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Cited by 118Liver Disease and TransplantationMesenchymal stem cell researchLiver physiology and pathology

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Autologous Bone Marrow Mononuclear Cell Transplantation in Patients with Decompensated Alcoholic Liver Disease: A Randomized Controlled Trial

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Spahr, Laurent, Chalandon, Yves, Terraz, Sylvain, Kindler, Vincent, Rubbia-Brandt, Laura, Frossard, Jean-Louis, Breguet, Romain, Lanthier, Nicolas, Farina, Annarita, Passweg, Jakob, Becker, Christoph D., Hadengue, Antoine·2013·PLoS ONE
DOI 10.1371/journal.pone.0053719PMC PMC3544843
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Abstract

OBJECTIVE: Impaired liver regeneration is associated with a poor outcome in patients with decompensated alcoholic liver disease (ALD). We assessed whether autologous bone marrow mononuclear cell transplantation (BMMCT) improved liver function in decompensated ALD. DESIGN: 58 patients (mean age 54 yrs; mean MELD score 19, all with cirrhosis, 81% with alcoholic steatohepatitis at baseline liver biopsy) were randomized early after hospital admission to standard medical therapy (SMT) alone (n = 30), including steroids in patients with a Maddrey's score ≥32, or combined with G-CSF injections and autologous BMMCT into the hepatic artery (n = 28). Bone marrow cells were harvested, isolated and reinfused the same day. The primary endpoint was a ≥3 points decrease in the MELD score at 3 months, corresponding to a clinically relevant improvement in liver function. Liver biopsy was repeated at week 4 to assess changes in Ki67+/CK7+ hepatic progenitor cells (HPC) compartment. RESULTS: Both study groups were comparable at baseline. After 3 months, 2 and 4 patients died in the BMMCT and SMT groups, respectively. Adverse events were equally distributed between groups. Moderate alcohol relapse occurred in 31% of patients. The MELD score improved in parallel in both groups during follow-up with 18 patients (64%) from the BMMCT group and 18 patients (53%) from the SMT group reaching the primary endpoint (p = 0.43 (OR 1.6, CI 0.49-5.4) in an intention to treat analysis. Comparing liver biopsy at 4 weeks to baseline, steatosis improved (p<0.001), and proliferating HPC tended to decrease in both groups (-35 and -33%, respectively). CONCLUSION: Autologous BMMCT, compared to SMT is a safe procedure but did not result in an expanded HPC compartment or improved liver function. These data suggest either insufficient regenerative stimulation after BMMCT or resistance to liver regenerative drive in patients with decompensated alcoholic cirrhosis. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN83972743.

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Figures

Figure 1 Flowchart of patients’ selection according to CONSORT guidelines and design of the study.
Figure 1 Flowchart of patients’ selection according to CONSORT guidelines and design of the study.CC BY · PubMed Central
Figure 2 Box-plot (median value, lower and upper quartile) representation of the changes in MELD score during the 3-month follow-up period. The values of the BMMCT and SMT groups appear in grey and white, respectively. * p<0.05 versus baseline value.
Figure 2 Box-plot (median value, lower and upper quartile) representation of the changes in MELD score during the 3-month follow-up period. The values of the BMMCT and SMT groups appear in grey and white, respectively. * p<0.05 versus baseline value.CC BY · PubMed Central
Figure 3 Percent of patients in each group who reached the primary endpoint at 3 months (p = 0.43).
Figure 3 Percent of patients in each group who reached the primary endpoint at 3 months (p = 0.43).CC BY · PubMed Central
Figure 4 Box-plot (median value, lower and upper quartile) representation of AFP serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.
Figure 4 Box-plot (median value, lower and upper quartile) representation of AFP serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.CC BY · PubMed Central
Figure 5 Box-plot (median value, lower and upper quartile) representation of HGF serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.
Figure 5 Box-plot (median value, lower and upper quartile) representation of HGF serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.CC BY · PubMed Central
Figure 6 Box-plot (median value, lower and upper quartile) representation of TGFβ serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.
Figure 6 Box-plot (median value, lower and upper quartile) representation of TGFβ serum values in BMMCT (grey boxes) and SMT groups (white boxes) at baseline and at 3 months. * p<0.01 versus baseline.CC BY · PubMed Central

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Metadata

Authors
Spahr, L., Chalandon, Y., Terraz, S., Kindler, V., Rubbia-Brandt, L., Frossard, J.-L., Breguet, R., Lanthier, N., Farina, A., Passweg, J., Becker, C. D., & Hadengue, A.
Affiliations
University Hospital of Geneva (CH)
Corresponding author
Spahr, Laurent
ORCID
Venue
PLoS ONE
Publisher
Public Library of Science (PLoS)
Published
2013-01-14
Volume
8
Issue
1
Pages
e53719
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0053719
PMC
PMC3544843
OpenAlex
W1985534351
Cited by
118
References
50
Citations by year
2026: 3 · 2025: 8 · 2024: 2 · 2023: 7 · 2022: 12 · 2021: 6 · 2020: 7 · 2019: 11 · 2018: 10 · 2017: 9 · 2016: 13 · 2015: 11 · 2014: 12 · 2013: 7
FWCI
8.92
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Archive ouverte UNIGE (University of Geneva) (publishedVersion, other-oa)
  • Digital Access to Libraries (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by)
  • Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
Funders
  • American Association for the Study of Liver Diseases
  • Louis-Jeantet Foundation
  • Faculté de Médecine, Université de Genève
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Mesenchymal stem cell research
  • Health Sciences › Medicine › Hepatology › Liver physiology and pathology
Keywords
autologous bone marrow mononuclear cell transplantation, alcoholic cirrhosis, alcoholic steatohepatitis, liver regeneration, hepatic progenitor cells, MELD score, granulocyte colony-stimulating factor, liver function, alcohol relapse
MeSH terms
Adolescent, Adult, Aged, Female, Hepatic Artery, Humans, Liver, Liver Diseases, Alcoholic, Male, Middle Aged, Regeneration, Time Factors, Transplantation, Autologous, Biomarkers, Bone Marrow Transplantation, Cytokines, Recovery of Function, Hepatocytes, Stem Cell Transplantation, Cell Proliferation, Young Adult

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