: 20 · 2019: 1
- FWCI
- 13.86
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Locations
- Nature Medicine (publishedVersion)
- PubMed (publishedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Funders
- RCUK | Medical Research Council (MR/M007588/1)
- RCUK | MRC | Medical Research Foundation (MR/M007588/1)
- Topics
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Mesenchymal stem cell research
- Keywords
- liver cirrhosis, liver fibrosis, leukapheresis, safety and tolerability, dose-limiting toxicity, macrophage activation syndrome, ascites
- MeSH terms
- Aged, Dose-Response Relationship, Immunologic, Female, Humans, Liver, Liver Cirrhosis, Liver Regeneration, Macrophages, Male, Middle Aged, End Stage Liver Disease, Cell- and Tissue-Based Therapy
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